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Using CERS to Optimize Quality of Life for Persons With Diabetes and Chronic Pain (Living Healthy)

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ClinicalTrials.gov Identifier: NCT02538055
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : April 28, 2016
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Monika M. Safford, Weill Medical College of Cornell University

Brief Summary:
As many as 75% of people with diabetes report chronic pain. While cognitive behavioral therapy (CBT) improves pain and functioning in individuals with chronic pain, many rural and underserved communities lack resources for such programs. The investigators tested the hypothesis that a CBT-based program delivered by community health workers (CHW) can improve quality of life in individuals with diabetes and chronic pain.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Chronic Pain Behavioral: Living Healthy Behavioral: General Health Program Not Applicable

Detailed Description:

Diabetes mellitus (DM) is a growing chronic disease, affecting 20% of the population of Alabama. However, type 2 DM (90-95% of all DM) rarely occurs in isolation; 25% of all Americans report chronic pain, rising to 58-70% of community-dwellers over age 65. The National Center for Health Statistics reported in 2006 that chronic pain affected 76.2 million Americans, more than cancer, heart disease, stroke and DM combined. Despite the high prevalence of chronic pain, evidence suggests that under treatment is common. In one study, 68% of primary care physicians estimated that chronic pain was inadequately managed in their patients, and 60% thought improving physician education could help. Indeed, 40% of people with moderate to severe pain report not getting adequate relief.

Chronic pain is a significant barrier to successful DM self-care; patients with chronic pain have lower medication adherence and are less likely to exercise. Fully 60-80% of DM patients report chronic pain, and in our ENCOURAGE pilot study (Safford, PI), all but one participant did so. About 20-25% of pain may stem from neuropathy, but at least 1/3 stems from OA (osteoarthritis), and coexistence of multiple causes is common. Over half of patients >65 and 60% of women of any age report OA, demonstrating the very high prevalence of OA in this demographic group. Pain management dominated 20% of primary care visits for diabetic patients in one study, and decreased the likelihood of DM risk factor management. Not surprisingly, depressive symptoms are common in individuals with OA and chronic pain, and are also associated with non adherence to DM self-care behavior. Pain is therefore a barrier to not only quality of life, but to successful DM self-care.

While cognitive behavioral therapy (CBT) improves pain and functioning in individuals with chronic pain, many rural and underserved communities lack resources for such programs. The investigators tested the hypothesis that a CBT-based program delivered by community health workers (CHW) can improve quality of life in individuals with diabetes and chronic pain.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Using CERS to Optimize Quality of Life for Persons With Diabetes and Chronic Pain
Study Start Date : September 2011
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Placebo Comparator: General Health Program
Participants in this arm worked with a Community Health Worker (CHW) who provided a general health program that consisted of didactic information of unrelated general health information. Participants received the same number of contacts with their CHW as the intervention arm. Participants and CHW interacted by telephone 8 times over 3 months.
Behavioral: General Health Program
Participants in this arm worked with a Community Health Worker (CHW) who provided a general health program that consisted of didactic information of unrelated general health information. Participants received the same number of contacts with their CHW as the intervention arm. Participants and CHW interacted by telephone 8 times over 3 months.

Experimental: Living Healthy Program
Participants in this arm worked with a Community Health Worker (CHW) who provided the Living Healthy Program. The Living Healthy Program was a cognitive-behavioral therapy based lifestyle modification program. Participants and CHW interacted by telephone 8 times over 3 months.
Behavioral: Living Healthy
This intervention tested the effects of a community health worker delivered lifestyle modification program based on cognitive behavioral therapy on diabetes and pain outcomes in individuals with diabetes and chronic pain.




Primary Outcome Measures :
  1. Glycated hemoglobin (A1c) [ Time Frame: change in A1c in 3 months ]
    fingerstick, point of care a1c test

  2. Blood pressure [ Time Frame: Change in blood pressure measure in 3 months ]
    measured using digital automated blood pressure monitor

  3. Functional status (WOMAC) [ Time Frame: change in functional status in 3 months ]
    Assessed using the the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  4. Quality of Life (SF12) [ Time Frame: Change in quality of life measures at 3 months ]
    self report using the Short form-12 (SF12)


Secondary Outcome Measures :
  1. Pain (McGill Pain Questionnaire, ICOAP) [ Time Frame: Change in pain measures at 3 months ]
    self report using the following measures: McGill Pain Questionnaire, A measure of intermittent and Constant Osteoarthritis Pain (ICOAP),

