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Macular Degeneration and Aging Study (MADAS)

Primary Purpose

Age-related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preventive Problem-Solving Training
Life and Health Review
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Age-related Macular Degeneration focused on measuring Aging,, Macular Degeneration,, Preparation for Future Care,, Psychological Well-being,, Problem Solving, Prevention, Mental Health Promotion

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Preventive Problem-Solving Training

Life and Health Review

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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."
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."

Secondary Outcome Measures

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
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

Full Information

First Posted
July 3, 2014
Last Updated
April 11, 2019
Sponsor
University of Rochester
Collaborators
Dartmouth-Hitchcock Medical Center, Association for the Blind and Visually Impaired
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1. Study Identification

Unique Protocol Identification Number
NCT02224963
Brief Title
Macular Degeneration and Aging Study
Acronym
MADAS
Official Title
Improving Care Planning and Well-being in Older Adults With Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 2009 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Dartmouth-Hitchcock Medical Center, Association for the Blind and Visually Impaired

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration
Keywords
Aging,, Macular Degeneration,, Preparation for Future Care,, Psychological Well-being,, Problem Solving, Prevention, Mental Health Promotion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preventive Problem-Solving Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Life and Health Review
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Preventive Problem-Solving Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Life and Health Review
Intervention Description
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 Outcome Measure Information:
Title
Psychological Well-being
Description
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."
Time Frame
at 16 weeks (immediately post-intervention)
Title
Psychological Well-being
Description
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."
Time Frame
at 6-month follow-up
Secondary Outcome Measure Information:
Title
Change in Preparation for Future Care
Description
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
Time Frame
from baseline to 16 weeks (immediately post-intervention)
Title
Preparation for Future Care
Description
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
Time Frame
at 6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Sörensen, PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Macular Degeneration and Aging Study

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