Mild Cognitive Impairment Clinical Trial
— PRIMAOfficial title:
Promoting Reengagement in Daily Meaningful Activity (PRIMA) Intervention for Adults With Mild Cognitive Impairment and Their Caregivers
Verified date | December 2023 |
Source | Indiana University |
Contact | Yvonne Y Lu, PhD |
Phone | 3172782042 |
yuelu[@]iu.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators developed and tested the Daily Engagement in Meaningful Activities (DEMA) intervention to improve life satisfaction and health outcomes for patients and caregivers. DEMA is a positive health focused, theoretically grounded, tailored, family-centered, multi-faceted intervention. Over 7 session, dyads work with a nurse to 1) identify meaningful activities, assess capacity, problem-solve barriers, and establish routines for engagement and 2) learn more about MCI by working through six Self-Management Toolkit topics (e.g., benefits of meaningful activity; planning the future). The investigators' purpose is to evaluate the efficacy of DEMA in a two-group randomized controlled trial with 200 patient/caregiver dyads (DEMA intervention vs. the information support (IS) attention control group).
Status | Recruiting |
Enrollment | 400 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Both the MCI patient and caregiver must consent to participate and have a phone at home or daily access to a telephone to be eligible for the study. MCI patients will be eligible, if they: - are aged > 59 years old; - able to speak and read English; - have both self or informant reported cognitive complaints, - have MoCA score = 15 to 25 - are in the normal range in performance of daily living tasks based on functional impairment absent: a check box of Functional Activities Questionnaire (FAQ) has no score =2); Family caregivers (spouse, other family members or friends) will be eligible, if they - self-identify as care partner - are aged = 18 years old, - have primary responsibility for providing unpaid care to an MCI patient, along with monitoring safety and providing social support; - are able to speak and read English; - are oriented to persons, places, and time (having a 6-item Screener score of 4 or above). Exclusion Criteria: - MCI patients and family caregivers will be excluded, if the MCI patient or family caregiver dyads participants are: - a diagnosed untreated severe major depression, or receiving advanced cancer treatment or hospice care, - receiving dialysis, - severe hearing loss and no hearing aids, - have no access to a telephone - the family caregiver has significant cognitive impairment that may hinder participation (6-item MMSE < 4). |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University Alzhemier Disease Research Center | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University | National Institute of Nursing Research (NINR) |
United States,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Confidence Scale | The Nowotny Confidence Subscale (NCS) of the Nowotny Hope Scale is a self-report of confidence in one's own ability, which uses a 4-point Likert response format of strongly agree to strongly disagree. Content validity was established by literature review and an expert panel (Nowotny, 1989). The total score ranges from 8 to 32 and a higher score indicates better sense of confidence. .Concurrent validity of the entire scale was established with the Beck Hopelessness Scale at r = -0.47. The internal reliability was 0.83 to 0.92 (Nowotny, 1989.) The scale takes about 3 minutes to complete it. | Change Baseline Confidence Scale at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention | |
Other | The subscale of Communication and Affective Responsiveness (CAR) | The subscale of Communication and Affective Responsiveness of The Family Assessment Device (FAD) is a 12-item, self-report questionnaire with 4-point responses Likert Scale (from 1 = strongly disagree to 4 = strongly agree) (Miller, Epstein, Bishop, & Keitner, 1985). These scales will be used to measure the satisfaction with communication with family members. The total score ranges from 12 to 48.The internal reliability was .90 (Miller et al., 1985). The scale takes about 4 minutes to complete it. | Change from Baseline subscale of CAR at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention | |
Other | Dementia Deficits Scale (DDS) (Patient vs. Caregiver Versions) | The Dementia Deficits Scale (DDS), patient version is used to assess MCI patients' awareness of the performance capacity (Snow et al., 2004). This multidimensional scale measures memory, attention, orientation, language, executive functioning, emotional and behavioral symptoms, and functional abilities. The patient rates him or herself performance capacity. Items are coded "0" if the deficit or symptom is not present or "1" if the deficit/symptom is present. The total score ranges from 0 to 35. The internal reliability for DDS with patient version was 0.77 to 0.91(Snow et al., 2004). The scale takes about 12 minutes to complete it. | Change from Baseline DDS at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention | |
