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Confronting Unequal Eye Care in Pennsylvania

6. april 2017 oppdatert av: Julia Haller, Wills Eye

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

206

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, Forente stater, 19140
        • Temple University
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Wills Eye Health System

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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).
Atferdsmessig: Behavioral Activation
Baseline assessment plus 4 in-home problem solving therapy sessions.
Andre navn:
  • BA - abbreviation
Placebo komparator: 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.
Atferdsmessig: Supportive Therapy
Baseline assessment plus 4 in-home sessions of supportive therapy.
Andre navn:
  • ST-abbreviation

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pt. 1 Dilated Fundus Exam (DFE)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pt. 1 Risk perceptions of diabetes
Tidsramme: 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
Tidsramme: 6-month follow up assessment
Yields a global scale that summarizes self-care behaviors
6-month follow up assessment
Pt. 1 Depressive Symptoms
Tidsramme: 6-month follow up assessment
Patient Health Questionnaire-9 (PHQ-9)
6-month follow up assessment
Pt. 2 Appointment Adherence Characteristics
Tidsramme: Dependent on Diagnosis
To assess the relationship between appointment adherence and particular demographic characteristics, clinical factors, and systems-level variables.
Dependent on Diagnosis

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pt. 2 Cost-effectiveness
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Wills Eye

Samarbeidspartnere

Temple University
Thomas Jefferson University

Etterforskere

  • Hovedetterforsker: Julia Haller, MD, Wills Eye
  • Studieleder: Lisa Hark, PhD, RD, Wills Eye

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2010

Primær fullføring (Faktiske)

1. mai 2014

Studiet fullført (Faktiske)

1. mai 2014

Datoer for studieregistrering

Først innsendt

10. august 2010

Først innsendt som oppfylte QC-kriteriene

10. august 2010

Først lagt ut (Anslag)

11. august 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. april 2017

Sist bekreftet

1. april 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CURE-1837

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Several manuscripts have been published.

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