Confronting Unequal Eye Care in Pennsylvania
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19107
- Thomas Jefferson University
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Philadelphia, Pennsylvania, 미국, 19140
- Temple University
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Philadelphia, Pennsylvania, 미국, 19107
- Wills Eye Health System
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Pt. 1
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Inclusion Criteria:
- Glaucoma (physician diagnosis)
- 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
Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Pt. 1 Behavioral Activation
Behavioral 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).
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Baseline assessment plus 4 in-home problem solving therapy sessions.
다른 이름들:
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위약 비교기: Pt. 1 Supportive Therapy
The 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.
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Baseline assessment plus 4 in-home sessions of supportive therapy.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pt. 1 Dilated Fundus Exam (DFE)
기간: 6-month follow-up assessment
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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
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6-month follow-up assessment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pt. 1 Risk perceptions of diabetes
기간: 6-month follow up assessment
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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 |
6-month follow up assessment
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Pt. 1 Diabetes self-care behaviors
기간: 6-month follow up assessment
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Yields a global scale that summarizes self-care behaviors
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6-month follow up assessment
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Pt. 1 Depressive Symptoms
기간: 6-month follow up assessment
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Patient Health Questionnaire-9 (PHQ-9)
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6-month follow up assessment
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Pt. 2 Appointment Adherence Characteristics
기간: Dependent on Diagnosis
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To assess the relationship between appointment adherence and particular demographic characteristics, clinical factors, and systems-level variables.
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Dependent on Diagnosis
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pt. 2 Cost-effectiveness
기간: Conclusion of Study
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To determine which aspects of the intervention are most costly, and whether these aspects can be delivered more efficiently in order to promote broader translation.
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Conclusion of Study
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Julia Haller, MD, Wills Eye
- 연구 책임자: Lisa Hark, PhD, RD, Wills Eye
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CURE-1837
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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