Diabetes Type 2REDEEMNCT00714441
Reducing Distress and Improving Self-Care in Diabetes
A study testing Lifestyle and Activities Education Program (LEAP-AHEAD), Computer Automated Self-Management (CASM) and Computer Automated Self-Management and Problem Solving Therapy (CAPS) in people with Diabetes Type 2, run by University of California, San Francisco at 1 site in United States.
Trial summary
To date, there have been few practical, evidenced based interventions that are directed at patients with Type II Diabetes who are experiencing depressed and/or emotional distress in primary care settings. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Lifestyle and Activities Education Program (LEAP-AHEAD), Computer Automated Self-Management (CASM) and Computer Automated Self-Management and Problem Solving Therapy (CAPS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Nov 2011
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of type 2 diabetes (confirmed using the Wellborn criteria for a minimum of 12 months)
- Be between 21 and 75 years of age
- Speak and read Spanish or English fluently
- In addition, based on the telephone screening, patients will have to display a high level of diabetes distress and a deficit in at least one of three self-management areas (diet, physical activity, medication adherence). This is defined as having an average item score > 3.0 on 2 items from the regimen distress and emotional burden sub scale of the DDS and indication of problems in management on at least one scale of the SDSCA (i.e., endorsing having a healthy eating plan on less than 5 days/week, 30 minutes physical activity less than 5 days/week, or forget to take medicines more than 1 day/week).
- Have access to the internet
Who cannot join
- Have major disabilities or severe disorders (MI in the last 12 months, psychosis, on end-stage dialysis, dementia)
- Have current MDD (based on the PHQ8).
Trial locations and contacts
1 site in 1 country.
United States1 site
UC San Francisco, Family and Community Medicine Dept.
San Francisco, California, 94143
About this study
To date, there have been few practical, evidenced based interventions that are directed at patients with Type II Diabetes who are experiencing depressed and/or emotional distress in primary care settings. This study will (1) combine two existing, evidenced-based, interventions (a computer automated, diabetes specific self-management program (CASM) vs. a self-care program plus a live problem solving distress-reduction program (CAPS) vs. a lifestyle and activities education program (LEAP-AHEAD)) into a practical, 3-arm clinical trial with a highly distressed multi-ethnic patient sample, and (2) evaluate the intervention using the RE-AIM framework, sharing the results through a comprehensive dissemination package.
Hypothesis 1: The combined CASM and CAPS arms will be superior to the LEAP-AHEAD group on the primary outcomes at follow-up.
Hypothesis 2: The CAPS arm will be superior to the CASM arm on primary outcomes at follow-up.
- Conditions
- Diabetes Type 2
- Being tested
- Lifestyle and Activities Education Program (LEAP-AHEAD), Computer Automated Self-Management (CASM), Computer Automated Self-Management and Problem Solving Therapy (CAPS)
- Keywords
- Diabetes Type 2, Distress, Problem Solving Therapy, Computer Automated Self-Management (CASM)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle and Activities Education Program (LEAP-AHEAD)Behavioural
Patients in the LEAP-AHEAD Program arm will be shown a 40-minute interactional DVD and given the Healthy Habits Health Risk Appraisal, at baseline and 20 weeks that asks questions about diabetes self care practices and other health behaviors and gives recommendations in those areas. A score sheet based on the participant's responses will be left with the participant. At intervals from 0 to 44 weeks, patients will receive emailed informational pamphlets on diabetes and its complications, along with live telephone calls to answer any questions and check-in.
Computer Automated Self-Management (CASM)Behavioural
CASM is a live and computer-assisted, low intensity, automated web and telephony based program that is directed at enhancing and sustaining diabetes self-management behavior over time. It provides education on the importance of healthy eating, physical activity and medication taking, and then asks patients to select an area for behavior change. At baseline patients will have a 45 minutes home visit to help them set goals and familiarize them with the website. A booster session is given at 20 weeks. Patients receive 8 ive phone calls over 12 months to support behavior change efforts.
Computer Automated Self-Management and Problem Solving Therapy (CAPS)Behavioural
Patients in the CAPS program receive all of the protocol included in the CASM program, and in addition receive a Problem Solving program. Problem solving is a process by which an individual attempts an adaptive solution to stressful, real life problem(s). At baseline there is a 45 minute home visit where the Counselor will introduce the patient to CASM and will go on to teach the patient about diabetes distress and PST. They will then generate a list of distress-related problems to teach the steps of PST. The steps of PST are: problem definition, goal setting, brain storming, decision making, action planning, and solution review. At 20 weeks there will be a booster session. Patients receive 8 live phone calls over 12 months to support behavior change efforts.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Computer Automated Self-Management (CASM). Please see description below for CASM. Receives: Behavioral: Computer Automated Self-Management (CASM) |
| 3 | Active comparator | Computer Automated Self-Management and Problem Solving Therapy (CAPS). Please see descriptions below for CAPS (also refer to CASM with is included in the CAPS program). Receives: Behavioral: Computer Automated Self-Management (CASM); Behavioral: Computer Automated Self-Management and Problem Solving Therapy (CAPS) |
| 1 | Active comparator | Lifestyle and Activities Education Program (LEAP-AHEAD). Please see description below for LEAP-AHEAD. Receives: Behavioral: Lifestyle and Activities Education Program (LEAP-AHEAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet. Starting the Conversation is a 9 items measure of eating patterns (including 2 items from the NCI Fruit and Vegetable Screener). NCI Percent Energy from Fat Screen (PFAT) contains 17 items concerning frequency of intake for 15 food groups.
