Using CERS to Optimize Quality of Life for Persons With Diabetes and Chronic Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Using CERS to Optimize Quality of Life for Persons With Diabetes and Chronic Pain

Conditions
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Diabetes Mellitus, Chronic Pain

Intervention / Treatment
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* Behavioral: Living Healthy
* Behavioral: General Health Program


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: General Health Program<br>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<br>* 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.<br>|
| Experimental: Living Healthy Program<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated hemoglobin (A1c) | fingerstick, point of care a1c test | change in A1c in 3 months | 
| Blood pressure | measured using digital automated blood pressure monitor | Change in blood pressure measure in 3 months | 
| Functional status (WOMAC) | Assessed using the the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | change in functional status in 3 months | 
| Quality of Life (SF12) | self report using the Short form-12 (SF12) | Change in quality of life measures at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (McGill Pain Questionnaire, ICOAP) | self report using the following measures: McGill Pain Questionnaire, A measure of intermittent and Constant Osteoarthritis Pain (ICOAP), | Change in pain measures at 3 months | 
| Body mass index (BMI) | weight measured using digital scale, height measured using stadiometer | change in BMI in 3 months | 
| Diabetes knowledge (Spoken Knowledge in Low Literacy in Diabetes Scale) | assessed using a modified version of the Spoken Knowledge in Low Literacy in Diabetes Scale | change in diabetes knowledge in 3 months | 
| diabetes management self-efficacy (PDSMS) | assessed using the Perceived Diabetes Self-Management Scale (PDSMS) | change in diabetes management self efficacy measures in 3 months | 
| Self efficacy in arthritis pain (Arthritis Self-Efficacy Scale) | assessed using the Pain Self Efficacy Subscale of the Arthritis Self-Efficacy Scale | change in pain self efficacy measures in 3 months | 
| Patient Activation Measure (PAM-13) | assessed using the 13 item patient activation measure (PAM-13) | change in patient activation measures in 3 months | 
| Perceived stress (PSS10) | Assessed using the Perceived Stress Scale (PSS10) | change in perceived stress in 3 months | 
| Pain coping strategies (CSQ24) | assessed using the pain coping strategies questionnaire (CSQ24) | change in pain coping strategies in 3 months | 
| Depressive symptoms (CESD-SF) | assessed using the Short Form of Center for Epidemiological Studies scale (CESD-SF) | change in depressive symptoms in 3 months | 
| Trust in physicians (Trust in Physicians Scale) | assessed using the Trust in Physicians Scale | change in trust in physicians in 3 months | 
| Medication Adherence (4-item Morisky Medication Adherence scale) | assessed using the 4-item Morisky Medication Adherence scale | change in medication adherence in 3 months | 
| Physical activity - usual daily activity | 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) | change in usual daily activity at 3 months | 
| Physical activity - number of days engaged in intense exercise in the past 7 days | participant self report of number of days in the past week engaged in intense exercise (0-7 days) | change in days of intense exercise at 3 months | 
| Physical activity - number of days walked for exercise in the past 7 days | participant self report of number of days in the past week walked for exercise (0-7) | change in days of walking for exercise at 3 months | 
| Physical activity - exercising when in pain questions | 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. | change exercising when in pain at 3 months | 
| Physical Activity - perception of physical activity compared to others | participant self report of activity levels compared to others their age | change in perception of physical activity at 3 months | 
| Diet - days eating high fat foods in the past 7 days | participant self report of days in the past 7 days of eating high-fat foods | change in the number of days of eating high fat foods at 3 months | 
| Diet - 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 | change in the number of days of having a second serving at a meal in the past 7 days | 
| Diet - eating unhealthy foods because of pain in the past 7 days | participant self report of days in the past 7 days of eating unhealthy foods because of experiencing pain | change in the number of days of eating unhealthy foods because of pain in the past 7 days at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community Health Workers, Diabetes Mellitus, Chronic Pain