Clinical trial NCT02224963: Macular Degeneration and Aging Study
Official title: Improving Care Planning and Well-being in Older Adults With Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Macular Degeneration
Keywords: Aging,
Macular Degeneration,
Preparation for Future Care,
Psychological Well-being,
Problem Solving
Prevention
Mental Health Promotion
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Dartmouth-Hitchcock Medical Center
name: Association for the Blind and Visually Impaired
First posted: 2014-08-25
Enrollment: 216
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Psychological Well-being
timeFrame: at 16 weeks (immediately post-intervention)
measure: Psychological Well-being
timeFrame: at 6-month follow-up
Secondary outcomes:
measure: Change in Preparation for Future Care
timeFrame: from baseline to 16 weeks (immediately post-intervention)
measure: Preparation for Future Care
timeFrame: at 6-month follow-up
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Silvia Sörensen, PhD
role: PRINCIPAL_INVESTIGATOR
References: