<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02224963</url>
  </required_header>
  <id_info>
    <org_study_id>AG 032032</org_study_id>
    <nct_id>NCT02224963</nct_id>
  </id_info>
  <brief_title>Macular Degeneration and Aging Study</brief_title>
  <acronym>MADAS</acronym>
  <official_title>Improving Care Planning and Well-being in Older Adults With Macular Degeneration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Association for the Blind and Visually Impaired</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Rochester</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this randomized trial is to examine the effectiveness of a psycho-social&#xD;
      &quot;Preventive Problem Solving Intervention&quot; on emotional well-being, change in future outlook,&#xD;
      and vision functioning in 250 Age-related Macular Degeneration patients 60 and older.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Loss of independence and valued activities places Age-related Macular Degeneration (AMD)&#xD;
      patients at increased risk for depression, anxiety, and disability. Patients' emotional and&#xD;
      behavioral responses to AMD can exacerbate the long-term health threat of the disease and&#xD;
      contribute to preventable health care costs, loss of productivity, and burden to family&#xD;
      members.This is a randomized controlled trial of a psycho-social intervention that addresses&#xD;
      three mental health promotion goals: (1) increase emotional well-being, (2) improve future&#xD;
      outlook, and (3) protect or enhance current and future-oriented functioning.&#xD;
&#xD;
      The trial examines the effects of the PREPSI for 250 AMD patients, 60 and older, regardless&#xD;
      of actual vision acuity. All study participants receive 4 group-based vision education&#xD;
      classes and resource information. Subjects are then randomized to Preventive Problem Solving&#xD;
      Intervention (PREPSI) consisting of 8 sessions with certified problem-solving trainers or to&#xD;
      an Enhanced Attention Control arm.&#xD;
&#xD;
      Assessors blind to treatment condition measure Psychological Well-being immediately&#xD;
      post-intervention (Week 16) and at 6-month follow-up, Change in Future Outlook, including&#xD;
      Preparation for Future Care from baseline to 16 week and 6-month follow-up, and Vision&#xD;
      Functioning at 6 month follow-up. Measures include the Psychological Well-being Scale (Ryff &amp;&#xD;
      Keyes, 1995), the Preparation of Future Care Needs Scale (Sörensen &amp; Pinquart, 2001), and the&#xD;
      National Eye Institute Vision Functioning Questionnaire-25 (Stelmack, Stelmack, &amp; Massof,&#xD;
      2002). The primary hypothesis is that PREPSI participants will report greater Psychological&#xD;
      Well-being and more Preparation for Future Care immediately post-intervention (at 16 weeks)&#xD;
      and at 6-month follow-up.&#xD;
&#xD;
      The PREPSI is a short, standardized modification of problem-solving therapy that trains&#xD;
      participants to identify and clearly define current and future problems, and then generate,&#xD;
      evaluate, choose, and implement solutions. The long-term goal of the investigators research&#xD;
      program is to improve quality of life in late adulthood by conducting basic and translational&#xD;
      research on preventive future planning.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2009</start_date>
  <completion_date type="Actual">April 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Psychological Well-being</measure>
    <time_frame>at 16 weeks (immediately post-intervention)</time_frame>
    <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 &quot;1-disagree strongly&quot; and &quot;6-agree strongly.&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Psychological Well-being</measure>
    <time_frame>at 6-month follow-up</time_frame>
    <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 &quot;1-disagree strongly&quot; and &quot;6-agree strongly.&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Preparation for Future Care</measure>
    <time_frame>from baseline to 16 weeks (immediately post-intervention)</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preparation for Future Care</measure>
    <time_frame>at 6-month follow-up</time_frame>
    <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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">216</enrollment>
  <condition>Age-related Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>Preventive Problem-Solving Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Life and Health Review</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Preventive Problem-Solving Training</intervention_name>
    <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.</description>
    <arm_group_label>Preventive Problem-Solving Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Life and Health Review</intervention_name>
    <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.</description>
    <arm_group_label>Life and Health Review</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of AMD&#xD;
&#xD;
          -  60 years and older&#xD;
&#xD;
          -  Able to communicate in English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant cognitive impairment at baseline (total score on Mini Mental State Exam&#xD;
             (MMSE) for the Blind &lt;18, equivalent to &lt;21 in the regular MMSE);&#xD;
&#xD;
          -  Residence in a nursing home (assisted living facilities are acceptable);&#xD;
&#xD;
          -  Patient is acutely suicidal or psychotic&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Silvia Sörensen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>April 11, 2019</last_update_submitted>
  <last_update_submitted_qc>April 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Silvia Sorensen</investigator_full_name>
    <investigator_title>Research Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Aging,</keyword>
  <keyword>Macular Degeneration,</keyword>
  <keyword>Preparation for Future Care,</keyword>
  <keyword>Psychological Well-being,</keyword>
  <keyword>Problem Solving</keyword>
  <keyword>Prevention</keyword>
  <keyword>Mental Health Promotion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02224963
org study id: AG 032032
nct id: NCT02224963
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Psychological Well-being
time frame: at 16 weeks (immediately post-intervention)
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."
measure: Psychological Well-being
time frame: at 6-month follow-up
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."
measure: Change in Preparation for Future Care
time frame: from baseline to 16 weeks (immediately post-intervention)
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
measure: Preparation for Future Care
time frame: at 6-month follow-up
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
arm group label: Preventive Problem-Solving Training
arm group type: Experimental
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 group label: Life and Health Review
arm group type: Active Comparator
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: Preventive Problem-Solving Training
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 group label: Preventive Problem-Solving Training
intervention type: Behavioral
intervention name: Life and Health Review
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.
arm group label: Life and Health Review
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Silvia Sörensen, PhD
role: Principal Investigator
affiliation: University of Rochester
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Silvia Sorensen
investigator title: Research Associate Professor
mesh term: Macular Degeneration