Using CERS to Optimize Quality of Life for Persons With Diabetes and Chronic Pain (Living Healthy)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Chronic Pain
• Intervention / Treatment: Behavioral: General Health Program; Behavioral: Living Healthy

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.

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Behavioral: 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.
Experimental: Living Healthy Program; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: July 6, 2015
• First Submitted That Met QC Criteria: August 28, 2015
• First Posted (Estimate): September 2, 2015

Study Record Updates

• Last Update Posted (Estimate): April 28, 2016
• Last Update Submitted That Met QC Criteria: April 26, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Chronic Pain; Diabetes Mellitus; Community Health Workers
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Pain; Neurologic Manifestations; Endocrine System Diseases; Diabetes Mellitus; Chronic Pain
• Other Study ID Numbers: R18HS019239 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will stay at UAB