Chronic Pain, Diabetes Mellitus
Conditions
Keywords
Community Health Workers, Diabetes Mellitus, Chronic Pain
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.
Interventions
BEHAVIORALLiving 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.
BEHAVIORALGeneral 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.
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| 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) |
| 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 |
| Depressive symptoms (CESD-SF) | change in depressive symptoms in 3 months | assessed using the Short Form of Center for Epidemiological Studies scale (CESD-SF) |
| 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 |
| 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), |
Outcome results
None listed