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Diabetic RetinopathyNCT01179555

Confronting Unequal Eye Care in Pennsylvania

A study testing Behavioral Activation and Supportive Therapy in people with Diabetic Retinopathy and Diabetes Mellitus, Type 2, run by Wills Eye at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pt. 1 Diabetic retinopathy is a common eye condition among diabetic adults and can lead to severe vision impairment and even blindness. African Americans are more likely to have vision loss from diabetic retinopathy due to a variety of factors, including cultural barriers to care. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Behavioral Activation and Supportive Therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
206 participants
Where
3 sitesUnited States
Study dates
Oct 2010to May 2014
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • African-American race (self-identified)
  • Age ≥ 65 years
  • Type II Diabetes Mellitus (physician diagnosis) for at least 1 year
  • No medical documentation of a DFE by an ophthalmologist or an optometrist within the past 12 months
  • Self-report of no DFE within the past 12 months
  • Glaucoma (physician diagnosis)
Show all 10Show fewer
  • Scheduled for a follow-up appointment that meets the American Academy of Ophthalmology (AAO) follow-up guidelines
  • Attended the Wills Eye Glaucoma Clinic from September 1, 2012 to October 31, 2013
  • Age ≥ 21 years old
  • Able to understand and speak English

Who cannot join

  • Cognitive Impairment (Mini-Mental Status Examination ≤ 24)
  • Current clinically significant psychiatric disorder other than depression
  • Current medical disorder that limits life expectancy (≤ 12 months) or need for dialysis
  • Hearing impairment that precludes research participation
  • Pt. 2
  • Diagnosed with a pre-existing medical condition that would preclude the subject from providing reliable and valid data
  • Individual was asked to follow-up in less than a month.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Wills Eye Health System

    Philadelphia, Pennsylvania, 19107

  • Temple University

    Philadelphia, Pennsylvania, 19140

Other trials in United States

About this study

Pt. 1 Diabetic retinopathy is a common eye condition among diabetic adults and can lead to severe vision impairment and even blindness. African Americans are more likely to have vision loss from diabetic retinopathy due to a variety of factors, including cultural barriers to care. The investigators aim to increase the rates of eye exams in diabetic African American adults by providing culturally relevant home-based interventions. These interventions will increase the knowledge about diabetes and the eyes and the awareness of ocular risks due to diabetes.

206 African American adults, over the age of 65, with diabetes will be recruited from primary care clinics at Thomas Jefferson and Temple University. Eligible patients who consent to participate will have baseline information taken about medical and ocular history, understanding of diabetes and a hemoglobin A1C level obtained. The subjects will then be randomized to one of two treatment conditions: Behavioral Activation or Supportive Therapy, each of which will be delivered over 4 sessions. Behavioral Activation will consist of educational materials, referral assistance for eye clinics, and addressing patient specific barriers to care. Supportive Therapy will consist of supportive but non-directional interaction with the patient exploring the impact of aging and diabetes on the patient's life. The investigators hypothesize that more patients who receive Behavioral Activation will have a dilated fundus exam (the primary outcome variable), understand the risks of diabetic complications and feel less depression then subjects who receive Supportive Therapy.

Read the detailed description

An additional aim was added to this project, examining the effect of a telephone intervention on eye care adherence and comparing the efficacy of the intervention to usual care and automated telephone screenings.

Glaucoma is a group of chronic, neurodegenerative diseases of the optic nerve, which leads to an increase in intraocular pressure, gradual changes in the visual field (VF), and progressive vision loss. Glaucomatous vision loss is preventable with proper eye care, including adherence to follow-up appointments and medications. Interventions that improve appointment adherence have the potential to prevent more severe glaucomatous disease. The primary purpose of this study is to determine the efficacy of a multifaceted intervention system, which includes a customized letter and personal telephone outreach, in improving appointment adherence in patients with glaucoma. In order to improve strategies to reduce the rate of appointment non-adherence, shared characteristics of adherent versus non-adherent patients with glaucoma will be identified and compared to patient characteristics in the previous literature. A secondary goal of this study is to analyze the cost-effectiveness of this multifaceted intervention on appointment adherence in patients with glaucoma.

Being tested
Behavioral Activation, Supportive Therapy
Keywords
Diabetic Complications, Intervention Studies, African Americans, Vision Screening, Vision, Low, Geriatric Assessment, Outcomes Assessment, Cultural Characteristics, Cultural Competency, Appointment Adherence, Cost-effectiveness, Personalization of care, Follow-up Care
Medical subject headings
Diabetic Retinopathy, Diabetes Mellitus, Type 2, Glaucoma, Diabetes Complications, Vision, Low

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral ActivationBehavioural

    Also called BA - abbreviation

    Baseline assessment plus 4 in-home problem solving therapy sessions.

