Trial Outcomes & Findings for Clinical Trial of the "Living Well With Hearing Loss Workshop" (NCT NCT00323427)

Results Overview

The Communication Profile for Hearing Impaired (CPHI) queries subjects on how well they can communicate with others. The Maladaptive strategies subscale describe behaviors that prevent the individual from coping effectively with communication problems. 8 week change score from baseline value. Larger values of the change score indicate less use of maladaptive behaviors. Larger group mean change score indicates BETTER performance on this scale. CPHI Maladaptive strategies subscale ranges from 1 (better) to 5 (worse) maladaptive strategy usage.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

135 participants

Primary outcome timeframe

8 weeks post-baseline relative to baseline

Results posted on

2014-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Group Aural Rehabilitation Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator	Hearing Aids Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
Overall Study STARTED	69	66
Overall Study COMPLETED	38	43
Overall Study NOT COMPLETED	31	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial of the "Living Well With Hearing Loss Workshop"

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=69 Participants Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator	Arm 2 n=66 Participants Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services	Total n=135 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	20 Participants n=7 Participants	53 Participants n=5 Participants
Age, Categorical >=65 years	36 Participants n=5 Participants	46 Participants n=7 Participants	82 Participants n=5 Participants
Age, Continuous	67.0 years STANDARD_DEVIATION 9.8 • n=5 Participants	71.1 years STANDARD_DEVIATION 8.4 • n=7 Participants	69.0 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	69 Participants n=5 Participants	65 Participants n=7 Participants	134 Participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants	66 participants n=7 Participants	135 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks post-baseline relative to baseline

Population: Intent-to-treat (ITT)

The Communication Profile for Hearing Impaired (CPHI) queries subjects on how well they can communicate with others. The Maladaptive strategies subscale describe behaviors that prevent the individual from coping effectively with communication problems. 8 week change score from baseline value. Larger values of the change score indicate less use of maladaptive behaviors. Larger group mean change score indicates BETTER performance on this scale. CPHI Maladaptive strategies subscale ranges from 1 (better) to 5 (worse) maladaptive strategy usage.

Outcome measures

Outcome measures
Measure	Arm 1 n=57 Participants Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator	Arm 2 n=58 Participants Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
Communication Profile for Hearing Impaired: Maladaptive Strategies Subscale	0.33 score on a scale Standard Deviation 0.53	0.37 score on a scale Standard Deviation 0.51

PRIMARY outcome

Timeframe: 8 weeks post-baseline relative to baseline

Population: Intent to treat

The Communication Profile for Hearing Impaired (CPHI) queries subjects on how well they can communicate with others. The Verbal Strategies subscale describe adaptive strategies for coping with the effects of hearing impairment on communication. 8 week change score from baseline value. Larger values of the change score indicate more use of adaptive Verbal Strategies. Larger group mean change score indicates BETTER performance on this scale. CPHI Verbal Strategies scores vary from 1 (worse) to 5 (best) strategy usage.

Outcome measures

Outcome measures
Measure	Arm 1 n=57 Participants Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator	Arm 2 n=58 Participants Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
Communication Profile for Hearing Impaired: Verbal Strategies Subscale	-0.34 score on a scale Standard Deviation 0.79	-0.23 score on a scale Standard Deviation 0.67

PRIMARY outcome

Timeframe: 8-weeks post-baseline relative to baseline

Population: Intent-to-Treat

The Communication Profile for Hearing Impaired (CPHI) queries subjects on how well they can communicate with others. The Non-verbal Strategies subscale describe adaptive coping strategies but they describe unobtrusive, nonverbal behaviors that the individual can use to maximize communication effectiveness. 8 week change score from baseline value. Larger values of the change score indicate more use of adaptive non-verbal behaviors. Larger group mean change score indicates BETTER performance on this scale. The CPHI Non-verbal strategies score ranges from 1 (worse) to 5 (better) usage of non-verbal strategies.

Outcome measures

Outcome measures
Measure	Arm 1 n=57 Participants Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator	Arm 2 n=58 Participants Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
Communication Profile for Hearing Impaired : Non-verbal Strategies Subscale	-0.22 score on a scale. Standard Deviation 0.78	-0.22 score on a scale. Standard Deviation 0.83

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mitchel Turbin, Ph.D.

Portland VA Medical Center

Phone: 503-220-8262

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place