Measured: Baseline, 16 weeks, and 12 months
Physical Activity. The CHAMPS (28 items) will be used to measure physical activity.
Measured: Baseline, 16 weeks, and 12 months
Medication Adherence. Medication taking will be assessed by the Hill-Bone Medication Adherence scale. Questions will also cover smoking and alcohol use.
Measured: Baseline, 16 weeks, and 12 months
Distress. Patient distress will be assessed across several measures including: the 20-item CES-D, the 17-item DDS, the PHQ8, and screening items from the SCID to rule out psychosis.
Measured: Baseline, 16 weeks, and 12 months
Secondary outcomes (4)
HbA1C
Measured: Baseline, 16 weeks, and 12 months
Blood Pressure
Measured: Baseline, 16 weeks, and 12 months
Fasting glucose
Measured: Baseline, 16 weeks, and 12 months
Lipids
Measured: Baseline, 16 weeks, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence Fisher, Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714441
- Sponsor's protocol ID
- 2R01DK061937-05A1
- Other IDs
- 2R01DK061937-05A1
- Acronym
- REDEEM
- Status last verified
- Apr 2012
- First submitted
- 9 Jul 2008
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med. 2008 May-Jun;6(3):246-52. doi: 10.1370/afm.842.
PubMed 18474888Fisher L, Skaff MM, Mullan JT, Arean P, Mohr D, Masharani U, Glasgow R, Laurencin G. Clinical depression versus distress among patients with type 2 diabetes: not just a question of semantics. Diabetes Care. 2007 Mar;30(3):542-8. doi: 10.2337/dc06-1614.
PubMed 17327318Glasgow RE, Fisher L, Skaff M, Mullan J, Toobert DJ. Problem solving and diabetes self-management: investigation in a large, multiracial sample. Diabetes Care. 2007 Jan;30(1):33-7. doi: 10.2337/dc06-1390.
PubMed 17192329Arean PA, Perri MG, Nezu AM, Schein RL, Christopher F, Joseph TX. Comparative effectiveness of social problem-solving therapy and reminiscence therapy as treatments for depression in older adults. J Consult Clin Psychol. 1993 Dec;61(6):1003-10. doi: 10.1037//0022-006x.61.6.1003.
PubMed 8113478Glasgow RE, Klesges LM, Dzewaltowski DA, Estabrooks PA, Vogt TM. Evaluating the impact of health promotion programs: using the RE-AIM framework to form summary measures for decision making involving complex issues. Health Educ Res. 2006 Oct;21(5):688-94. doi: 10.1093/her/cyl081. Epub 2006 Aug 31.
PubMed 16945984Glasgow RE, Strycker LA, King DK, Toobert DJ, Rahm AK, Jex M, Nutting PA. Robustness of a computer-assisted diabetes self-management intervention across patient characteristics, healthcare settings, and intervention staff. Am J Manag Care. 2006 Mar;12(3):137-45.
PubMed 16524346Fisher L, Mullan JT, Skaff MM, Glasgow RE, Arean P, Hessler D. Predicting diabetes distress in patients with Type 2 diabetes: a longitudinal study. Diabet Med. 2009 Jun;26(6):622-7. doi: 10.1111/j.1464-5491.2009.02730.x.
PubMed 19538238Cashmore BA, Cooper TE, Evangelidis NM, Green SC, Lopez-Vargas P, Tunnicliffe DJ. Education programmes for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD007374. doi: 10.1002/14651858.CD007374.pub3.
PubMed 39171639Hessler D, Fisher L, Glasgow RE, Strycker LA, Dickinson LM, Arean PA, Masharani U. Reductions in regimen distress are associated with improved management and glycemic control over time. Diabetes Care. 2014;37(3):617-24. doi: 10.2337/dc13-0762. Epub 2013 Oct 29.
PubMed 24170750Fisher L, Hessler D, Glasgow RE, Arean PA, Masharani U, Naranjo D, Strycker LA. REDEEM: a pragmatic trial to reduce diabetes distress. Diabetes Care. 2013 Sep;36(9):2551-8. doi: 10.2337/dc12-2493. Epub 2013 Jun 4.