  2. Body mass index (BMI) [ Time Frame: change in BMI in 3 months ]
    weight measured using digital scale, height measured using stadiometer

  3. Diabetes knowledge (Spoken Knowledge in Low Literacy in Diabetes Scale) [ Time Frame: change in diabetes knowledge in 3 months ]
    assessed using a modified version of the Spoken Knowledge in Low Literacy in Diabetes Scale

  4. diabetes management self-efficacy (PDSMS) [ Time Frame: change in diabetes management self efficacy measures in 3 months ]
    assessed using the Perceived Diabetes Self-Management Scale (PDSMS)

  5. Self efficacy in arthritis pain (Arthritis Self-Efficacy Scale) [ Time Frame: change in pain self efficacy measures in 3 months ]
    assessed using the Pain Self Efficacy Subscale of the Arthritis Self-Efficacy Scale

  6. Patient Activation Measure (PAM-13) [ Time Frame: change in patient activation measures in 3 months ]
    assessed using the 13 item patient activation measure (PAM-13)

  7. Perceived stress (PSS10) [ Time Frame: change in perceived stress in 3 months ]
    Assessed using the Perceived Stress Scale (PSS10)

  8. Pain coping strategies (CSQ24) [ Time Frame: change in pain coping strategies in 3 months ]
    assessed using the pain coping strategies questionnaire (CSQ24)

  9. Depressive symptoms (CESD-SF) [ Time Frame: change in depressive symptoms in 3 months ]
    assessed using the Short Form of Center for Epidemiological Studies scale (CESD-SF)

  10. Trust in physicians (Trust in Physicians Scale) [ Time Frame: change in trust in physicians in 3 months ]
    assessed using the Trust in Physicians Scale

  11. Medication Adherence (4-item Morisky Medication Adherence scale) [ Time Frame: change in medication adherence in 3 months ]
    assessed using the 4-item Morisky Medication Adherence scale

  12. Physical activity - usual daily activity [ Time Frame: change in usual daily activity at 3 months ]
    participant self-report of usual daily activity (usually sit during the day, stand or walk but don't carry or lift things often, usually lift or carry light loads, or do heavy work or carry heavy loads)

  13. Physical activity - number of days engaged in intense exercise in the past 7 days [ Time Frame: change in days of intense exercise at 3 months ]
    participant self report of number of days in the past week engaged in intense exercise (0-7 days)

  14. Physical activity - number of days walked for exercise in the past 7 days [ Time Frame: change in days of walking for exercise at 3 months ]
    participant self report of number of days in the past week walked for exercise (0-7)

  15. Physical activity - exercising when in pain questions [ Time Frame: change exercising when in pain at 3 months ]
    participant self report of exercising when experiencing pain assessed by if the participant had no days unable to walk for exercise because of pain, unable to walk because of pain but did other exercises, or unable to walk because of pain but did not other forms of exercise.

  16. Physical Activity - perception of physical activity compared to others [ Time Frame: change in perception of physical activity at 3 months ]
    participant self report of activity levels compared to others their age

  17. Diet - days eating high fat foods in the past 7 days [ Time Frame: change in the number of days of eating high fat foods at 3 months ]
    participant self report of days in the past 7 days of eating high-fat foods

  18. Diet - having a second serving at a meal in the past 7 days [ Time Frame: change in the number of days of having a second serving at a meal in the past 7 days ]
    participant self report of days in the past 7 days of having a second serving at a meal in the past 7 days

  19. Diet - eating unhealthy foods because of pain in the past 7 days [ Time Frame: change in the number of days of eating unhealthy foods because of pain in the past 7 days at 3 months ]
    participant self report of days in the past 7 days of eating unhealthy foods because of experiencing pain



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 19 or older in age
  • diagnosed with diabetes
  • under the care of a doctor
  • experienced chronic pain in the past month

Exclusion Criteria:

  • not community dwelling
  • less than 19 years old
  • pregnant
  • end-stage medical conditions with limited life expectancy
  • no access to telephone
  • does not speak english,
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Monika M. Safford, Professor, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02538055    
Other Study ID Numbers: R18HS019239 ( U.S. AHRQ Grant/Contract )
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will stay at UAB
Keywords provided by Monika M. Safford, Weill Medical College of Cornell University:
Community Health Workers
Diabetes Mellitus
Chronic Pain
Additional relevant MeSH terms:
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Diabetes Mellitus
Chronic Pain
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pain
Neurologic Manifestations