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

NCT02538055 | Completed

• 1 other identifier: R18HS019239
• Study Type: interventional
• Target: 230
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus; Chronic Pain

Keywords

Community Health Workers; Diabetes Mellitus; Chronic Pain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (19)

• Pain (McGill Pain Questionnaire, ICOAP)

  Change in pain measures at 3 months

• Body mass index (BMI)

  change in BMI in 3 months

• Diabetes knowledge (Spoken Knowledge in Low Literacy in Diabetes Scale)

  change in diabetes knowledge in 3 months

• diabetes management self-efficacy (PDSMS)

  change in diabetes management self efficacy measures in 3 months

• Self efficacy in arthritis pain (Arthritis Self-Efficacy Scale)

  change in pain self efficacy measures in 3 months

Study Arms (2)

General Health Program

PLACEBO COMPARATOR

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

Living Healthy Program

EXPERIMENTAL

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

Interventions

Living Healthy BEHAVIORAL

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.

Living Healthy Program

General Health Program BEHAVIORAL

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.

General Health Program

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

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

Related Publications (2)

• 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.

  PMID: 33969866 DERIVED

• 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.

  PMID: 31937528 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Chronic Pain

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: September 2, 2015
• Study Start: September 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: April 28, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share