Diabetes Mellitus Clinical Trial
— AWAREOfficial title:
The Effect of an Inter-Disciplinary Program, Including Mindfulness Based Stress Reduction, on Psychosocial Function, Pain and Metabolism in Patients With Painful Diabetic Peripheral Neuropathy
Verified date | June 2018 |
Source | Ottawa Hospital Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
By 2020, it is estimated that 3.7 million Canadians will have diabetes mellitus, with type 2 diabetes (T2DM) accounting for more than 90% of cases. Estimates of the prevalence of diabetic peripheral neuropathy among adults with T2DM range from 26% to 47%. It increases with patient age and duration of disease and it can be as high as 60 to 70% in older cohorts. Diabetic peripheral neuropathy is documented in most studies as numbness, tingling, pain and/or objective sensory changes. Pain is an early manifestation of neuropathy and may be the presenting symptom of diabetes. Even the best medications and procedures rarely relieve more than 30% of the discomfort of chronic painful conditions. Diabetic patients continue to experience debilitating and disabling pain. Pain affects our ability to work, our ability to participate in recreational activities, our mood and our relationships. It is well-established that an interdisciplinary approach is key to the treatment of some types of chronic pain, but little research has been done on the effectiveness of interdisciplinary treatments for patients suffering from painful diabetic peripheral neuropathy. The investigators will evaluate the effectiveness of an interdisciplinary approach combining medical treatment and mindfulness-based stress reduction (MBSR) to reduce disability and improve quality of life among patients with painful diabetic peripheral neuropathy. The investigators will also evaluate the impact of the program on psychological distress, pain cognitions, and biomarkers of stress and glycemic function.
Status | Completed |
Enrollment | 81 |
Est. completion date | August 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient aged > 18 years - Type 1 or Type 2 Diabetes Mellitus (receiving insulin or not) - HbA1c 6.5%-9.9% - Diagnosis of Diabetic Peripheral Neuropathy (DPN) > 1 year - Report of pain > 6 months - Score >3 on Douleur Neuropathique-4 Questionnaire - VAS completed 5/7 days; Average VAS score >4 and <9 (i.e., moderate to severe pain). - Ability to attend a minimum of 7 of 9 MBSR workshops Exclusion Criteria: - Peripheral vascular disease requiring revascularization of lower limb or amputation - Pregnant or lactating - Active alcohol or drug abuse/dependence - Previous MBSR training - Co-morbidity preventing assessment or understanding of questionnaires - Inability to speak English or French |
Country | Name | City | State |
---|---|---|---|
Canada | The Ottawa Hospital | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute | Canadian Diabetes Association |
Canada,
Nathan HJ, Poulin P, Wozny D, Taljaard M, Smyth C, Gilron I, Sorisky A, Lochnan H, Shergill Y. Randomized Trial of the Effect of Mindfulness-Based Stress Reduction on Pain-Related Disability, Pain Intensity, Health-Related Quality of Life, and A1C in Pati — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in pain-related disability, as measured by the Brief Pain Inventory. Pain interference scale at 3-month post-intervention. | The primary outcome is pain-related disability, as measured by the Brief Pain Inventory pain interference scale which consists of 7 numerical scales (0 to10) rating pain interference with general activity, mood, walking ability, work, relations with other people, sleep and enjoyment of life. | Baseline and 3 months post-intervention | |
Secondary | Change from baseline in pain severity, as measured by the Brief Pain Inventory - Pain Severity scale, at 3 months post-intervention | Pain Severity will be measured using the Brief Pain Inventory (BPI) - Pain Severity. The BPI consists of 4 numerical scales (0 to 10) rating pain severity at its worst, at its least, on average, and at the time of filling out the measure. Each severity question is analyzed individually. | Baseline and 3 months post-intervention | |
Secondary | Change from baseline in mood states, as measured by the Profile of Mood States scale, at 3 months post-intervention. | The Profile of Mood States (POMS-2A) will be used to measure mood disturbance. Participants are asked to rate 65 adjectives using a 5-point likert scale (0= not at all, to 4 = extremely) based on how they have been feeling during the past week, including the day they are filling out the questionnaire. A total mood disturbance score is calculated, as well as scores for 6 subscales: depression, tension-anxiety,anger-hostility, vigor-activity, fatigue, confusion-bewilderment. | Baseline and 3 months post-intervention | |
Secondary | Overall change in status from baseline, as measured by Patient Global Impression of Change scale, at 3 months post-intervention. | The participants perceived degree of change in overall status will be measured using the Patient Global Impression of Change (PGIC) scale. The PGIC uses a 7-point likert scale (very much worse, to very much better) to measure how much the participant feels their overall status has changed since the start of the study. | Baseline and 3 months post-intervention | |
Secondary | Change from baseline in stress, as measured by the Perceived Stress Scale, at 3 months post-intervention. | The Perceived Stress Scale (PSS) will be used to measure the participants' perceived stress levels. The PSS uses a 5-point likert scale (0=Never, to 4=Very often) to measure the degree of stress a participant has experienced over the past month. A total perceived stress score is obtained by reversing the scores on items 4, 5, 7, and 8, and then summing across all 10 items. Higher scores indicate higher perceived stress. | Baseline and 3 months post-intervention | |
