Workshops for Veterans With Vision and Hearing Loss (DSLW)

August 28, 2015 updated by: US Department of Veterans Affairs

Pilot Study: Self Management Groups for Veterans With Dual Sensory Loss

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Atlanta VA Medical and Rehab Center, Decatur
    • Oregon
      • Portland, Oregon, United States, 97201
        • VA Portland Health Care System, Portland, OR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DSL workshop participants
Three to five Veterans with DSL.
Behavioral: DSL Workshop
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.
Other Names:
  • Dual Sensory Loss Self Management Groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Profile of Mood States Total Score.
Time Frame: Change in Profile of Mood States Score from Baseline to 8 Weeks
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.
Change in Profile of Mood States Score from Baseline to 8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Collaborators

Atlanta VA Medical Center

Investigators

  • Principal Investigator: Mitchel Turbin, PhD, Veterans Health Administration (VHA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

April 19, 2010

First Submitted That Met QC Criteria

April 22, 2010

First Posted (ESTIMATE)

April 23, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 29, 2015

Last Update Submitted That Met QC Criteria

August 28, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C7460-P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Deafness

Clinical Trials on DSL Workshop

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe