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

Primary Purpose

Diabetes Mellitus, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Living Healthy
General Health Program
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Community Health Workers, Diabetes Mellitus, Chronic Pain

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    General Health Program

    Living Healthy Program

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Glycated hemoglobin (A1c)
    fingerstick, point of care a1c test
    Blood pressure
    measured using digital automated blood pressure monitor
    Functional status (WOMAC)
    Assessed using the the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
    Quality of Life (SF12)
    self report using the Short form-12 (SF12)

    Secondary Outcome Measures

    Pain (McGill Pain Questionnaire, ICOAP)
    self report using the following measures: McGill Pain Questionnaire, A measure of intermittent and Constant Osteoarthritis Pain (ICOAP),
    Body mass index (BMI)
    weight measured using digital scale, height measured using stadiometer
    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
    diabetes management self-efficacy (PDSMS)
    assessed using the Perceived Diabetes Self-Management Scale (PDSMS)
    Self efficacy in arthritis pain (Arthritis Self-Efficacy Scale)
    assessed using the Pain Self Efficacy Subscale of the Arthritis Self-Efficacy Scale
    Patient Activation Measure (PAM-13)
    assessed using the 13 item patient activation measure (PAM-13)
    Perceived stress (PSS10)
    Assessed using the Perceived Stress Scale (PSS10)
    Pain coping strategies (CSQ24)
    assessed using the pain coping strategies questionnaire (CSQ24)
    Depressive symptoms (CESD-SF)
    assessed using the Short Form of Center for Epidemiological Studies scale (CESD-SF)
    Trust in physicians (Trust in Physicians Scale)
    assessed using the Trust in Physicians Scale
    Medication Adherence (4-item Morisky Medication Adherence scale)
    assessed using the 4-item Morisky Medication Adherence scale
    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)
    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)
    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)
    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.
    Physical Activity - perception of physical activity compared to others
    participant self report of activity levels compared to others their age
    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
    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
    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

    Full Information

    First Posted
    July 6, 2015
    Last Updated
    April 26, 2016
    Sponsor
    Weill Medical College of Cornell University
    Collaborators
    Agency for Healthcare Research and Quality (AHRQ)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02538055
    Brief Title
    Using CERS to Optimize Quality of Life for Persons With Diabetes and Chronic Pain
    Acronym
    Living Healthy
    Official Title
    Using CERS to Optimize Quality of Life for Persons With Diabetes and Chronic Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2011 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Weill Medical College of Cornell University
    Collaborators
    Agency for Healthcare Research and Quality (AHRQ)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Chronic Pain
    Keywords
    Community Health Workers, Diabetes Mellitus, Chronic Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    230 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    General Health Program
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    Living Healthy Program
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Living Healthy
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    General Health Program
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Glycated hemoglobin (A1c)
    Description
    fingerstick, point of care a1c test
    Time Frame
    change in A1c in 3 months
    Title
    Blood pressure
    Description
    measured using digital automated blood pressure monitor
    Time Frame
    Change in blood pressure measure in 3 months
    Title
    Functional status (WOMAC)
    Description
    Assessed using the the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
    Time Frame
    change in functional status in 3 months
    Title
    Quality of Life (SF12)
    Description
    self report using the Short form-12 (SF12)
    Time Frame
    Change in quality of life measures at 3 months
    Secondary Outcome Measure Information:
    Title
    Pain (McGill Pain Questionnaire, ICOAP)
    Description
    self report using the following measures: McGill Pain Questionnaire, A measure of intermittent and Constant Osteoarthritis Pain (ICOAP),
    Time Frame
    Change in pain measures at 3 months
    Title
    Body mass index (BMI)
    Description
    weight measured using digital scale, height measured using stadiometer
    Time Frame
    change in BMI in 3 months
    Title
    Diabetes knowledge (Spoken Knowledge in Low Literacy in Diabetes Scale)
    Description
    assessed using a modified version of the Spoken Knowledge in Low Literacy in Diabetes Scale
    Time Frame
    change in diabetes knowledge in 3 months
    Title
    diabetes management self-efficacy (PDSMS)
    Description
    assessed using the Perceived Diabetes Self-Management Scale (PDSMS)
    Time Frame
    change in diabetes management self efficacy measures in 3 months
    Title
    Self efficacy in arthritis pain (Arthritis Self-Efficacy Scale)
    Description
    assessed using the Pain Self Efficacy Subscale of the Arthritis Self-Efficacy Scale
    Time Frame
    change in pain self efficacy measures in 3 months
    Title
    Patient Activation Measure (PAM-13)
    Description
    assessed using the 13 item patient activation measure (PAM-13)
    Time Frame
    change in patient activation measures in 3 months
    Title
    Perceived stress (PSS10)
    Description
    Assessed using the Perceived Stress Scale (PSS10)
    Time Frame
    change in perceived stress in 3 months
    Title
    Pain coping strategies (CSQ24)
    Description
    assessed using the pain coping strategies questionnaire (CSQ24)
    Time Frame
    change in pain coping strategies in 3 months
    Title
    Depressive symptoms (CESD-SF)
    Description
    assessed using the Short Form of Center for Epidemiological Studies scale (CESD-SF)
    Time Frame
    change in depressive symptoms in 3 months
    Title
    Trust in physicians (Trust in Physicians Scale)
    Description
    assessed using the Trust in Physicians Scale
    Time Frame
    change in trust in physicians in 3 months
    Title
    Medication Adherence (4-item Morisky Medication Adherence scale)
    Description
    assessed using the 4-item Morisky Medication Adherence scale
    Time Frame
    change in medication adherence in 3 months
    Title
    Physical activity - usual daily activity
    Description
    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)
    Time Frame
    change in usual daily activity at 3 months
    Title
    Physical activity - number of days engaged in intense exercise in the past 7 days
    Description
    participant self report of number of days in the past week engaged in intense exercise (0-7 days)
    Time Frame
    change in days of intense exercise at 3 months
    Title
    Physical activity - number of days walked for exercise in the past 7 days
    Description
    participant self report of number of days in the past week walked for exercise (0-7)
    Time Frame
    change in days of walking for exercise at 3 months
    Title
    Physical activity - exercising when in pain questions
    Description
    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.
    Time Frame
    change exercising when in pain at 3 months
    Title
    Physical Activity - perception of physical activity compared to others
    Description
    participant self report of activity levels compared to others their age
    Time Frame
    change in perception of physical activity at 3 months
    Title
    Diet - days eating high fat foods in the past 7 days
    Description
    participant self report of days in the past 7 days of eating high-fat foods
    Time Frame
    change in the number of days of eating high fat foods at 3 months
    Title
    Diet - having a second serving at a meal in the past 7 days
    Description
    participant self report of days in the past 7 days of having a second serving at a meal in the past 7 days
    Time Frame
    change in the number of days of having a second serving at a meal in the past 7 days
    Title
    Diet - eating unhealthy foods because of pain in the past 7 days
    Description
    participant self report of days in the past 7 days of eating unhealthy foods because of experiencing pain
    Time Frame
    change in the number of days of eating unhealthy foods because of pain in the past 7 days at 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    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,

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The data will stay at UAB
    Citations:
    PubMed Identifier
    33969866
    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.
    Results Reference
    derived
    PubMed Identifier
    31937528
    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.
    Results Reference
    derived

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

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