Macular Degeneration and Aging Study
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|
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.
|Intervention model||factorial assignment|
|Masking||double blind (subject, outcomes assessor)|
time frame: at 16 weeks (immediately post-intervention)
time frame: at 6-month follow-up
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
Male or female participants at least 60 years old.
- Diagnosis of AMD
- 60 years and older
- Able to communicate in English.
- 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
|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.|
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