Macular Degeneration and Aging Study

Age-related Macular Degeneration Clinical Trial

— MADAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02224963
• Other study ID #: AG 032032
• Status: Completed
• Phase: N/A
• Start date: May 2009
• Est. completion date: April 1, 2019

Study information

• Verified date: April 2019
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: April 1, 2019
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester	Association for the Blind and Visually Impaired, Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological Well-being	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)
Primary	Psychological Well-being	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
Secondary	Change in Preparation for Future Care	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)
Secondary	Preparation for Future Care	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