Diabetic RetinopathyCC-DDRNCT02121340
Collaborative Care for Depression and Diabetic Retinopathy in African Americans
A study testing Behavioral Activation in people with Diabetic Retinopathy, run by Thomas Jefferson University at 2 sites in United States.
Trial summary
In this feasibility/pilot study, we will develop, refine, and evaluate the feasibility of a novel mental health/ophthalmologic intervention called, "Collaborative Care for Depression and Diabetic Retinopathy" (CC-DDR), which aims to treat depression and lower HbA1C in older African Americans with mild-to-moderate… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2014to Dec 2018
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- African-American race
- age ≥ 65 years
- type 2 diabetes
- mild or moderate nonproliferative DR with or without macular edema
- depressive symptoms (i.e., Patient Health Questionnaire-9 score ≥5)
- HbA1C ≥ 7.0%
Who cannot join
- treated proliferative DR
- global cognitive impairment (i.e., Mini Mental Status score ≤ 20)
- psychiatric diagnosis other than depression
- treatment for depression started in the previous 3 months
- life expectancy under 2 years
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
About this study
In this feasibility/pilot study, we will develop, refine, and evaluate the feasibility of a novel mental health/ophthalmologic intervention called, "Collaborative Care for Depression and Diabetic Retinopathy" (CC-DDR), which aims to treat depression and lower HbA1C in older African Americans with mild-to-moderate diabetic retinopathy (DR) and comorbid depression.
Read the detailed description
The Specific Aims are:
- To develop the CC-DDR treatment protocol. This will involve:
- Creating an initial version of the CC-DDR treatment protocol.
- Refining the protocol based on input from an expert panel with expertise in DR, depression, and culturally relevant interventions for diabetes in older African Americans.
- Developing a tool to assess interventionist treatment adherence and competence.
- To conduct an open trial of CC-DDR with 40 participants who have poorly controlled diabetes, depression, and mild or moderate DR. During this open trial we will:
- Evaluate the feasibility of CC-DDR.
- Refine the CC-DDR treatment protocol by incorporating feedback from participants, community health care workers (CHWs), ophthalmologists, and the expert panel.
- Refine procedures for recruitment and retention, outcome assessment, monitoring treatment fidelity, CHW training and supervision, quality assurance, and study administration, based on input from investigators, CHWs, participants, and the expert panel.
- Examine CC-DDR's impact on depression severity; diabetes self-management practices; HbA1C level; blood pressure; adherence to the ophthalmologist treatment plan; vision function; quality of life; and satisfaction with CC-DDR.
- To complete a Manual of Procedures that characterizes all aspects of the planned efficacy trial of CC-DDR.
- Conditions
- Diabetic Retinopathy
- Being tested
- Behavioral Activation
- Keywords
- Depression, Health disparities, African American, Geriatric
- Medical subject headings
- Diabetic Retinopathy, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation | Experimental | CC-DDR is a novel mental health/ophthalmologic intervention that we are designing to treat depression and lower HbA1C levels in older AAs with mild-to-moderate DR and comorbid depression. Community Health Workers, who match participants in race and cultural background, will work with ophthalmologists in the retina clinic to educate participants on the links between depression, HbA1C, and DR, and will extend care into the home where they will use Behavioral Activation to treat depression and improve diabetes self-management skills. Receives: Behavioral: Behavioral Activation |
| Usual Care | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Change in hemoglobin A1c from baseline to 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Wills Eye
- Responsible party
- Sponsor
- Investigators
- Barry Rovner, MD, Principal investigator, Thomas Jefferson UniversityRobin Casten, PhD, Study director, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121340
- Sponsor's protocol ID
- R34EY024299
- Acronym
- CC-DDR
- Status last verified
- Feb 2019
- First submitted
- 21 Apr 2014
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Care for Depression and Diabetic Retinopathy in African Americans
- ClinicalTrials.gov ID
- NCT02121340
- Acronym / sponsor ID
- CC-DDR / R34EY024299
- Conditions
- Diabetic Retinopathy
- Keywords
- Depression, Health disparities, African American, Geriatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Wills Eye
- Study start
- May 2014 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 23 Apr 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.
In this feasibility/pilot study, we will develop, refine, and evaluate the feasibility of a novel mental health/ophthalmologic intervention called, "Collaborative Care for Depression and Diabetic Retinopathy" (CC-DDR), which aims to treat depression and lower HbA1C in older African Americans with mild-to-moderate diabetic retinopathy (DR) and comorbid depression.
Detailed description
The Specific Aims are:
- To develop the CC-DDR treatment protocol. This will involve:
- Creating an initial version of the CC-DDR treatment protocol.
- Refining the protocol based on input from an expert panel with expertise in DR, depression, and culturally relevant interventions for diabetes in older African Americans.
- Developing a tool to assess interventionist treatment adherence and competence.
- To conduct an open trial of CC-DDR with 40 participants who have poorly controlled diabetes, depression, and mild or moderate DR. During this open trial we will:
- Evaluate the feasibility of CC-DDR.
- Refine the CC-DDR treatment protocol by incorporating feedback from participants, community health care workers (CHWs), ophthalmologists, and the expert panel.
- Refine procedures for recruitment and retention, outcome assessment, monitoring treatment fidelity, CHW training and supervision, quality assurance, and study administration, based on input from investigators, CHWs, participants, and the expert panel.
- Examine CC-DDR's impact on depression severity; diabetes self-management practices; HbA1C level; blood pressure; adherence to the ophthalmologist treatment plan; vision function; quality of life; and satisfaction with CC-DDR.
- To complete a Manual of Procedures that characterizes all aspects of the planned efficacy trial of CC-DDR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation | Experimental | Behavioral: Behavioral ActivationCC-DDR is a novel mental health/ophthalmologic intervention that we are designing to treat depression and lower HbA1C levels in older AAs with mild-to-moderate DR and comorbid depression. Community Health Workers, who match participants in race and cultural background, will work with ophthalmologists in the retina clinic to educate participants on the links between depression, HbA1C, and DR, and will extend care into the home where they will use Behavioral Activation to treat depression and improve diabetes self-management skills. |
| Usual Care | No intervention | –Usual Care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- African-American race
- age ≥ 65 years
- type 2 diabetes
- mild or moderate nonproliferative DR with or without macular edema
- depressive symptoms (i.e., Patient Health Questionnaire-9 score ≥5)
Key exclusion criteria (5 listed)
- treated proliferative DR
- global cognitive impairment (i.e., Mini Mental Status score ≤ 20)
- psychiatric diagnosis other than depression
- treatment for depression started in the previous 3 months
- life expectancy under 2 years
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 |
|---|---|---|
| Behavioral Activation | Behavioural | Behavioral Activation |
Primary outcome
Hemoglobin A1c
Time frame: 12 months
Change in hemoglobin A1c from baseline to 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 21 Feb 2019.
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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.
Barry Rovner, MD principal investigator
Thomas Jefferson University
Robin Casten, PhD study director
Thomas Jefferson University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation in people with Diabetic Retinopathy, run by Thomas Jefferson University at 2 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?
The sponsor lists 6 inclusion and 5 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 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Hemoglobin A1c (time frame: 12 months). 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 21 Feb 2019.