60 and older, any sex, with Hearing Loss, Age-Related. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Satisfaction With Social ParticipationPrimary· Baseline (T0), at 5 (T1), 10 (T2), 15 (T3), 20 (T4) and 25 (T5) months
PROMIS Satisfaction with Participation in Discretionary Social Activities SF7a self-reported contentment with leisure interests and relationships with friends. T- scores are provided ranging from 27 to 65.6 where higher scores indicate more satisfaction (50 indicates the population mean with a standard deviation of 10).
Baseline (Time 0)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
49.7
± 7.9
Group 2 (HearCARE Start at T2)
52.8
± 8.9
Group 3 (HearCARE Start at T3)
51.2
± 10.3
Group 4 (HearCARE Start at T4)
49.4
± 6.6
Group 5 (HearCARE Start at T5)
51.7
± 7.6
5 months (Time 1)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
49.7
± 7.8
Group 2 (HearCARE Start at T2)
48.4
± 6.7
Group 3 (HearCARE Start at T3)
47.6
± 8.7
Group 4 (HearCARE Start at T4)
48.1
± 5.6
Group 5 (HearCARE Start at T5)
48.1
± 7.0
10 months (Time 2)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
48.1
± 7.1
Group 2 (HearCARE Start at T2)
47.6
± 6.1
Group 3 (HearCARE Start at T3)
49.4
± 7.0
Group 4 (HearCARE Start at T4)
48.6
± 7.0
Group 5 (HearCARE Start at T5)
47.4
± 6.0
15 months (Time 3)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
52.0
± 7.1
Group 2 (HearCARE Start at T2)
47.1
± 6.5
Group 3 (HearCARE Start at T3)
45.4
± 6.2
Group 4 (HearCARE Start at T4)
49.9
± 8.1
Group 5 (HearCARE Start at T5)
48.4
± 6.6
20 months (Time 4)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
49.4
± 5.6
Group 2 (HearCARE Start at T2)
49.0
± 7.1
Group 3 (HearCARE Start at T3)
47.2
± 6.3
Group 4 (HearCARE Start at T4)
48.1
± 6.8
Group 5 (HearCARE Start at T5)
48.2
± 6.4
25 months (Time 5)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
49.1
± 7.3
Group 2 (HearCARE Start at T2)
48.2
± 7.8
Group 3 (HearCARE Start at T3)
49.6
± 8.2
Group 4 (HearCARE Start at T4)
47.4
± 7.2
Group 5 (HearCARE Start at T5)
48.9
± 6.7
Hearing-Specific Health-Related Quality of LifePrimary· Baseline, at 5, 10, 15, 20 and 25 months
Hearing Handicap Inventory for the Elderly captures social and emotional hearing handicap. 10 items with responses scored 0, 2, and 4 for 'No', 'Sometimes', and 'Yes'; min total score is 0 and maximum is 40. Higher scores indicate worse impact of hearing difficulties on activities and participation.
Baseline (Time 0)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
10.2
± 11.2
Group 2 (HearCARE Start at T2)
10.6
± 9.6
Group 3 (HearCARE Start at T3)
9.2
± 10.2
Group 4 (HearCARE Start at T4)
7.5
± 8.9
Group 5 (HearCARE Start at T5)
8.1
± 9.4
5 months (Time 1)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
9.4
± 9.6
Group 2 (HearCARE Start at T2)
10.9
± 10.1
Group 3 (HearCARE Start at T3)
9.4
± 9.2
Group 4 (HearCARE Start at T4)
9.2
± 10.9
Group 5 (HearCARE Start at T5)
8.9
± 9.1
10 months (Time 2)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
8.9
± 8.8
Group 2 (HearCARE Start at T2)
11.6
± 10.2
Group 3 (HearCARE Start at T3)
8.9
± 8.5
Group 4 (HearCARE Start at T4)
9.2
± 9.0
Group 5 (HearCARE Start at T5)
5.6
± 7.0
15 months (Time 3)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
7.3
± 8.9
Group 2 (HearCARE Start at T2)
9.8
± 10.0
Group 3 (HearCARE Start at T3)
9.5
± 9.2
Group 4 (HearCARE Start at T4)
10.1
± 9.5
Group 5 (HearCARE Start at T5)
6.7
± 8.5
20 months (Time 4)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
6.9
± 8.3
Group 2 (HearCARE Start at T2)
8.5
± 8.3
Group 3 (HearCARE Start at T3)
7.9
± 7.7
Group 4 (HearCARE Start at T4)
9.7
± 8.9
Group 5 (HearCARE Start at T5)
7.0
± 8.8
25 months (Time 5)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
9.0
± 11.0
Group 2 (HearCARE Start at T2)
8.5
± 10.0
Group 3 (HearCARE Start at T3)
4.4
± 5.0
Group 4 (HearCARE Start at T4)
6.9
± 8.5
Group 5 (HearCARE Start at T5)
5.6
± 8.6
Family BurdenSecondary· Baseline, at 5, 10, 15, 20 and 25 months
Zarit Burden Interview is a 4-item questionnaire that measures caregiver burden. The 4 items each have responses ranging from 0='Never' to 4='Nearly Always'. Item responses are summed to produce the total score that ranges from 0 to 16 with higher scores indicating more burden.
