DiabetesNCT01106885
Effective Care Management of Depressed Diabetes Patients (The Positive Steps Study)
A study testing Medication Care Management (MCM) and Cognitive-Behavioral Therapy (CBT) in people with Diabetes and Depression, run by University of Michigan at 3 sites in United States.
Trial summary
Evaluation of telephone care management intervention designed to improve outcomes among depressed diabetes patients. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Diabetes, Depression
- What is being tested?
- Medication Care Management (MCM) and Cognitive-Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2005to Apr 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria. Patients must meet all of the following criteria:
- Active Diabetes (Type 1 \& 2)
- Diagnosis of depression
- Using hypoglycemic medications
- At least 1 outpatient visit in last 12 months
- At least 21 years old
Exclusion Criteria. Patients who have any of the following will be excluded:
- Limited life expectancy (heart failure/ on oxygen/ advanced stage cancer/ dialysis)
- End stage renal disease
- Lung cancer
- Dementia
- Bipolar
- Schizophrenia
- Can't speak English
- Memory problems
- Alcohol problems
- Illegal drug use
- Minimal depressive symptoms
- Blood pressure 180/110 or higher
- Problems with loss of consciousness
- Can't walk 10 minutes on level surface
- Not planning to get their care at study site
- PCP not affiliated with study site
- Are not on a stable regimen (change in depression Rx in last 28-30 days)
- Type 1 diabetic if diagnosed before age 15
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105
University of Michigan Health System
Ann Arbor, Michigan, 48109
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
About this study
Official title: Effective Care Management of Depressed Diabetes Patients
Evaluation of telephone care management intervention designed to improve outcomes among depressed diabetes patients.
Read the detailed description
Research Plan: 382 patients ages 21-80, including 177 women, and 123 Blacks from the Ann Arbor VA HCS, UM, and the Genesys Health Care System in Flint. Patients will be randomized to: (1) brief education about depression, diabetes self-care, and physical activity; or (2) telephone care management including antidepressant medication care management (MCM) and/or cognitive behavioral therapy (CBT). The MCM module uses a standard algorithm to identify efficacious antidepressants and promote adherence. The CBT module addresses symptoms, exercise, and communication skills.
Methods: Surveys: Patients will complete clinic-based surveys at baseline and 12-months to measure their health status, self-care, provider-patient communication, and resource use. At 4 months, they will complete a mailed questionnaire to capture short-term changes in depressive symptoms, walking, patient-provider communication, medication adherence, and quality-of-life. Physiologic Measures: At baseline and 12-months, patients' A1c and cholesterol will be measured via a fingerstick blood test. We also will measure blood pressure, height, and weight. With patients' 4-month mailed surveys, they will complete fingerstick A1c tests and return the results via mail. The blood tests are identical to those diabetes patients use to self-monitor their blood glucose. Pedometers: We will measure distance walked at baseline, 4 months, and 12 months using a pedometer. Patients will record their walk distances for one week and return the results via mail. Electronic data: Utilization and billing databases will be used to identify health service utilization (ER visits, outpatient care, hospitalizations) occurring during patients' participation and the prior 12 months. Physician feedback. At patients' 12-month assessment, the physician will complete a brief survey about the patient's communication style. All patients will provide written consent administered prior to their face-to-face screening and baseline interviews. Physician 12-month surveys about patients' communication style will be anonymous.
- Conditions
- Diabetes, Depression
- Being tested
- Medication Care Management (MCM), Cognitive-Behavioral Therapy (CBT)
- Keywords
- Diabetes, Depression, Telephone Care Management, Medication Care Management (MCM), Cognitive Behavioral Therapy (CBT)
- Medical subject headings
- Diabetes Mellitus, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Care Management (MCM)Behavioural
- Basic physical activity counseling
- Notify PCP and facilitate initiation of antidepressants
- Medication monitoring calls at 1, 2, 4, 6, 8, 10, and 12 weeks*
- 1/mo monitoring in continuation phase (mos. 4-12)*
- Report \& recommendations to PCP after each patient call
- Note: *average of 10 minutes of telephone time each (series is repeated if second antidepressant trial is needed)
Cognitive-Behavioral Therapy (CBT)Behavioural
- Notify PCP
- CBT Manual
- Weekly CBT focused counseling for 12 weeks**
- Monthly CBT in months 4-12**
- Behavioral physical activity counseling
- Report \& recommendations to PCP after each patient call
- Note: **average of 50 minutes of telephone time each
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care | No intervention | Adult patients with diabetes and depression. * Report screening results * Notify PCP of screening results (optional per patient) * PCP referrals * Educational materials regarding diabetes, physical activity, and depression |
| Staged Care Management | Experimental | Adult patients with diabetes and depression Receives: Behavioral: Medication Care Management (MCM); Behavioral: Cognitive-Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant HbA1c levels
Measured: one year
Participant cardiovascular risk index
Measured: one year
Secondary outcomes (5)
Proximal intervention targets
(e.g., depressive symptoms, physical activity levels, and provider-patient communication)
Measured: one year
Other self-care behaviors
Measured: one year
Health-related quality of life
Measured: one year
Treatment satisfaction
Measured: one year
Resource use
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startMay 2005
- Primary completionOct 2009
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs, Genesys Health System, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, John Piette, University of Michigan
- Investigators
- John D Piette, PhD, Principal investigator, VA Ann Arbor Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106885
- Sponsor's protocol ID
- 1R18DK066166-01A1
- Other IDs
- 1R18DK066166-01A1
- Status last verified
- Apr 2015
- First submitted
- 15 Apr 2010
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Piette JD, Valenstein M, Himle J, Duffy S, Torres T, Vogel M, Richardson C. Clinical complexity and the effectiveness of an intervention for depressed diabetes patients. Chronic Illn. 2011 Dec;7(4):267-78. doi: 10.1177/1742395311409259. Epub 2011 Aug 12.
