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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
230
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.
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.
Glycated hemoglobin (A1c)
fingerstick, point of care a1c test
Time frame: change in A1c in 3 months
Blood pressure
measured using digital automated blood pressure monitor
Time frame: Change in blood pressure measure in 3 months
Functional status (WOMAC)
Assessed using the the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: change in functional status in 3 months
Quality of Life (SF12)
self report using the Short form-12 (SF12)
Time frame: Change in quality of life measures at 3 months
Pain (McGill Pain Questionnaire, ICOAP)
self report using the following measures: McGill Pain Questionnaire, A measure of intermittent and Constant Osteoarthritis Pain (ICOAP),
Time frame: Change in pain measures at 3 months
Body mass index (BMI)
weight measured using digital scale, height measured using stadiometer
Time frame: 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
Time frame: change in diabetes knowledge in 3 months
diabetes management self-efficacy (PDSMS)
assessed using the Perceived Diabetes Self-Management Scale (PDSMS)
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Time frame: 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
Time frame: change in pain self efficacy measures in 3 months
Patient Activation Measure (PAM-13)
assessed using the 13 item patient activation measure (PAM-13)
Time frame: change in patient activation measures in 3 months
Perceived stress (PSS10)
Assessed using the Perceived Stress Scale (PSS10)
Time frame: change in perceived stress in 3 months
Pain coping strategies (CSQ24)
assessed using the pain coping strategies questionnaire (CSQ24)
Time frame: 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)
Time frame: change in depressive symptoms in 3 months
Trust in physicians (Trust in Physicians Scale)
assessed using the Trust in Physicians Scale
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: change in the number of days of eating unhealthy foods because of pain in the past 7 days at 3 months