DSLW: Workshops for Veterans With Vision and Hearing Loss

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01109576
• Collaborator: Atlanta VA Medical Center (U.S. Fed)
• Enrollment: 13
• Locations: 2
• Arm: 1
• Duration (Months): 21
• Patients Per Site: 6.5
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Deafness; Blindness	Behavioral: DSL Workshop	Early Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Pilot Study: Self Management Groups for Veterans With Dual Sensory Loss
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atlanta VA Medical and Rehab Center, Decatur	Decatur	Georgia	United States	30033
2	VA Portland Health Care System, Portland, OR	Portland	Oregon	United States	97201

Sponsors and Collaborators

• US Department of Veterans Affairs
• Atlanta VA Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT01109576
• Other Study ID Numbers: C7460-P
• First Posted: Apr 23, 2010
• Last Update Posted: Sep 29, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by US Department of Veterans Affairs: deafness-blindness; pilot study; self management education; dual sensory loss; rehabilitation; peer support groups; age related
• Additional relevant MeSH terms: Deafness; Hearing Loss; Blindness

Study Results

Participant Flow

Arm/Group Title	DSL Workshop Participants
Arm/Group Description	Three to five Veterans with DSL. 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. Participant Flow Completed: Twelve participants completed the entire protocol, including all outcomes measures.
Period Title: Overall Study
STARTED	13
COMPLETED	12
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	DSL Workshop Participants
Arm/Group Description	Three to five Veterans with DSL. 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.
Overall Participants	13
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 7.7%
>=65 years	12 92.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	85 (7.9)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	13 100%
Region of Enrollment (participants) [Number]
United States	13 100%
Profiles of Mood States Total Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	16 (26.2)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DSL Workshop Participants
Arm/Group Description	Three to five Veterans with DSL. 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.
Measure Participants	12
Mean (Standard Deviation) [units on a scale]	4.5 (21.9)

Adverse Events

Arm/Group Title	DSL Workshop Participants
Arm/Group Description	Dual Sensory Loss (DSL) workshop participants. Three to five Veterans with DSL. 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.
All Cause Mortality
	DSL Workshop Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	DSL Workshop Participants
	Affected / at Risk (%)	# Events
Total	1/13 (7.7%)
Psychiatric disorders
suicidal ideations	1/13 (7.7%)	1
Other (Not Including Serious) Adverse Events
	DSL Workshop Participants
	Affected / at Risk (%)	# Events
Total	0/13 (0%)

Limitations/Caveats

The sample size was too small to draw any definitive conclusion from the data.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.