  • Supportive TherapyBehavioural

    Also called ST-abbreviation

    Baseline assessment plus 4 in-home sessions of supportive therapy.

Study groups in NCT01179555
Study groupRoleWhat they receive
Pt. 1 Behavioral ActivationExperimentalBehavioral Activation (BA) is a behavioral technique to help people overcome avoidant tendencies through goal setting, activity scheduling, and graded task assignment. The key component of BA involves developing an "Action Plan", and having the subject document each step of the plan as he or she implements it, reinforcing the steps towards goal attainment. "Action Plans" are easily applied to diabetes self-care tasks because the latter lend themselves to documentation of simple, step-by-step plans. In this study, a Community Health Educator (CHE) - interventionist will schedule and deliver four 45-60 minute in-home BA sessions within 3 months of randomization (i.e., one session every 2-3 weeks).
Receives: Behavioral: Behavioral Activation
Pt. 1 Supportive TherapyPlacebo comparatorThe purpose of Supportive Therapy (ST) is to explore the impact of aging and diabetes on the subject's life. In contrast to the BA intervention, the interventionist does not discuss the importance of dilated eye exams. In subsequent sessions, ST facilitates and deepens knowledge about the subject's life situation in relation to his or her health and other life difficulties. The ST therapist encourages this process and creates an accepting, nondirective, and supportive opportunity for discussion.
Receives: Behavioral: Supportive Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pt. 1 Dilated Fundus Exam (DFE)

    At the 6-month follow-up assessment, patients will be asked if they got a dilated fundus exam since the baseline assessment. If a DFE is self-reported, it will be confirmed by ophthalmology chart review

    Measured: 6-month follow-up assessment

Secondary outcomes (4)

  1. Pt. 1 Risk perceptions of diabetes

    Risk Perception Survey-Diabetes Mellitus (RPS-DM) has 5 subscales:

    1. Personal Control, 2) Optimistic Bias, 3) Personal Disease Risk, 4) Comparative Environmental Risk, 5) Risk Knowledge

    Measured: 6-month follow up assessment

  2. Pt. 1 Diabetes self-care behaviors

    Yields a global scale that summarizes self-care behaviors

    Measured: 6-month follow up assessment

  3. Pt. 1 Depressive Symptoms

    Patient Health Questionnaire-9 (PHQ-9)

    Measured: 6-month follow up assessment

  4. Pt. 2 Appointment Adherence Characteristics

    To assess the relationship between appointment adherence and particular demographic characteristics, clinical factors, and systems-level variables.

    Measured: Dependent on Diagnosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01179555
Sponsor's protocol ID
CURE-1837
Status last verified
Apr 2017
First submitted
10 Aug 2010
Last updated
10 Apr 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Several manuscripts have been published.

Publications

  • Weiss DM, Casten RJ, Leiby BE, Hark LA, Murchison AP, Johnson D, Stratford S, Henderer J, Rovner BW, Haller JA. Effect of Behavioral Intervention on Dilated Fundus Examination Rates in Older African American Individuals With Diabetes Mellitus: A Randomized Clinical Trial. JAMA Ophthalmol. 2015 Sep;133(9):1005-12. doi: 10.1001/jamaophthalmol.2015.1760.

    PubMed 26068230

  • Rovner BW, Haller JA, Casten RJ, Murchison AP, Hark LA. Cultural and Cognitive Determinants of Personal Control in Older African Americans with Diabetes. J Natl Med Assoc. 2015 Jun;107(2):25-31. doi: 10.1016/S0027-9684(15)30021-3. Epub 2015 Dec 2.

    PubMed 27269487

  • Pizzi LT, Tran J, Shafa A, Waisbourd M, Hark L, Murchison AP, Dai Y, Mayro EL, Haller JA. Effectiveness and Cost of a Personalized Reminder Intervention to Improve Adherence to Glaucoma Care. Appl Health Econ Health Policy. 2016 Apr;14(2):229-40. doi: 10.1007/s40258-016-0231-8.

    PubMed 26924099

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Activation and Supportive Therapy in people with Diabetic Retinopathy and Diabetes Mellitus, Type 2, run by Wills Eye 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?

The sponsor lists 10 inclusion and 7 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 10 Apr 2017. 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. 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?

Pt. 1 Dilated Fundus Exam (DFE) (time frame: 6-month follow-up assessment). 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 NCT01179555, which also lists 3 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 10 Apr 2017.

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