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

Diabetes Mellitus Clinical Trial

— Living Healthy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02538055
• Other study ID #: R18HS019239
• Status: Completed
• Phase: N/A
• First received: July 6, 2015
• Last updated: April 26, 2016
• Start date: September 2011
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Agency for Healthcare Research and Quality (AHRQ)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated hemoglobin (A1c)	fingerstick, point of care a1c test	change in A1c in 3 months	No
Primary	Blood pressure	measured using digital automated blood pressure monitor	Change in blood pressure measure in 3 months	No
Primary	Functional status (WOMAC)	Assessed using the the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	change in functional status in 3 months	No
Primary	Quality of Life (SF12)	self report using the Short form-12 (SF12)	Change in quality of life measures at 3 months	No
Secondary	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	No
Secondary	Body mass index (BMI)	weight measured using digital scale, height measured using stadiometer	change in BMI in 3 months	No
Secondary	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	No
Secondary	diabetes management self-efficacy (PDSMS)	assessed using the Perceived Diabetes Self-Management Scale (PDSMS)	change in diabetes management self efficacy measures in 3 months	No
Secondary	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	No
Secondary	Patient Activation Measure (PAM-13)	assessed using the 13 item patient activation measure (PAM-13)	change in patient activation measures in 3 months	No
Secondary	Perceived stress (PSS10)	Assessed using the Perceived Stress Scale (PSS10)	change in perceived stress in 3 months	No
Secondary	Pain coping strategies (CSQ24)	assessed using the pain coping strategies questionnaire (CSQ24)	change in pain coping strategies in 3 months	No
Secondary	Depressive symptoms (CESD-SF)	assessed using the Short Form of Center for Epidemiological Studies scale (CESD-SF)	change in depressive symptoms in 3 months	No
Secondary	Trust in physicians (Trust in Physicians Scale)	assessed using the Trust in Physicians Scale	change in trust in physicians in 3 months	No
Secondary	Medication Adherence (4-item Morisky Medication Adherence scale)	assessed using the 4-item Morisky Medication Adherence scale	change in medication adherence in 3 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No