Workshops for Veterans With Vision and Hearing Loss

Early Phase 1

Completed

• Conditions: Deafness; Blindness
• Interventions: Behavioral: DSL Workshop

• Registration Number: NCT01109576
• Lead Sponsor: US Department of Veterans Affairs

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.

Study Timeline

• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-23
• Study Start: 2011-11
• Primary Completion: 2012-07
• Study Completion: 2013-08
• Results First Submitted: 2015-06-04
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-28
• Last Update Submitted: 2015-08-28
• Results First Posted: 2015-09-29
• Last Update Posted: 2015-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DSL workshop participants	DSL Workshop	Three to five Veterans with DSL.

Primary Outcome Measures

Name	Time	Method
Change in Profile of Mood States Total Score.	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.

Trial Locations

Locations (2)

VA Portland Health Care System, Portland, OR; 🇺🇸 Portland, Oregon, United States

Atlanta VA Medical and Rehab Center, Decatur; 🇺🇸 Decatur, Georgia, United States