Pain Clinical Trial
— HHOfficial title:
Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation
This study aims to evaluate behavioral interventions in conjunction with medical rehabilitation to promote functional health in patients recovering from orthopedic surgery. Half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits. The other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. Both groups will undergo several physical and cognitive assessments.
Status | Recruiting |
Enrollment | 124 |
Est. completion date | November 30, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: 1. Patients with a minimum age of 40 years, no maximum age limit, planning on having a hip or knee arthroplasty. 2. The ability to communicate during the screening process (e.g., no aphasia or other severe language impairment). 3. Meet DSM-5 criteria for insomnia disorder assessed by Duke Structured Interview for Sleep Disorders. 4. Score =8 on the Insomnia Severity Index (ISI) or =5 on the Pittsburgh Sleep Quality Index (PSQI). 5. Referral and attendance of medical rehabilitation post-discharge. Exclusion Criteria: 1. Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in the past year). 2. Presence of psychotic disorder, substance abuse or dependence, or bipolar disorder assessed by MINI International Neuropsychiatric Inventory (to increase generalizability other psychiatric comorbidities such as depression or anxiety will not be excluded). 3. Untreated comorbid sleep disorders based on structured diagnostic interview including: narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea risk. 4. Cognitive impairment defined as <20 on the Mini Mental Status Exam (MMSE) that could potentially limit comprehension of the intervention. Note, while an MMSE of <24 is often used as a cutoff for cognitive impairment, we do not wish to exclude those with mild cognitive problems from this study as there is evidence that individuals with mild cognitive problems still benefit from insomnia treatments. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Medical Branch | Galveston | Texas |
United States | Baylor College of Medicine Medical Center | Houston | Texas |
United States | Kelsey Seybold Clinic | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | PROMIS Pain Intensity | The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'. | 7-14 days before scheduled surgery | |
Other | PROMIS Pain Intensity | The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'. | 7-14 days after hospital discharge | |
Other | PROMIS Pain Intensity | The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'. | 7-14 days after completing the 8 week intervention period | |
Other | PROMIS Pain Intensity | The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'. | 6 months after completing the intervention | |
Other | PROMIS Pain Interference | The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'. | 7-14 days before schedule surgery | |
Other | PROMIS Pain Interference | The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'. | 7-14 days after hospital discharge | |
Other | PROMIS Pain Interference | The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'. | 7-14 days after completing the 8 week intervention period | |
Other | PROMIS Pain Interference | The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'. | 6 months after completing the intervention | |
Other | PROMIS Fatigue | The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living. | 7-14 days before scheduled surgery | |
Other | PROMIS Fatigue | The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living. | 7-14 days after hospital discharge | |
Other | PROMIS Fatigue | The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living. | 7-14 days after completing the 8 week intervention period | |
Other | PROMIS Fatigue | The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living. | 6 months after completing the intervention | |
Other | PROMIS Emotional Distress-Depressesion | The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days. | 7-14 days before scheduled surgery | |
Other | PROMIS Emotional Distress-Depressesion | The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days. | 7-14 days after hospital discharge | |
Other | PROMIS Emotional Distress-Depressesion | The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days. | 7-14 days after completing the 8 week intervention period | |
Other | PROMIS Emotional Distress-Depressesion | The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days. | 6 months after completing the intervention | |
Other | PROMIS Psychosocial Illness Impact - Negative | The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'. | 7-14 days before scheduled surgery | |
Other | PROMIS Psychosocial Illness Impact - Negative | The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'. | 7-14 days after hospital discharge | |
Other | PROMIS Psychosocial Illness Impact - Negative | The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'. | 7-14 days after completing the 8 week intervention period | |
Other | PROMIS Psychosocial Illness Impact - Negative | The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'. | 6 months after completing the intervention | |
Other | PROMIS Satisfaction with Social Roles and Activities | The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'. | 7-14 days before scheduled surgery | |
Other | PROMIS Satisfaction with Social Roles and Activities | The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'. | 7-14 days after hospital discharge | |
Other | PROMIS Satisfaction with Social Roles and Activities | The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'. | 7-14 days after completing the 8 week intervention period | |
Other | PROMIS Satisfaction with Social Roles and Activities | The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'. | 6 months after completing the intervention | |
Other | PROMIS Ability to Participate in Social Roles and Activity | The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'. | 7-14 days before scheduled surgery | |
Other | PROMIS Ability to Participate in Social Roles and Activity | The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'. | 7-14 days after hospital discharge | |
Other | PROMIS Ability to Participate in Social Roles and Activity | The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'. | 7-14 days after completing the 8 week intervention period | |
Other | PROMIS Ability to Participate in Social Roles and Activity | The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'. | 6 months after completing the intervention | |
Other | Rehabilitation Attendance | Weekly rehabilitation attendance will be measured via patient self-report. | From hospital discharge until subject notifies study staff they have stopped attending, on average around 12 weeks. | |
Other | Plasma IL-6 | Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6). | 7-14 days before scheduled surgery | |
Other | Plasma IL-6 | Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6). | 7-14 days after hospital discharge | |
