Early Phase 1
N=13
Workshops for Veterans With Vision and Hearing Loss
Deafness · Blindness
Bottom Line
View on ClinicalTrials.gov: NCT01109576 ↗Enrolled (actual)
13
Serious AEs
7.7%
Results posted
Sep 2015
Primary outcome: Primary: Change in Profile of Mood States Total Score. — 4.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- DSL Workshop (Behavioral)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Profile of Mood States Total Score. |
4.5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01109576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.