PubMed 23735726
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Distress and Improving Self-Care in Diabetes
- ClinicalTrials.gov ID
- NCT00714441
- Acronym / sponsor ID
- REDEEM / 2R01DK061937-05A1
- Conditions
- Diabetes Type 2
- Keywords
- Diabetes Type 2, Distress, Problem Solving Therapy, Computer Automated Self-Management (CASM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 14 Jul 2008 (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.
To date, there have been few practical, evidenced based interventions that are directed at patients with Type II Diabetes who are experiencing depressed and/or emotional distress in primary care settings. This study will (1) combine two existing, evidenced-based, interventions (a computer automated, diabetes specific self-management program (CASM) vs. a self-care program plus a live problem solving distress-reduction program (CAPS) vs. a lifestyle and activities education program (LEAP-AHEAD)) into a practical, 3-arm clinical trial with a highly distressed multi-ethnic patient sample, and (2) evaluate the intervention using the RE-AIM framework, sharing the results through a comprehensive dissemination package.
Hypothesis 1: The combined CASM and CAPS arms will be superior to the LEAP-AHEAD group on the primary outcomes at follow-up.
Hypothesis 2: The CAPS arm will be superior to the CASM arm on primary outcomes at follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Behavioral: Computer Automated Self-Management (CASM)Computer Automated Self-Management (CASM). Please see description below for CASM. |
| 3 | Active comparator | Behavioral: Computer Automated Self-Management (CASM), Behavioral: Computer Automated Self-Management and Problem Solving Therapy (CAPS)Computer Automated Self-Management and Problem Solving Therapy (CAPS). Please see descriptions below for CAPS (also refer to CASM with is included in the CAPS program). |
| 1 | Active comparator | Behavioral: Lifestyle and Activities Education Program (LEAP-AHEAD)Lifestyle and Activities Education Program (LEAP-AHEAD). Please see description below for LEAP-AHEAD. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a diagnosis of type 2 diabetes (confirmed using the Wellborn criteria for a minimum of 12 months)
- Be between 21 and 75 years of age
- Speak and read Spanish or English fluently
- In addition, based on the telephone screening, patients will have to display a high level of diabetes distress and a deficit in at least one of three self-management areas (diet, physical activity, medication adherence). This is defined as having an average item score > 3.0 on 2 items from the regimen distress and emotional burden sub scale of the DDS and indication of problems in management on at least one scale of the SDSCA (i.e., endorsing having a healthy eating plan on less than 5 days/week, 30 minutes physical activity less than 5 days/week, or forget to take medicines more than 1 day/week).
- Have access to the internet
Key exclusion criteria (2 listed)
- Have major disabilities or severe disorders (MI in the last 12 months, psychosis, on end-stage dialysis, dementia)
- Have current MDD (based on the PHQ8).
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 |
|---|---|---|
| Lifestyle and Activities Education Program (LEAP-AHEAD)Patients in the LEAP-AHEAD Program arm will be shown a 40-minute interactional DVD and given the Healthy Habits Health Risk Appraisal, at baseline and 20 weeks that asks questions about diabetes self care practices and other health behaviors and gives recommendations in those areas. A score sheet based on the participant's responses will be left with the participant. At intervals from 0 to 44 weeks, patients will receive emailed informational pamphlets on diabetes and its complications, along with live telephone calls to answer any questions and check-in. | Behavioural | 1 |
| Computer Automated Self-Management (CASM)CASM is a live and computer-assisted, low intensity, automated web and telephony based program that is directed at enhancing and sustaining diabetes self-management behavior over time. It provides education on the importance of healthy eating, physical activity and medication taking, and then asks patients to select an area for behavior change. At baseline patients will have a 45 minutes home visit to help them set goals and familiarize them with the website. A booster session is given at 20 weeks. Patients receive 8 ive phone calls over 12 months to support behavior change efforts. | Behavioural | 2, 3 |
| Computer Automated Self-Management and Problem Solving Therapy (CAPS)Patients in the CAPS program receive all of the protocol included in the CASM program, and in addition receive a Problem Solving program. Problem solving is a process by which an individual attempts an adaptive solution to stressful, real life problem(s). At baseline there is a 45 minute home visit where the Counselor will introduce the patient to CASM and will go on to teach the patient about diabetes distress and PST. They will then generate a list of distress-related problems to teach the steps of PST. The steps of PST are: problem definition, goal setting, brain storming, decision making, action planning, and solution review. At 20 weeks there will be a booster session. Patients receive 8 live phone calls over 12 months to support behavior change efforts. | Behavioural | 3 |
Primary outcome
Diet. Starting the Conversation is a 9 items measure of eating patterns (including 2 items from the NCI Fruit and Vegetable Screener). NCI Percent Energy from Fat Screen (PFAT) contains 17 items concerning frequency of intake for 15 food groups.
