Overview

This trial is active, not recruiting.

Condition age-related macular degeneration
Treatments preventive problem-solving training, life and health review
Sponsor University of Rochester
Collaborator Dartmouth-Hitchcock Medical Center
Start date May 2009
End date June 2016
Trial size 250 participants
Trial identifier NCT02224963, AG 032032

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking double blind (subject, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
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.
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.
(Active Comparator)
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.
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.

Primary Outcomes

Measure
Psychological Well-being
time frame: at 16 weeks (immediately post-intervention)
Psychological Well-being
time frame: at 6-month follow-up

Secondary Outcomes

Measure
Change in Preparation for Future Care
time frame: from baselin to 16 weeks (immediately post-intervention)
Preparation for Future Care
time frame: at 6-month follow-up

Eligibility Criteria

Male or female participants at least 60 years old.

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

Additional Information

Official title Improving Care Planning and Well-being in Older Adults With Macular Degeneration
Principal investigator Silvia Sörensen, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Rochester.