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Clinical Trials/NCT02224963
NCT02224963
Completed
N/A

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

University of Rochester1 site in 1 country216 target enrollmentMay 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Age-related Macular Degeneration
Sponsor
University of Rochester
Enrollment
216
Locations
1
Primary Endpoint
Psychological Well-being
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 2009
End Date
April 1, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Silvia Sorensen

Research Associate Professor

University of Rochester

Eligibility Criteria

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

Outcomes

Primary Outcomes

Psychological Well-being

Time Frame: 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."

Secondary Outcomes

  • Change in Preparation for Future Care(from baseline to 16 weeks (immediately post-intervention))
  • Preparation for Future Care(at 6-month follow-up)

Study Sites (1)

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