Time frame: Baseline, 16 weeks, and 12 months
Physical Activity. The CHAMPS (28 items) will be used to measure physical activity.
Time frame: Baseline, 16 weeks, and 12 months
Medication Adherence. Medication taking will be assessed by the Hill-Bone Medication Adherence scale. Questions will also cover smoking and alcohol use.
Time frame: Baseline, 16 weeks, and 12 months
Distress. Patient distress will be assessed across several measures including: the 20-item CES-D, the 17-item DDS, the PHQ8, and screening items from the SCID to rule out psychosis.
Time frame: Baseline, 16 weeks, and 12 months
4 secondary outcomes
HbA1C
Time frame: Baseline, 16 weeks, and 12 months
Blood Pressure
Time frame: Baseline, 16 weeks, and 12 months
Fasting glucose
Time frame: Baseline, 16 weeks, and 12 months
Lipids
Time frame: Baseline, 16 weeks, and 12 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 19 Apr 2012.
- Background: PubMed 18474888Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med. 2008 May-Jun;6(3):246-52. doi: 10.1370/afm.842.
- Background: PubMed 17327318Fisher L, Skaff MM, Mullan JT, Arean P, Mohr D, Masharani U, Glasgow R, Laurencin G. Clinical depression versus distress among patients with type 2 diabetes: not just a question of semantics. Diabetes Care. 2007 Mar;30(3):542-8. doi: 10.2337/dc06-1614.
- Background: PubMed 17192329Glasgow RE, Fisher L, Skaff M, Mullan J, Toobert DJ. Problem solving and diabetes self-management: investigation in a large, multiracial sample. Diabetes Care. 2007 Jan;30(1):33-7. doi: 10.2337/dc06-1390.
- Background: PubMed 8113478Arean PA, Perri MG, Nezu AM, Schein RL, Christopher F, Joseph TX. Comparative effectiveness of social problem-solving therapy and reminiscence therapy as treatments for depression in older adults. J Consult Clin Psychol. 1993 Dec;61(6):1003-10. doi: 10.1037//0022-006x.61.6.1003.
- Background: PubMed 16945984Glasgow RE, Klesges LM, Dzewaltowski DA, Estabrooks PA, Vogt TM. Evaluating the impact of health promotion programs: using the RE-AIM framework to form summary measures for decision making involving complex issues. Health Educ Res. 2006 Oct;21(5):688-94. doi: 10.1093/her/cyl081. Epub 2006 Aug 31.
- Background: PubMed 16524346Glasgow RE, Strycker LA, King DK, Toobert DJ, Rahm AK, Jex M, Nutting PA. Robustness of a computer-assisted diabetes self-management intervention across patient characteristics, healthcare settings, and intervention staff. Am J Manag Care. 2006 Mar;12(3):137-45.
- Background: PubMed 19538238Fisher L, Mullan JT, Skaff MM, Glasgow RE, Arean P, Hessler D. Predicting diabetes distress in patients with Type 2 diabetes: a longitudinal study. Diabet Med. 2009 Jun;26(6):622-7. doi: 10.1111/j.1464-5491.2009.02730.x.
- Derived from this study: PubMed 39171639Cashmore BA, Cooper TE, Evangelidis NM, Green SC, Lopez-Vargas P, Tunnicliffe DJ. Education programmes for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD007374. doi: 10.1002/14651858.CD007374.pub3.
- Derived from this study: PubMed 24170750Hessler D, Fisher L, Glasgow RE, Strycker LA, Dickinson LM, Arean PA, Masharani U. Reductions in regimen distress are associated with improved management and glycemic control over time. Diabetes Care. 2014;37(3):617-24. doi: 10.2337/dc13-0762. Epub 2013 Oct 29.
- Derived from this study: PubMed 23735726Fisher L, Hessler D, Glasgow RE, Arean PA, Masharani U, Naranjo D, Strycker LA. REDEEM: a pragmatic trial to reduce diabetes distress. Diabetes Care. 2013 Sep;36(9):2551-8. doi: 10.2337/dc12-2493. Epub 2013 Jun 4.
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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.
Lawrence Fisher, Ph.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle and Activities Education Program (LEAP-AHEAD), Computer Automated Self-Management (CASM) and Computer Automated Self-Management and Problem Solving Therapy (CAPS) in people with Diabetes Type 2, run by University of California, San Francisco at 1 site in United States.
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 5 inclusion and 2 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 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Diet. Starting the Conversation is a 9 items measure of eating patterns (including 2 items from the NCI Fruit and Vegetable Screener). NCI Percent Energy from Fat Screen (PFAT) contains 17 items concerning frequency of intake for 15 food groups. (time frame: Baseline, 16 weeks, and 12 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 NCT00714441, which also lists 10 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 19 Apr 2012.