PubMed 21840915
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Care Management of Depressed Diabetes Patients
- ClinicalTrials.gov ID
- NCT01106885
- Acronym / sponsor ID
- 1R18DK066166-01A1
- Conditions
- Diabetes, Depression
- Keywords
- Diabetes, Depression, Telephone Care Management, Medication Care Management (MCM), Cognitive Behavioral Therapy (CBT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs, Genesys Health System, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 20 Apr 2010 (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.
Evaluation of telephone care management intervention designed to improve outcomes among depressed diabetes patients.
Detailed description
Research Plan: 382 patients ages 21-80, including 177 women, and 123 Blacks from the Ann Arbor VA HCS, UM, and the Genesys Health Care System in Flint. Patients will be randomized to: (1) brief education about depression, diabetes self-care, and physical activity; or (2) telephone care management including antidepressant medication care management (MCM) and/or cognitive behavioral therapy (CBT). The MCM module uses a standard algorithm to identify efficacious antidepressants and promote adherence. The CBT module addresses symptoms, exercise, and communication skills.
Methods: Surveys: Patients will complete clinic-based surveys at baseline and 12-months to measure their health status, self-care, provider-patient communication, and resource use. At 4 months, they will complete a mailed questionnaire to capture short-term changes in depressive symptoms, walking, patient-provider communication, medication adherence, and quality-of-life. Physiologic Measures: At baseline and 12-months, patients' A1c and cholesterol will be measured via a fingerstick blood test. We also will measure blood pressure, height, and weight. With patients' 4-month mailed surveys, they will complete fingerstick A1c tests and return the results via mail. The blood tests are identical to those diabetes patients use to self-monitor their blood glucose. Pedometers: We will measure distance walked at baseline, 4 months, and 12 months using a pedometer. Patients will record their walk distances for one week and return the results via mail. Electronic data: Utilization and billing databases will be used to identify health service utilization (ER visits, outpatient care, hospitalizations) occurring during patients' participation and the prior 12 months. Physician feedback. At patients' 12-month assessment, the physician will complete a brief survey about the patient's communication style. All patients will provide written consent administered prior to their face-to-face screening and baseline interviews. Physician 12-month surveys about patients' communication style will be anonymous.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care | No intervention | –Adult patients with diabetes and depression. * Report screening results * Notify PCP of screening results (optional per patient) * PCP referrals * Educational materials regarding diabetes, physical activity, and depression |
| Staged Care Management | Experimental | Behavioral: Medication Care Management (MCM), Behavioral: Cognitive-Behavioral Therapy (CBT)Adult patients with diabetes and depression |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Medication Care Management (MCM)* Basic physical activity counseling * Notify PCP and facilitate initiation of antidepressants * Medication monitoring calls at 1, 2, 4, 6, 8, 10, and 12 weeks* * 1/mo monitoring in continuation phase (mos. 4-12)* * Report \& recommendations to PCP after each patient call * Note: *average of 10 minutes of telephone time each (series is repeated if second antidepressant trial is needed) | Behavioural | Staged Care Management |
| Cognitive-Behavioral Therapy (CBT)* Notify PCP * CBT Manual * Weekly CBT focused counseling for 12 weeks** * Monthly CBT in months 4-12** * Behavioral physical activity counseling * Report \& recommendations to PCP after each patient call * Note: **average of 50 minutes of telephone time each | Behavioural | Staged Care Management |
Primary outcome
Participant HbA1c levels
Time frame: one year
Participant cardiovascular risk index
Time frame: one year
5 secondary outcomes
Proximal intervention targets
Time frame: one year
Other self-care behaviors
Time frame: one year
Health-related quality of life
Time frame: one year
Treatment satisfaction
Time frame: one year
Resource use
Time frame: one year
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 2015.
- Derived from this study: PubMed 21840915Piette JD, Valenstein M, Himle J, Duffy S, Torres T, Vogel M, Richardson C. Clinical complexity and the effectiveness of an intervention for depressed diabetes patients. Chronic Illn. 2011 Dec;7(4):267-78. doi: 10.1177/1742395311409259. Epub 2011 Aug 12.
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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.
John D Piette, PhD principal investigator
VA Ann Arbor Healthcare System
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Care Management (MCM) and Cognitive-Behavioral Therapy (CBT) in people with Diabetes and Depression, run by University of Michigan at 3 sites 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?
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 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Participant HbA1c levels (time frame: one year). The study lists 2 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 NCT01106885, which also lists 1 linked publication.
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 2015.