Secondary | Change from baseline in depressive symptoms, as measured by the Patient Health Questionnaire - 9 scale, at 3 months post-intervention | The Patient Health Questionnaire - 9 (PHQ-9) is a 9-item scale used to assess the severity of depressive symptoms over the past two weeks and is based on Diagnostic and Statistical Manual (DSM- V) diagnostic criteria for major depression. Total scores range from 0 to 27, and clinical cut-points correspond to mild, moderate, moderately severe, and severe depression. | Baseline and 3 months post-intervention | |
Secondary | Change from baseline in pain catastrophizing, as measured by the Pain Catastrophizing Scale, at 3 months post-intervention. | The Pain Catastrophizing Scale (PCS) is a 13-item instrument which will evaluate the degree to which patients have negative self-statements and catastrophizing thoughts and ideations when in pain. The PCS uses a 5-point likert scale (0=not at all, 4=all the time) and consists of three subscales (rumination, magnification, helplessness). | Baseline and 3 months post-intervention | |
Secondary | Change from baseline in mindfulness, as measured by the Five Facet Mindfulness Questionnaire, at 3 months post-intervention. | Mindfulness will be measured using the Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ is a 39-item instrument measuring five aspects of mindfulness: Non-reactivity to inner experience, observing, describing, acting with awareness, and non-judging of experience. Participants are asked to use a 5-point Likert-type scale (1 = never or rarely true 5 = very often or always true) to rate how true of them they believe each statement to be. | Baseline and 3 months post-intervention | |
Secondary | Change from baseline in quality of life, as measured by the Short-Form-12 Health Survey, at 3 months post-intervention. | Quality of life will be measured by the Short-Form-12 Health Survey (SF-12v.2). The SF-12v2 is a brief, twelve-item self-report measure based on the Short-Form-36. It includes items assessing eight health domains, such as bodily pain, social functioning, role limitations due to physical health, and general health perceptions. Two summary scores, the physical composite scale (PCS) and mental composite scale (MCS) are computed based on the 12 items. Scores range from 0 to 100, with higher scores indicating greater quality of life. | Baseline and 3 months post-intervention | |
Secondary | Change from baseline in quality of life, as measured by the Neuropathy-Specific Quality of Life Questionnaire (NeuroQOL). | The NeuroQoL was designed for and validated in patients with diabetic peripheral neuropathy and it captures the key dimensions of the patient's experience. Factor analysis revealed 3 physical symptom measures and 2 psychosocial functioning measures with good reliability (a = 0.86 - 0.95). This instrument was more strongly associated with severity of DPN than the SF-12 and more fully mediated the relationship between DPN and overall quality of life. | Baseline and 3 months post-intervention | |
Secondary | Change from baseline in quality of health and life, as measured by the The Summary of Diabetes Self-Care Activities (SDSCA). | The SDSCA is an 11-item self-report measure used to assess the diet, exercise, smoking, blood glucose testing and footcare habits of patients with diabetes. The scale has been found to be valid with moderate test-retest reliability. | Baseline and 3 months post-intervention | |
Secondary | Change from baseline in adverse reactions as a result of their glycemic control, as measured by the Blood Sugar Reactions Questionnaire. | These 5 questions were developed using the "Diabetes Care Profile" from the Michigan Diabetes Research and Training Centre as a guide. | Baseline and 3 months post-intervention | |
Secondary | Change from pre-intervention in biomarkers of stress, as measured by hair cortisol levels, at 3 months post-intervention. | Cortisol is a useful biomarker of stress levels. One cm hair samples will allow us to collect data on cortisol exposure over the past month. Hair cortisol will allow us to explore the relationship between systemic exposure to a potential mediator of the interaction between pain, stress, and glucose control in patients with diabetes. This novel aspect of the present proposal may help validate an important biomarker for investigating the neuro-endocrine correlates of chronic pain. | Baseline and 3 months post-intervention | |
Secondary | Change from baseline in glycemic control, as measured by blood levels of Hemoglobin A1c. | Blood samples will be obtained from participants and the measurement of Hemoglobin A1c performed. The concentrations Hemoglobin A1c will be quantified and recorded. | Baseline and 3 months post-intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03743779 -
Mastering Diabetes Pilot Study
|
||
Completed |
NCT03786978 -
Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus
|
N/A | |
Completed |
NCT01804803 -
DIgital Assisted MONitoring for DiabeteS - I
|
N/A | |
Completed |
NCT05039970 -
A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT04068272 -
Safety of Bosentan in Type II Diabetic Patients
|
Phase 1 | |
Completed |
NCT03243383 -
Readmission Prevention Pilot Trial in Diabetes Patients
|
N/A | |
Completed |
NCT03730480 -
User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)
|
N/A | |
Recruiting |
NCT02690467 -
Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.
|
N/A | |
Completed |
NCT02229383 -
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
|
Phase 3 | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Completed |
NCT06181721 -
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
|
N/A | |
Recruiting |
NCT04489043 -
Exercise, Prediabetes and Diabetes After Renal Transplantation.
|
N/A | |
Withdrawn |
NCT03319784 -
Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
|
Phase 4 | |
Completed |
NCT03542084 -
Endocrinology Auto-Triggered e-Consults
|
N/A | |
Completed |
NCT02229396 -
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
|
Phase 3 | |
Recruiting |
NCT05544266 -
Rare and Atypical Diabetes Network
|
||
Completed |
NCT01892319 -
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
|
||
Completed |
NCT05031000 -
Blood Glucose Monitoring Systems: Discounter Versus Brand
|
N/A | |
Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A |