Clinical trial NCT02538055: Using CERS to Optimize Quality of Life for Persons With Diabetes and Chronic Pain
Official title: Using CERS to Optimize Quality of Life for Persons With Diabetes and Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Chronic Pain
Keywords: Community Health Workers
Diabetes Mellitus
Chronic Pain
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2015-09-02
Enrollment: 230
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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,

Primary outcomes:
measure: Glycated hemoglobin (A1c)
timeFrame: change in A1c in 3 months
measure: Blood pressure
timeFrame: Change in blood pressure measure in 3 months
measure: Functional status (WOMAC)
timeFrame: change in functional status in 3 months
measure: Quality of Life (SF12)
timeFrame: Change in quality of life measures at 3 months
Secondary outcomes:
measure: Pain (McGill Pain Questionnaire, ICOAP)
timeFrame: Change in pain measures at 3 months
measure: Body mass index (BMI)
timeFrame: change in BMI in 3 months
measure: Diabetes knowledge (Spoken Knowledge in Low Literacy in Diabetes Scale)
timeFrame: change in diabetes knowledge in 3 months
measure: diabetes management self-efficacy (PDSMS)
timeFrame: change in diabetes management self efficacy measures in 3 months
measure: Self efficacy in arthritis pain (Arthritis Self-Efficacy Scale)
timeFrame: change in pain self efficacy measures in 3 months
measure: Patient Activation Measure (PAM-13)
timeFrame: change in patient activation measures in 3 months
measure: Perceived stress (PSS10)
timeFrame: change in perceived stress in 3 months
measure: Pain coping strategies (CSQ24)
timeFrame: change in pain coping strategies in 3 months
measure: Depressive symptoms (CESD-SF)
timeFrame: change in depressive symptoms in 3 months
measure: Trust in physicians (Trust in Physicians Scale)
timeFrame: change in trust in physicians in 3 months
measure: Medication Adherence (4-item Morisky Medication Adherence scale)
timeFrame: change in medication adherence in 3 months
measure: Physical activity - usual daily activity
timeFrame: change in usual daily activity at 3 months
measure: Physical activity - number of days engaged in intense exercise in the past 7 days
timeFrame: change in days of intense exercise at 3 months
measure: Physical activity - number of days walked for exercise in the past 7 days
timeFrame: change in days of walking for exercise at 3 months
measure: Physical activity - exercising when in pain questions
timeFrame: change exercising when in pain at 3 months
measure: Physical Activity - perception of physical activity compared to others
timeFrame: change in perception of physical activity at 3 months
measure: Diet - days eating high fat foods in the past 7 days
timeFrame: change in the number of days of eating high fat foods at 3 months
measure: Diet - having a second serving at a meal in the past 7 days
timeFrame: change in the number of days of having a second serving at a meal in the past 7 days
measure: Diet - eating unhealthy foods because of pain in the past 7 days
timeFrame: change in the number of days of eating unhealthy foods because of pain in the past 7 days at 3 months
Other outcomes:
Locations:
Study officials:
References:
citation: Andreae SJ, Andreae LJ, Richman JS, Cherrington AL, Safford MM. Peer-delivered Cognitive Behavioral Therapy-based Intervention Reduced Depression and Stress in Community Dwelling Adults With Diabetes and Chronic Pain: A Cluster Randomized Trial. Ann Behav Med. 2021 Oct 4;55(10):970-980. doi: 10.1093/abm/kaab034.
citation: Andreae SJ, Andreae LJ, Richman JS, Cherrington AL, Safford MM. Peer-Delivered Cognitive Behavioral Training to Improve Functioning in Patients With Diabetes: A Cluster-Randomized Trial. Ann Fam Med. 2020 Jan;18(1):15-23. doi: 10.1370/afm.2469.