Other | The Canadian Occupational Performance Measure (COPM) | The Canadian Occupational Performance Measure (COPM)-Importance subscale will be used to assess MCI patient's meaningful daily activities (Law et al., 1994). It is a generic measure with a semi-structured interview in which the patient is encouraged to identify problems in self-care, productivity or leisure activities. It is a widely known and valuable tool to assist in client-centered physical activity intervention studies. It concerns those activities the patient wants, needs, or is expected to do, but cannot to do, or those in which the patient is not satisfied with current performance. Then the patients will rate importance of the problems on a 10-point scale from "Not important at all" to "extremely important" (score 10). The internal reliability was 0.86 to 0.95 (Law et al., 1994) | Change from Baseline COPM at Session 1(at Week 1), Session 2(at Week 2), Session 3 (at Week 4), Session 4 (at Week 6), Session 5 (at Week 8), Session 6 (at Week 10); Session 7 (at Week 12), 10 days post-, 3 months post-, and 6 months-post intervention | |
Other | The modified Credibility/Expectancy Questionnaire (CEQ) | The 6-item Credibility/Expectancy Questionnaire (CEQ) is used to assess participants (patient/caregivers) perception of intervention credibility/expectancy (Devilly & Borkovece, 2000). This multidimensional scale measures credibility and expectancy of intervention or program. The scale is from 1 to 9. The item coded 1 to 3 for "Not at all", 4 to 6 for Somewhat, or Very for 7 to 9. The items 1, 2, and 3 are loading on factor credibility; the items 4, 5, and 6 are loading on factor expectancy. The total score ranges from 1 to 42. The internal reliability of CEQ was 0.79 to 0.90 (Devilly & Borkovece, 2000). The scale takes about 3 minutes to complete it. | 10 days post-intervention evaluation | |
Other | Six-item Screener [Completed by caregiver] | The six-item screener is a subset of the full MMSE, a brief cognitive screener with acceptable sensitivity (86%) and specificity (91%) for identifying subjects with cognitive impairment (Callahan, Unverzagt, Hui, Perkins, & Hendrie, 2002). It can be readily incorporated into an initial patient assessment of eligibility. The scale takes only 1 to 2 minutes to complete as compared with 7 to 15 minutes for longer scales. In addition, the six-item screener can be easily administered by telephone or in face-to-face interviews. The research can alter the cut-off score to match the goals of the study and the targeted population and diagnosing dementia using a cut-off score of 5 (range of possible scores 0-8 (Callahan et al., 2002). This measure has been used for identify family caregivers with cognitive impairment and it took only 2 minutes to complete it. | Pre-consent | |
Other | The Montreal Cognitive Assessment (MoCA) [Completed by Patient] | The Montreal Cognitive Assessment (MoCA) is a rapid screening instrument designed to help health professionals detect mild cognitive dysfunction (Nasreddine et al., 2003; Nasreddine et al., 2005). It assess numerous cognitive domains: attention and concentration, executive functions, memory, language, visuoconstrutional skills, conceptual thinking, calculation, and orientation. Time to administer is approximately 10 minutes. The total possible scores is 30 points; a score of 26 or above is considered normal. The test-reliability was .92 and the internal consistency was .83 ( Nasreddine et al., 2005). The high sensitivity of MoCA was found for identifying both AD and MCI patients (100% and 90%, respectively), specificity of the MoCA (defined as the ability to identify non-cognitively impaired subjects) was 87%. Positive and negative predictive values were also high for both AD patients (89% and 100%, respectively) and MCI patients (89% and 91%, respectively) (Nasreddine et al., 2005). | Pre-consent | |
Other | University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) [Completed by patients] | To further evaluate patient ability to provide informed consent, we will now use the 10-item (total score range 0-20) University of California, San Diego Brief Assessment of Capacity to Consent (UBACC):[23] internal consistency, Cronbach's ? = 0.77; interrater reliability, r = 0.44-0,73; concurrent validity acceptable, sensitivity (89%) and high specificity (100%);[23] and takes less 5 minutes to complete. Following a basic, verbal description of the study, potential patients will next complete the UBACC. The cut off point for patient self-consent is > to 14. | Pre-consent | |
Other | Demographic Profile and Comorbidity Condition | The demographic profile is completed by patient/caregiver and it has 32 items and includes MCI patient and caregiver demographic characteristics: recruitment setting, age, gender, education, relationship with patient, social economic status. Patient's MoCA scores and FAQ scores, and comorbidity condition (i.e. stroke, heart disease, or others). These are antecedent variables. Time to administer the Demographic Profile is Approximately. | at Baseline, Pre-intervention Evaluation | |
Other | Patient's Anti-depression medication and Anxiety Medication (Medication type, dosage, and using time frame) | MCI patient/caregivers anti-depression medication and anti-anxiety medication information/using anti-depression/anti-anxiety medication or not (i.e., selective serotonin reuptake inhibitors [SSRIs]; Zoloft, Prozac, et al.) | Changes from Baseline patient's Anti-depression and Anxiety Medication at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention | |
