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Workshops for Veterans With Vision and Hearing Loss (DSLW)

Primary Purpose

Deafness, Blindness

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
DSL Workshop
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Deafness focused on measuring deafness-blindness, pilot study, self management education, dual sensory loss, rehabilitation, peer support groups, age related

Eligibility Criteria

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

Inclusion Criteria:

  • Veteran;
  • Vision loss > 20/70 better eye;
  • Hearing loss > 40 decibels better ear;
  • Cognition Within Normal Limits (WNL);
  • No behavioral flag or psychiatric diagnosis;
  • Documented psychosocial restrictions secondary to vision and hearing loss

Exclusion Criteria:

  • Vision and/or hearing can be corrected by surgical or pharmacological treatment;
  • Requires use of sign language interpreter

Sites / Locations

  • Atlanta VA Medical and Rehab Center, Decatur
  • VA Portland Health Care System, Portland, OR

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DSL workshop participants

Arm Description

Three to five Veterans with DSL.

Outcomes

Primary Outcome Measures

Change in Profile of Mood States Total Score.
The change in Profile of Mood States total score is defined as the 8 week follow-up total score minus the baseline POMS total score. The scale measures change in mood states before and after treatment. The change score can range from -232 to 232, with negative values indicating greater reduction in emotional distress.

Secondary Outcome Measures

Full Information

First Posted
April 19, 2010
Last Updated
August 28, 2015
Sponsor
US Department of Veterans Affairs
Collaborators
Atlanta VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01109576
Brief Title
Workshops for Veterans With Vision and Hearing Loss
Acronym
DSLW
Official Title
Pilot Study: Self Management Groups for Veterans With Dual Sensory Loss
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
Collaborators
Atlanta VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a pilot study of workshops to help Veterans with both vision and hearing loss live a happier, fuller and less stressful life. The results will be used to guide the development of a large scale clinical trial.
Detailed Description
This pilot study will enrolled 13 Veterans with Dual Sensory Loss (DSL), age 65 to over 89. The project headquarters in the Portland Oregon Veterans Affairs Medical Center will be tasked with the development of the workshops and writing of a Curriculum and Procedures Manual. The Atlanta VAMC research collaborators enrolled the 13 Veterans. Staff turnover reduced time available for enrollment and data collection. We therefore eliminated the original comparison group design and this study had only one experimental intervention arm and no control intervention or other arm. Veterans were chronologically enrolled who responded to recruitment letters and who passed telephone and onsite screening. The intervention consisted of six weekly two hour workshops providing information, skills training and exercises about self-managing DSL effects on daily life. Preliminary effectiveness data was collected and analyzed, and a large scale clinical trial will be proposed as a followup to explore the efficacy of this management approach. This study data tracked pre and post intervention within subject changes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness, Blindness
Keywords
deafness-blindness, pilot study, self management education, dual sensory loss, rehabilitation, peer support groups, age related

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DSL workshop participants
Arm Type
Experimental
Arm Description
Three to five Veterans with DSL.
Intervention Type
Behavioral
Intervention Name(s)
DSL Workshop
Other Intervention Name(s)
Dual Sensory Loss Self Management Groups
Intervention Description
A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers.
Primary Outcome Measure Information:
Title
Change in Profile of Mood States Total Score.
Description
The change in Profile of Mood States total score is defined as the 8 week follow-up total score minus the baseline POMS total score. The scale measures change in mood states before and after treatment. The change score can range from -232 to 232, with negative values indicating greater reduction in emotional distress.
Time Frame
Change in Profile of Mood States Score from Baseline to 8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veteran; Vision loss > 20/70 better eye; Hearing loss > 40 decibels better ear; Cognition Within Normal Limits (WNL); No behavioral flag or psychiatric diagnosis; Documented psychosocial restrictions secondary to vision and hearing loss Exclusion Criteria: Vision and/or hearing can be corrected by surgical or pharmacological treatment; Requires use of sign language interpreter
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchel Turbin, PhD
Organizational Affiliation
Veterans Health Administration (VHA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical and Rehab Center, Decatur
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States

12. IPD Sharing Statement

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Workshops for Veterans With Vision and Hearing Loss

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