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

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Chronic Pain
• Interventions: Behavioral: General Health Program; Behavioral: Living Healthy

• Registration Number: NCT02538055
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2015-07-06
• Study First Submitted QC: 2015-08-28
• Study First Posted: 2015-09-02
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-26
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

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

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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,

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General Health Program	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.
Living Healthy Program	Living Healthy	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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