Trial Outcomes & Findings for Workshops for Veterans With Vision and Hearing Loss (NCT NCT01109576)

Last Updated: 2015-09-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

13 participants

Primary outcome timeframe

Change in Profile of Mood States Score from Baseline to 8 Weeks

Results posted on

2015-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	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. Participant Flow Completed: Twelve participants completed the entire protocol, including all outcomes measures.
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Workshops for Veterans With Vision and Hearing Loss

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DSL Workshop Participants n=13 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	85 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants
Profiles of Mood States Total Score	16 units on a scale STANDARD_DEVIATION 26.2 • n=5 Participants

PRIMARY outcome

Timeframe: Change in Profile of Mood States Score from Baseline to 8 Weeks

Outcome measures

Outcome measures
Measure	DSL Workshop Participants n=12 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.
Change in Profile of Mood States Total Score.	4.5 units on a scale Standard Deviation 21.9

Adverse Events

DSL Workshop Participants

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DSL Workshop Participants n=13 participants at risk 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.
Psychiatric disorders suicidal ideations	7.7% 1/13 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Mitchel Turbin, PhD

VHAPORHCS

Phone: 503-220-8262

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place