Other | Plasma IL-6 | Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6). | 7-14 days after completing the 8 week intervention period | |
Other | Plasma IL-6 | Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6). | 6 months after completing the intervention | |
Other | Plasma CRP | Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP) | 7-14 days before scheduled surgery | |
Other | Plasma CRP | Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP) | 7-14 days after hospital discharge | |
Other | Plasma CRP | Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP) | 7-14 days after completing the 8 week intervention period | |
Other | Plasma CRP | Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP) | 6 months after completing the intervention | |
Other | Plasma VWF | Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF) | 7-14 days before scheduled surgery | |
Other | Plasma VWF | Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF) | 7-14 days after hospital discharge | |
Other | Plasma VWF | Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF) | 7-14 days after completing the 8 week intervention period | |
Other | Plasma VWF | Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF) | 6 months after completing the intervention | |
Other | Plasma TNFalpha | Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa) | 7-14 days before scheduled surgery | |
Other | Plasma TNFalpha | Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa) | 7-14 days after hospital discharge | |
Other | Plasma TNFalpha | Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa) | 7-14 days after completing the 8 week intervention period | |
Other | Plasma TNFalpha | Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa) | 6 months after completing the intervention | |
Other | Medication Monitoring Form | Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class. | 7-14 days before schedule surgery | |
Other | Medication Monitoring Form | Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class. | 7-14 days after hospital discharge | |
Other | Medication Monitoring Form | Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class. | 7-14 days after completing the 8 week intervention period | |
Other | Medication Monitoring Form | Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class. | 6 months after completing the intervention | |
Other | Treatment Expectation Questionnaire | This questionnaire 8-question measure provided before treatment. It will be used to collect information on participants' reasons for treatment as well as their expectations of treatment (e.g., its effectiveness, the amount of effort it will take, confidence in their doctor). Participant will mark answers to each question on a visual analog scale (e.g., from Not Confident at all to Very Confident). | Immediately prior to beginning the intervention | |
Other | Treatment Satisfaction Questionnaire | Treatment Satisfaction Scale is a 10-question measure provided after treatment. It measures participants' perceptions on the treatment's effectiveness, benefits, and influence on quality of life (e.g., improvements in work productivity, mood, etc.). Questions are measured on a 5-point Likert scale from Not at all to Very Much. | Immediately following the completion of the intervention | |
Primary | Insomnia Severity Index (ISI) | ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of = 8 is optimal to detect clinical levels of insomnia. | 7-14 days before scheduled surgery | |
Primary | Insomnia Severity Index (ISI) | ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of = 8 is optimal to detect clinical levels of insomnia. | 7-14 days after hospital discharge | |
Primary | Insomnia Severity Index (ISI) | ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of = 8 is optimal to detect clinical levels of insomnia. | 7-14 days after completing the 8 week intervention period | |
Primary | Insomnia Severity Index (ISI) | ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of = 8 is optimal to detect clinical levels of insomnia. | 6 months after completing the intervention | |
Primary | Wrist actigraphy | A wearable device will be used to measure participant sleep over seven days. | 7-14 days before scheduled surgery | |
Primary | Wrist actigraphy | A wearable device will be used to measure participant sleep over seven days. | 7-14 days after hospital discharge | |
Primary | Wrist actigraphy | A wearable device will be used to measure participant sleep over seven days. | 7-14 days after completing the 8 week intervention period | |
Primary | Wrist actigraphy | A wearable device will be used to measure participant sleep over seven days. | 6 months after completing the intervention | |
Secondary | PROMIS Physical Function (short form) | The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do' | 7-14 days before scheduled surgery | |
Secondary | PROMIS Physical Function (short form) | The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do' | 7-14 days after hospital discharge | |
Secondary | PROMIS Physical Function (short form) | The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do' | 7-14 days after completing the 8 week intervention period | |
Secondary | PROMIS Physical Function (short form) | The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do' | 6 months after completing the intervention | |
Secondary | PROMIS Mobility | The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities. | 7-14 days before scheduled surgery | |
Secondary | PROMIS Mobility | The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities. | 7-14 days after hospital discharge | |
Secondary | PROMIS Mobility | The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities. | 7-14 days after completing the 8 week intervention period | |
Secondary | PROMIS Mobility | The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities. | 6 months after completing the intervention | |
Secondary | Short Physical Performance Battery (SPPB ) motor | The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained. | 7-14 days before scheduled surgery | |
Secondary | Short Physical Performance Battery (SPPB ) motor | The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained. | 7-14 days after hospital discharge | |
Secondary | Short Physical Performance Battery (SPPB ) motor | The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained. | 7-14 days after completing the 8 week intervention period | |
Secondary | Short Physical Performance Battery (SPPB ) motor | The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained. | 6 months after completing the intervention | |
Secondary | PROMIS Applied Cognitive Abilities | The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days. | 7-14 days before scheduled surgery | |
Secondary | PROMIS Applied Cognitive Abilities | The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days. | 7-14 days after hospital discharge | |
Secondary | PROMIS Applied Cognitive Abilities | The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days. | 7-14 days after completing the 8 week intervention period | |
