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Diabetes MellitusLiving HealthyNCT02538055

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

A study testing Living Healthy and General Health Program in people with Diabetes Mellitus and Chronic Pain, run by Weill Medical College of Cornell University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Diabetes Mellitus, Chronic Pain
What is being tested?
Living Healthy and General Health Program
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
230 participants
Where
No sites listed yet
Study dates
Sep 2011to Jan 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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,

About this study

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.

Read the 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.

Being tested
Living Healthy, General Health Program
Keywords
Community Health Workers, Diabetes Mellitus, Chronic Pain
Medical subject headings
Diabetes Mellitus, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Living HealthyBehavioural

    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 ProgramBehavioural

    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.

Study groups in NCT02538055
Study groupRoleWhat they receive
General Health ProgramPlacebo comparatorParticipants 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.
Receives: Behavioral: General Health Program
Living Healthy ProgramExperimentalParticipants 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.
Receives: Behavioral: Living Healthy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycated hemoglobin (A1c)

    fingerstick, point of care a1c test

    Measured: change in A1c in 3 months

  2. Blood pressure

    measured using digital automated blood pressure monitor

    Measured: Change in blood pressure measure in 3 months

  3. Functional status (WOMAC)

    Assessed using the the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Measured: change in functional status in 3 months

  4. Quality of Life (SF12)

    self report using the Short form-12 (SF12)

    Measured: Change in quality of life measures at 3 months

Secondary outcomes (19)

  1. Pain (McGill Pain Questionnaire, ICOAP)

    self report using the following measures: McGill Pain Questionnaire, A measure of intermittent and Constant Osteoarthritis Pain (ICOAP),

    Measured: Change in pain measures at 3 months

  2. Body mass index (BMI)

    weight measured using digital scale, height measured using stadiometer

    Measured: change in BMI in 3 months

  3. 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

    Measured: change in diabetes knowledge in 3 months

  4. diabetes management self-efficacy (PDSMS)

    assessed using the Perceived Diabetes Self-Management Scale (PDSMS)

    Measured: change in diabetes management self efficacy measures in 3 months

  5. Self efficacy in arthritis pain (Arthritis Self-Efficacy Scale)

    assessed using the Pain Self Efficacy Subscale of the Arthritis Self-Efficacy Scale

    Measured: change in pain self efficacy measures in 3 months

  6. Patient Activation Measure (PAM-13)

    assessed using the 13 item patient activation measure (PAM-13)

    Measured: change in patient activation measures in 3 months

  7. Perceived stress (PSS10)

    Assessed using the Perceived Stress Scale (PSS10)

    Measured: change in perceived stress in 3 months

  8. Pain coping strategies (CSQ24)

    assessed using the pain coping strategies questionnaire (CSQ24)

    Measured: change in pain coping strategies in 3 months

  9. Depressive symptoms (CESD-SF)

    assessed using the Short Form of Center for Epidemiological Studies scale (CESD-SF)

    Measured: change in depressive symptoms in 3 months

  10. Trust in physicians (Trust in Physicians Scale)

    assessed using the Trust in Physicians Scale

    Measured: change in trust in physicians in 3 months

  11. Medication Adherence (4-item Morisky Medication Adherence scale)

    assessed using the 4-item Morisky Medication Adherence scale

    Measured: change in medication adherence in 3 months

  12. 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)

    Measured: change in usual daily activity at 3 months

  13. 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)

    Measured: change in days of intense exercise at 3 months

  14. 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)

    Measured: change in days of walking for exercise at 3 months

  15. 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.

    Measured: change exercising when in pain at 3 months

  16. Physical Activity - perception of physical activity compared to others

    participant self report of activity levels compared to others their age

    Measured: change in perception of physical activity at 3 months

  17. 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

    Measured: change in the number of days of eating high fat foods at 3 months

  18. 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

    Measured: change in the number of days of having a second serving at a meal in the past 7 days

  19. 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

    Measured: change in the number of days of eating unhealthy foods because of pain in the past 7 days at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2015 (estimated)
  2. Study startSep 2011
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02538055
Sponsor's protocol ID
R18HS019239
Acronym
Living Healthy
Status last verified
Apr 2016
First submitted
6 Jul 2015
Last updated
28 Apr 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No: The data will stay at UAB

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.

    PubMed 33969866

  • 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.

    PubMed 31937528

Questions about this trial

What is this clinical trial studying?

A study testing Living Healthy and General Health Program in people with Diabetes Mellitus and Chronic Pain, run by Weill Medical College of Cornell University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycated hemoglobin (A1c) (time frame: change in A1c in 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02538055, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2016.

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