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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
- Conditions
- Diabetes Mellitus, 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Living Healthy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin (A1c)
fingerstick, point of care a1c test
Measured: change in A1c in 3 months
Blood pressure
measured using digital automated blood pressure monitor
Measured: Change in blood pressure measure in 3 months
Functional status (WOMAC)
Assessed using the the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: change in functional status in 3 months
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)
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
Body mass index (BMI)
weight measured using digital scale, height measured using stadiometer
Measured: 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
Measured: change in diabetes knowledge in 3 months
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
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
Patient Activation Measure (PAM-13)
assessed using the 13 item patient activation measure (PAM-13)
Measured: change in patient activation measures in 3 months
Perceived stress (PSS10)
Assessed using the Perceived Stress Scale (PSS10)
Measured: change in perceived stress in 3 months
Pain coping strategies (CSQ24)
assessed using the pain coping strategies questionnaire (CSQ24)
Measured: 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)
Measured: change in depressive symptoms in 3 months
Trust in physicians (Trust in Physicians Scale)
assessed using the Trust in Physicians Scale
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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.
- First posted2 Sep 2015 (estimated)
- Study startSep 2011
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Monika M. Safford, Weill Medical College of Cornell University
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 33969866Andreae 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using CERS to Optimize Quality of Life for Persons With Diabetes and Chronic Pain
- ClinicalTrials.gov ID
- NCT02538055
- Acronym / sponsor ID
- Living Healthy / R18HS019239
- Conditions
- Diabetes Mellitus, Chronic Pain
- Keywords
- Community Health Workers, Diabetes Mellitus, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Sep 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Health Program | Placebo comparator | Behavioral: General Health ProgramParticipants 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. |
| Living Healthy Program | Experimental | Behavioral: Living HealthyParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 19 or older in age
- diagnosed with diabetes
- under the care of a doctor
- experienced chronic pain in the past month
Key exclusion criteria (6 listed)
- not community dwelling
- less than 19 years old
- pregnant
- end-stage medical conditions with limited life expectancy
- no access to telephone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Living HealthyThis 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. | Behavioural | Living Healthy Program |
| General Health ProgramParticipants 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. | Behavioural | General Health Program |
Primary outcome
Glycated hemoglobin (A1c)
Time frame: change in A1c in 3 months
fingerstick, point of care a1c test
Blood pressure
Time frame: Change in blood pressure measure in 3 months
measured using digital automated blood pressure monitor
Functional status (WOMAC)
Time frame: change in functional status in 3 months
Assessed using the the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Quality of Life (SF12)
Time frame: Change in quality of life measures at 3 months
self report using the Short form-12 (SF12)
19 secondary outcomes
Pain (McGill Pain Questionnaire, ICOAP)
Time frame: Change in pain measures at 3 months
Body mass index (BMI)
Time frame: change in BMI in 3 months
Diabetes knowledge (Spoken Knowledge in Low Literacy in Diabetes Scale)
Time frame: change in diabetes knowledge in 3 months
diabetes management self-efficacy (PDSMS)
Time frame: change in diabetes management self efficacy measures in 3 months
Self efficacy in arthritis pain (Arthritis Self-Efficacy Scale)
Time frame: change in pain self efficacy measures in 3 months
Patient Activation Measure (PAM-13)
Time frame: change in patient activation measures in 3 months
Perceived stress (PSS10)
Time frame: change in perceived stress in 3 months
Pain coping strategies (CSQ24)
Time frame: change in pain coping strategies in 3 months
Depressive symptoms (CESD-SF)
Time frame: change in depressive symptoms in 3 months
Trust in physicians (Trust in Physicians Scale)
Time frame: change in trust in physicians in 3 months
Medication Adherence (4-item Morisky Medication Adherence scale)
Time frame: change in medication adherence in 3 months
Physical activity - usual daily activity
Time frame: change in usual daily activity at 3 months
Physical activity - number of days engaged in intense exercise in the past 7 days
Time frame: change in days of intense exercise at 3 months
Physical activity - number of days walked for exercise in the past 7 days
Time frame: change in days of walking for exercise at 3 months
Physical activity - exercising when in pain questions
Time frame: change exercising when in pain at 3 months
Physical Activity - perception of physical activity compared to others
Time frame: change in perception of physical activity at 3 months
Diet - days eating high fat foods in the past 7 days
Time frame: 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
Time frame: 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
Time frame: change in the number of days of eating unhealthy foods because of pain in the past 7 days at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- Derived from this study: PubMed 33969866Andreae 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.
- Derived from this study: PubMed 31937528Andreae 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.
- Individual participant dataSharing planned: No. The data will stay at UAB
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.