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Macular Degeneration and Aging Study (MADAS)

11. april 2019 oppdatert av: Silvia Sorensen, University of Rochester

Improving Care Planning and Well-being in Older Adults With Macular Degeneration

The purpose of this randomized trial is to examine the effectiveness of a psycho-social "Preventive Problem Solving Intervention" on emotional well-being, change in future outlook, and vision functioning in 250 Age-related Macular Degeneration patients 60 and older.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Loss of independence and valued activities places Age-related Macular Degeneration (AMD) patients at increased risk for depression, anxiety, and disability. Patients' emotional and behavioral responses to AMD can exacerbate the long-term health threat of the disease and contribute to preventable health care costs, loss of productivity, and burden to family members.This is a randomized controlled trial of a psycho-social intervention that addresses three mental health promotion goals: (1) increase emotional well-being, (2) improve future outlook, and (3) protect or enhance current and future-oriented functioning.

The trial examines the effects of the PREPSI for 250 AMD patients, 60 and older, regardless of actual vision acuity. All study participants receive 4 group-based vision education classes and resource information. Subjects are then randomized to Preventive Problem Solving Intervention (PREPSI) consisting of 8 sessions with certified problem-solving trainers or to an Enhanced Attention Control arm.

Assessors blind to treatment condition measure Psychological Well-being immediately post-intervention (Week 16) and at 6-month follow-up, Change in Future Outlook, including Preparation for Future Care from baseline to 16 week and 6-month follow-up, and Vision Functioning at 6 month follow-up. Measures include the Psychological Well-being Scale (Ryff & Keyes, 1995), the Preparation of Future Care Needs Scale (Sörensen & Pinquart, 2001), and the National Eye Institute Vision Functioning Questionnaire-25 (Stelmack, Stelmack, & Massof, 2002). The primary hypothesis is that PREPSI participants will report greater Psychological Well-being and more Preparation for Future Care immediately post-intervention (at 16 weeks) and at 6-month follow-up.

The PREPSI is a short, standardized modification of problem-solving therapy that trains participants to identify and clearly define current and future problems, and then generate, evaluate, choose, and implement solutions. The long-term goal of the investigators research program is to improve quality of life in late adulthood by conducting basic and translational research on preventive future planning.

Studietype

Intervensjonell

Registrering (Faktiske)

216

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
    • New York
      • Rochester, New York, Forente stater, 14642
        • University of Rochester

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

60 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosis of AMD
  • 60 years and older
  • Able to communicate in English.

Exclusion Criteria:

  • Significant cognitive impairment at baseline (total score on Mini Mental State Exam (MMSE) for the Blind <18, equivalent to <21 in the regular MMSE);
  • Residence in a nursing home (assisted living facilities are acceptable);
  • Patient is acutely suicidal or psychotic

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: Faktoriell oppgave
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Preventive Problem-Solving Training
Preventive Problem-solving Training is an adaptation of Problem-Solving Therapy that builds problem-solving skills and then focuses these skills on potential future problems. It aims to reduce avoidance of contemplation of future needs and enhance gathering information, decision-making, and concrete planning about future needs.
Atferdsmessig: Preventive Problem-Solving Training
Preventive Problem-solving Training is an adaptation of Problem-Solving Therapy that builds problem-solving skills and then focuses these skills on potential future problems. It aims to reduce avoidance of contemplation of future needs and enhance gathering information, decision-making, and concrete planning about future needs.
Aktiv komparator: Life and Health Review
Life and Health Review is an Enhanced Attention Control that provides classes and resource information modules, just as in intervention. It differs from the intervention in that we conduct an 8-session life and health review with subjects, in which they recount life experiences from childhood to the present.
Atferdsmessig: Life and Health Review
Life and Health Review is an Enhanced Attention Control that provides classes and resource information modules, just as in intervention. It differs from the intervention in that we conduct an 8-session life and health review with subjects, in which they recount life experiences from childhood to the present.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Psychological Well-being
Tidsramme: at 16 weeks (immediately post-intervention)
The 42-item multidimensional Psychological Well-Being scale (PWB) will assess 6 dimensions of PWB: Autonomy, Environmental Mastery, Personal Growth, Positive Relations With Others, Purpose In Life, and Self-Acceptance. The PWB is a Likert-scored self-report measure, with anchors of "1-disagree strongly" and "6-agree strongly."
at 16 weeks (immediately post-intervention)
Psychological Well-being
Tidsramme: at 6-month follow-up
The 42-item multidimensional Psychological Well-Being scale (PWB) will assess 6 dimensions of PWB: Autonomy, Environmental Mastery, Personal Growth, Positive Relations With Others, Purpose In Life, and Self-Acceptance. The PWB is a Likert-scored self-report measure, with anchors of "1-disagree strongly" and "6-agree strongly."
at 6-month follow-up

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Preparation for Future Care
Tidsramme: from baseline to 16 weeks (immediately post-intervention)
Preparation for Future Care Measure (PFCM) consists of 29 items in five subscales that assess specific behaviors representative of each of five processes observed in PFC: Awareness of care needs, Gathering Information, Deciding on Preferences, Making Concrete Plans, and Avoidance. It is rated on a fiv-point Likert Scale
from baseline to 16 weeks (immediately post-intervention)
Preparation for Future Care
Tidsramme: at 6-month follow-up
Preparation for Future Care Measure (PFCM) consists of 29 items in five subscales that assess specific behaviors representative of each of five processes observed in PFC: Awareness of care needs, Gathering Information, Deciding on Preferences, Making Concrete Plans, and Avoidance. It is rated on a fiv-point Likert Scale
at 6-month follow-up

Samarbeidspartnere og etterforskere

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

Sponsor

University of Rochester

Samarbeidspartnere

Dartmouth-Hitchcock Medical Center
Association for the Blind and Visually Impaired

Etterforskere

  • Hovedetterforsker: Silvia Sörensen, PhD, University of Rochester

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 (Faktiske)

1. mai 2009

Primær fullføring (Faktiske)

1. juni 2016

Studiet fullført (Faktiske)

1. april 2019

Datoer for studieregistrering

Først innsendt

3. juli 2014

Først innsendt som oppfylte QC-kriteriene

21. august 2014

Først lagt ut (Anslag)

25. august 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. april 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. april 2019

Sist bekreftet

1. april 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AG 032032

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