Workshops for Veterans With Vision and Hearing Loss

Deafness Clinical Trial

— DSLW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109576
• Other study ID #: C7460-P
• Status: Completed
• Phase: Phase 0
• First received: April 19, 2010
• Last updated: August 28, 2015
• Start date: November 2011
• Est. completion date: August 2013

Study information

• Verified date: August 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Blindness
• Deafness

Intervention

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.

Locations

Country	Name	City	State
United States	Atlanta VA Medical and Rehab Center, Decatur	Decatur	Georgia
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Atlanta VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change in Profile of Mood States Score from Baseline to 8 Weeks	No