DepressionNCT02178176
Participatory Design of Patient-centered Depression and Diabetes Care
A study testing Education, encouragement, card sort and Education, encouragement in people with Depression and Type 2 Diabetes Mellitus, run by University of Pennsylvania at 1 site in United States.
Trial summary
The burden of diabetes is anticipated to grow yet the proportion of adults whose diabetes is controlled is decreasing over time. This project can have a significant public health impact because we are refining and pilot testing a primary-care based intervention aimed at improving patient engagement and function which… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Type 2 Diabetes Mellitus
- What is being tested?
- Education, encouragement, card sort and Education, encouragement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Feb 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- a current diagnosis of Type 2 DM
- HbA1c 7%
- current prescription for an oral hypoglycemic agent
- able to communicate in English
- willing to give informed consent
Who cannot join
- acutely suicidal or psychotic (patients will not be randomized and PI or physician covering for PI will be paged immediately)
- significant cognitive impairment at baseline (a total score on Mini-Mental State Examination (MMSE) 21)
- markedly shortened life expectancy (diagnosis of metastatic cancer, end-stage renal disease on dialysis, or NYHA Class III or IV congestive heart failure)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The burden of diabetes is anticipated to grow yet the proportion of adults whose diabetes is controlled is decreasing over time. This project can have a significant public health impact because we are refining and pilot testing a primary-care based intervention aimed at improving patient engagement and function which are critical components of diabetes care and are associated with improved glycemic control, lower disease-related health-care expenditures, and reduced mortality.
- Conditions
- Depression, Type 2 Diabetes Mellitus
- Being tested
- Education, encouragement, card sort, Education, encouragement
- Medical subject headings
- Depression, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education, encouragement, card sortBehavioural
Patients will identify factors involved in nonadherence. For each factor influencing adherence, the interventionist will engage the patient in a 4-step problem solving process.
We will recognize patients' social and cultural context by addressing health-related priorities identified by the patient. The goal will be to identify those priorities which are likely to influence engagement in care and adherence to treatment. We will assess both biomedical (physical symptoms, diet and exercise) and nonbiomedical (financial, social and emotional) needs patients with Type 2 diabetes mellitus and depressive symptoms may wish to discuss in the context of their health. After the patients complete the card sort, interventionists will engage the patient in the 4-step problem solving process.
Education, encouragementBehavioural
Patients will identify factors involved in nonadherence. For each factor influencing adherence, the interventionist will engage the patient in a 4-step problem solving process.
| Study group | Role | What they receive |
|---|---|---|
| Education, encouragement, card sort | Experimental | Not described Receives: Behavioral: Education, encouragement, card sort |
| Education, encouragement | Active comparator | Not described Receives: Behavioral: Education, encouragement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression: nine-item Patient Health Questionnaire (PHQ-9)
Measured: Baseline and 14 weeks
Glycemic control: hemoglobin A1c
Measured: Baseline and 14 weeks
Adherence to oral hypoglycemic agents: Medication Event Monitoring System
Measured: Over 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startSep 2013
- Primary completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hillary Bogner, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178176
- Sponsor's protocol ID
- 1K18HS023445-01
- Status last verified
- May 2016
- First submitted
- 26 Jun 2014
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participatory Design of Patient-centered Depression and Diabetes Care
- ClinicalTrials.gov ID
- NCT02178176
- Acronym / sponsor ID
- 1K18HS023445-01
- Conditions
- Depression, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2015 (actual)
- First posted
- 30 Jun 2014 (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.
The burden of diabetes is anticipated to grow yet the proportion of adults whose diabetes is controlled is decreasing over time. This project can have a significant public health impact because we are refining and pilot testing a primary-care based intervention aimed at improving patient engagement and function which are critical components of diabetes care and are associated with improved glycemic control, lower disease-related health-care expenditures, and reduced mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education, encouragement, card sort | Experimental | Behavioral: Education, encouragement, card sort |
| Education, encouragement | Active comparator | Behavioral: Education, encouragement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years and older
- a current diagnosis of Type 2 DM
- HbA1c 7%
- current prescription for an oral hypoglycemic agent
- able to communicate in English
Key exclusion criteria (3 listed)
- acutely suicidal or psychotic (patients will not be randomized and PI or physician covering for PI will be paged immediately)
- significant cognitive impairment at baseline (a total score on Mini-Mental State Examination (MMSE) 21)
- markedly shortened life expectancy (diagnosis of metastatic cancer, end-stage renal disease on dialysis, or NYHA Class III or IV congestive heart failure)
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 |
|---|---|---|
| Education, encouragement, card sortPatients will identify factors involved in nonadherence. For each factor influencing adherence, the interventionist will engage the patient in a 4-step problem solving process. We will recognize patients' social and cultural context by addressing health-related priorities identified by the patient. The goal will be to identify those priorities which are likely to influence engagement in care and adherence to treatment. We will assess both biomedical (physical symptoms, diet and exercise) and nonbiomedical (financial, social and emotional) needs patients with Type 2 diabetes mellitus and depressive symptoms may wish to discuss in the context of their health. After the patients complete the card sort, interventionists will engage the patient in the 4-step problem solving process. | Behavioural | Education, encouragement, card sort |
| Education, encouragementPatients will identify factors involved in nonadherence. For each factor influencing adherence, the interventionist will engage the patient in a 4-step problem solving process. | Behavioural | Education, encouragement |
Primary outcome
Depression: nine-item Patient Health Questionnaire (PHQ-9)
Time frame: Baseline and 14 weeks
Glycemic control: hemoglobin A1c
Time frame: Baseline and 14 weeks
Adherence to oral hypoglycemic agents: Medication Event Monitoring System
Time frame: Over 14 weeks
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 17 May 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education, encouragement, card sort and Education, encouragement in people with Depression and Type 2 Diabetes Mellitus, run by University of Pennsylvania 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 6 inclusion and 3 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 17 May 2016. 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?
Depression: nine-item Patient Health Questionnaire (PHQ-9) (time frame: Baseline and 14 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2016; AzTrials last refreshed its copy on 7 Nov 2026.