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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19107
- Thomas Jefferson University
-
Philadelphia, Pennsylvania, Estados Unidos, 19140
- Temple University
-
Philadelphia, Pennsylvania, Estados Unidos, 19107
- Wills Eye Health System
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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).
|
Baseline assessment plus 4 in-home problem solving therapy sessions.
Outros nomes:
|
|
Comparador de Placebo: 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.
|
Baseline assessment plus 4 in-home sessions of supportive therapy.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pt. 1 Dilated Fundus Exam (DFE)
Prazo: 6-month follow-up assessment
|
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
|
6-month follow-up assessment
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pt. 1 Risk perceptions of diabetes
Prazo: 6-month follow up assessment
|
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
|
|
Pt. 1 Diabetes self-care behaviors
Prazo: 6-month follow up assessment
|
Yields a global scale that summarizes self-care behaviors
|
6-month follow up assessment
|
|
Pt. 1 Depressive Symptoms
Prazo: 6-month follow up assessment
|
Patient Health Questionnaire-9 (PHQ-9)
|
6-month follow up assessment
|
|
Pt. 2 Appointment Adherence Characteristics
Prazo: Dependent on Diagnosis
|
To assess the relationship between appointment adherence and particular demographic characteristics, clinical factors, and systems-level variables.
|
Dependent on Diagnosis
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pt. 2 Cost-effectiveness
Prazo: Conclusion of Study
|
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.
|
Conclusion of Study
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Julia Haller, MD, Wills Eye
- Diretor de estudo: Lisa Hark, PhD, RD, Wills Eye
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CURE-1837
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Behavioral Activation
-
ElMindA LtdDesconhecidoSaudável | Comprometimento Cognitivo | Desordem neurológicaEstados Unidos
-
Korea Health Industry Development InstituteRecrutamentoDoença de ParkinsonRepublica da Coréia
-
Florida International UniversityAinda não está recrutandoTranstorno de Déficit de Atenção e HiperatividadeEstados Unidos
-
Square2 Systems, Inc.National Institute on Drug Abuse (NIDA)RecrutamentoTranstornos Relacionados a Substâncias | Transtornos por Uso de SubstânciasEstados Unidos
-
Oregon Research InstituteNational Institute on Drug Abuse (NIDA)ConcluídoProblemas de comportamento disruptivo na infânciaEstados Unidos
-
CVRx, Inc.ConcluídoInsuficiência cardíacaEstados Unidos
-
CVRx, Inc.ConcluídoHipertensãoHolanda, Suíça, Alemanha