Secondary | PROMIS Applied Cognitive Abilities | The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days. | 6 months after completing the intervention | |
Secondary | PROMIS Applied Cognitive Abilities- General Concerns | The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days. | 7-14 days before scheduled surgery | |
Secondary | PROMIS Applied Cognitive Abilities- General Concerns | The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days. | 7-14 days after hospital discharge | |
Secondary | PROMIS Applied Cognitive Abilities- General Concerns | The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days. | 7-14 days after completing the 8 week intervention period | |
Secondary | PROMIS Applied Cognitive Abilities - General Concerns | The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days. | 6 months after completing the intervention | |
Secondary | Tele-neuropsychology (T-NP) Battery | The T-NP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall) Cognition tests will be scored. | 7-14 days before scheduled surgery | |
Secondary | Tele-neuropsychology (T-NP) Battery | The T-NP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall). Cognition tests will be scored. | 7-14 days after hospital discharge | |
Secondary | Tele-neuropsychology (T-NP) Battery | The T-NP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall). Cognition tests will be scored. | 7-14 days after completing the 8 week intervention period | |
Secondary | Tele-neuropsychology (T-NP) Battery | The TNP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall). Cognition tests will be scored. | 6 months after completing the intervention | |
Secondary | Activities of Daily Living (ADLs) | The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help" | 7-14 days before scheduled surgery | |
Secondary | Activities of Daily Living (ADLs) | The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help" | 7-14 days after hospital discharge | |
Secondary | Activities of Daily Living (ADLs) | The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help" | 7-14 days after completing the 8 week intervention period | |
Secondary | Activities of Daily Living (ADLs) | The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help" | 6 months after completing the intervention | |
Secondary | Instrumental ADLs (IADL) scale | The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format. | 7-14 days before scheduled surgery | |
Secondary | Instrumental ADLs (IADL) scale | The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format. | 7-14 days after hospital discharge | |
Secondary | Instrumental ADLs (IADL) scale | The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format. | 7-14 days after completing the 8 week intervention period and | |
Secondary | Instrumental ADLs (IADL) scale | The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format. | 6 months after completing the intervention | |
Secondary | Sleep Diary | The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments. | 7-14 days before scheduled surgery | |
Secondary | Sleep Diary | The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments. | 7-14 days after hospital discharge | |
Secondary | Sleep Diary | The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments. | During the 8 week intervention | |
Secondary | Sleep Diary | The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments. | 7-14 days after completing the 8 week intervention period | |
Secondary | Sleep Diary | The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments. | 6 months after completing the intervention | |
Secondary | Knee injury and osteoarthritis outcome score (KOOS) | This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how knee pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely. | 7-14 days before scheduled surgery | |
Secondary | Knee injury and osteoarthritis outcome score (KOOS) | This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how knee pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely. | 6 months after completing intervention | |
Secondary | Hip disability and osteoarthritis outcome score (HOOS) | This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how hip pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely. | 7-14 days before scheduled surgery | |
Secondary | Hip disability and osteoarthritis outcome score (HOOS) | This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how hip pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely. | 6 months after completing intervention | |
Secondary | StepWatch | A wearable device will measure physical activity over a seven day period. | 7-14 days before scheduled surgery | |
Secondary | StepWatch | A wearable device will measure physical activity over a seven day period. | 7-14 days after hospital discharge | |
Secondary | StepWatch | A wearable device will measure physical activity over a seven day period. | 7-14 days after completing the 8 week intervention period | |
Secondary | StepWatch | A wearable device will measure physical activity over a seven day period. | 6 months after completing the intervention |
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N/A | |
Completed |
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N/A | |
Enrolling by invitation |
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Is PNF Application Effective on Temporomandibular Dysfunction
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Completed |
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Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
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Phase 2/Phase 3 | |
Recruiting |
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Partial Breast Versus no Irradiation for Women With Early Breast Cancer
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N/A | |
Active, not recruiting |
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Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
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Completed |
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A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
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N/A | |
Completed |
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Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
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N/A | |
Completed |
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Online Automated Self-Hypnosis Program
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N/A | |
Completed |
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Can We Improve the Comfort of Pelvic Exams?
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N/A | |
Terminated |
NCT02181387 -
Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?
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Phase 4 | |
Recruiting |
NCT06032559 -
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
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Phase 3 | |
Active, not recruiting |
NCT03613155 -
Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care
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