Other | Functional Activities Questionnaire (FAQ) [for MCI patient] | Functional Activities Questionnaire (FAQ) is, a 10-item, used to assess functional activities, which uses a 4-point Likert response format from "normal = 0" to "dependent = 3"(Mayo, 2016; Pfeffer, Kurosaki, Harrah, Chance, & Filos, 1982) The range of FAQ scores are from 0-30 and a cut-point of 9 (dependent in 3 or more activities) is recommended to indicate impaired function and possible cognitive impairment. The scale sensitivity is ranging from 85% to 98% and specificity ranging from 71% to 91% (Mayo, 2016; Pfeffer et al., 1982). Time to administer is approximately 5 minutes. FAQ is completed by patient or obtained from the medical record after receiving permission form the MCI patient. The FAQ has been used as part of the NIH Funded, Indiana Alzheimer Disease Center Uniform Data Set. | Pre-consent | |
Primary | Life satisfaction | The Life Satisfaction Index for the Third Age (LSITA) Scale-Short Form, is a 12-item with a 6-point response scale (ranging from "1" Strongly disagree to "6" strongly agree) (Barrett & Murk, 2006). It is a measure of the overall construct of Life Satisfaction. It has been commonly used in older populations. Possible range of total scores is 12-72 and higher scores indicate better functioning. The total score ranges from 12 to 72.The reliability of the LSITA-SF scale was .90 (Barrett & Murk, 2006). The scale takes about 3 minutes to complete it. The LSITA is completed by patient and caregiver separately. | Change from Baseline Life Satisfaction at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention | |
Secondary | Patient Health Questionnaire-9 Items (PHQ-9) | Patient Health Questionnaire-9 Items (PHQ-9) is used to measure emotional function (Kroenke, Spitzer, & Williams, 2001). The PHQ-9 contains nine questions about symptoms. It has been widely used in older populations. The depression severity levels are: The scores 0 -4 indicate none, the scores between 5 to 9 indicate mild depression; the score between 10-14 indicates moderate depression; the scores between 15 to 19 indicate moderately severe depression, the scores between 20 to 27 indicate severe depression. The internal reliability was 0.83 to 0.92 (Kroenke et al., 2001). The scale takes about 3 minutes to complete it. The PHQ-9 is completed by patient and caregiver separately. | Change from Baseline PHQ-9 at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention | |
Secondary | The General Anxiety Disorder 7-item (GAD-7) | The General Anxiety Disorder 7-item (GAD-7), four-point Liker scale is used to measure emotional function and it contains 7 questions about anxiety (Spitzer, Kroenke, Williams, & Lowe, 2006). It has been widely used in older populations. The GAD-7 scale score ranges from 0 to 21 and high scores indicates perceiving high level of anxiety. The internal reliability was 0.92 and test-retest reliability was 0.83 (Spitzer et al., 2006). The scale takes about 3 minutes to complete it. The GAD-7is completed by patient and caregiver separately. | Change from Baseline GAD-7 at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention | |
Secondary | Alzheimer Disease Cooperative Study MCI-Activities of Daily Living Inventory [ADCS-MCI-ADL Scale] | The 23-item ADCS-MCI-ADL Scale has good test-retest reliability, will be utilized to assess performance functioning in MCI patients (Galasko et al., 1997; Douglas Galasko et al., 2006; Pedrosa et al., 2010). The ADCS-ADL includes 18 items from traditional basic ADL scales and 5 items from instrumental activities of daily living scales (IADL) The possible range of total scores for the ADL Scale is 0-53 and higher scores indicate better functioning. The internal reliability was .91( Galasko et al., 1997; Douglas Galasko et al., 2006; Pedrosa et al., 2010). The scale takes about 15 minutes to complete it. | Change from Baseline ADCS-MCI-ADL at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention | |
Secondary | Relationship Assessment Scale (RAS) | The Relationship Assessment Scale is a 7-item, 5 points Likert scale designed to measure general relationship satisfaction (Graham, Kunik, Doody, & Snow, 2005). The RAS was produces more reliable scores when administered to older individuals, older relationship, and married couples but it was intended to be applicable to a wide range of relationship types (Graham et al., 2005). Respondents answer each item using a 5-point scale ranging from 1 (low satisfaction) to 5 (high satisfaction). The total score ranges from 7 to 35.The internal reliability was .86-.87. The scale takes about 3 minutes to complete it. | Change from Baseline RAS at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention | |
Secondary | Caregiving Outcomes Scale (COS) | The Bakas Caregiving Outcomes Scale (COS), a 15-item with a 7-point scale, self-report inventory, will be utilized to assess family caregiver outcomes. The scale has been used in family caregivers of those with a variety of other chronic conditions (Bakas, Champion, Perkins, Farran, & Williams, 2006; Pressler, 2008). It is one of recommendation instruments that can be used to identify priority areas for nursing intervention designed to improve caregivers' outcomes (Bakas et al., 2006; Deeken, Taylor, Mangran, Yabroff, & Ingham, 2003). It includes caregiver's financial well-being, level of energy, role functioning, physical functioning, and general health. The internal consistency reliability was provided alpha = .90 (Bakas et al., 2006). The scale takes about 5 minutes to complete it. | Change from Baseline COS at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention |
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