Workshops for Veterans With Vision and Hearing Loss (DSLW)
This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Atlanta VA Medical Center
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01109576
First received: April 19, 2010
Last updated: April 24, 2013
Last verified: April 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Deafness Blindness |
Behavioral: DSL Workshop |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Pilot Study: Self Management Groups for Veterans With Dual Sensory Loss |
Resource links provided by NLM:
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
- Profile of Mood States will measure psychosocial adaptation to dual sensory loss [ Time Frame: baseline to 8 weeks ] [ Designated as safety issue: No ]Sixty five item questionnaire assessing reports of recent mood states along a 5 item response scale. The POMS provides 7 scores, 1 Total Mood Disturbance score and 6 mood factor scores: Depression-dejection; Anger-hostility; Vigor-activity; Fatigue-inertia; Confusion-bewilderment; and Tension-anxiety. A score of 30 on any of the mood factor scores. A table of comparative populations, with the Total Mood Disturbance score means and standard deviations is provided.
| Estimated Enrollment: | 24 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | July 2013 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
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 Name: Dual Sensory Loss Self Management Groups
|
|
No Intervention: Arm 2
Wait-list Control group. Veterans do not participate in DSL groups until after 8 week outcomes of no intervention.
|
|
|
Experimental: Arm 3
Wait-list controls participate in DSL Workshop after their 8 week outcomes The 16 week outcome of this intervention is compared to 8 week outcome of this group and the experimental group.
|
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 Name: Dual Sensory Loss Self Management Groups
|
Detailed Description:
This pilot study will enroll 24 Veterans with Dual Sensory Loss (DSL). The project headquarters in the Portland Oregon VAMC will be tasked with the development of the workshops and writing of a Curriculum and Procedures Manual. The Atlanta VAMC research collaborators will enroll the 24 Veterans who will be randomly assigned to Immediate Care DSL Workshops or Wait-List Control. The six weekly two hour workshops will provide information, skills training and exercises about self-managing DSL. Preliminary effectiveness data will be collected and analyzed, and a large scale clinical trial will be proposed as a followup to explore the efficacy of this management approach.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Veteran;
- Vision loss > 20/70 better eye;
- Hearing loss > 40dB better ear;
- Cognition 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109576
Locations
| United States, Georgia | |
| Atlanta VA Medical and Rehab Center, Decatur | |
| Decatur, Georgia, United States, 30033 | |
| United States, Oregon | |
| VA Medical Center, Portland | |
| Portland, Oregon, United States, 97201 | |
Sponsors and Collaborators
Atlanta VA Medical Center
Investigators
| Principal Investigator: | Mitchel B Turbin | VA Medical Center, Portland |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01109576 History of Changes |
| Other Study ID Numbers: | C7460-P |
| Study First Received: | April 19, 2010 |
| Last Updated: | April 24, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by 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 Deaf-Blind Disorders Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms Vision Disorders Eye Diseases Abnormalities, Multiple Congenital Abnormalities |
ClinicalTrials.gov processed this record on May 21, 2013