Workshops for Veterans With Vision and Hearing Loss (DSLW)

This study has been completed.
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: September 26, 2013
Last verified: September 2013
  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.


Enrollment: 13
Study Start Date: November 2011
Study Completion Date: August 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

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 VAMC 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 26, 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
Blindness
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vision Disorders
Eye Diseases

ClinicalTrials.gov processed this record on October 19, 2014