Baseline (Time 0)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
5.5
± 3.7
Group 2 (HearCARE Start at T2)
4.4
± 3.4
Group 3 (HearCARE Start at T3)
5.4
± 3.0
Group 4 (HearCARE Start at T4)
4.7
± 3.6
Group 5 (HearCARE Start at T5)
4.9
± 3.0
5 months (Time 1)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
3.6
± 2.8
Group 2 (HearCARE Start at T2)
3.9
± 2.9
Group 3 (HearCARE Start at T3)
4.5
± 3.1
Group 4 (HearCARE Start at T4)
4.2
± 3.7
Group 5 (HearCARE Start at T5)
4.6
± 3.4
10 months (Time 2)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
3.9
± 2.8
Group 2 (HearCARE Start at T2)
6.7
± 4.4
Group 3 (HearCARE Start at T3)
5.6
± 3.3
Group 4 (HearCARE Start at T4)
4.8
± 3.7
Group 5 (HearCARE Start at T5)
4.8
± 3.8
15 months (Time 3)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
5.1
± 3.7
Group 2 (HearCARE Start at T2)
5.2
± 4.6
Group 3 (HearCARE Start at T3)
5.4
± 3.0
Group 4 (HearCARE Start at T4)
4.1
± 3.8
Group 5 (HearCARE Start at T5)
5.0
± 4.8
20 months (Time 4)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
4.8
± 2.8
Group 2 (HearCARE Start at T2)
3
± 2.8
Group 3 (HearCARE Start at T3)
5.9
± 3.7
Group 4 (HearCARE Start at T4)
5.0
± 3.5
Group 5 (HearCARE Start at T5)
5.3
± 3.9
25 months (Time 5)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
5.1
± 2.7
Group 2 (HearCARE Start at T2)
4.3
± 4.0
Group 3 (HearCARE Start at T3)
5.4
± 2.8
Group 4 (HearCARE Start at T4)
4.6
± 3.9
Group 5 (HearCARE Start at T5)
4.4
± 3.6
Staff SatisfactionSecondary· Baseline, at 5, 10, 15, 20 and 25 months
Michigan Organizational Assessment Questionnaire (MOAQ) is a 3-item questionnaire that measures satisfaction with one's job. Items have responses ranging from 1='Agree Strongly' to 6='Disagree Strongly'. The combined score is the average of the 3 items with one item reverse scored. Higher scores indicate less satisfaction.
Baseline (Time 0)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
2.1
± 1.0
Group 2 (HearCARE Start at T2)
1.3
± 0.5
Group 3 (HearCARE Start at T3)
1.6
± 0.8
Group 4 (HearCARE Start at T4)
2.1
± 1.0
Group 5 (HearCARE Start at T5)
1.8
± 0.6
5 months (Time 1)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
1.9
± 1.0
Group 2 (HearCARE Start at T2)
1.9
± 0.8
Group 3 (HearCARE Start at T3)
1.6
± 0.7
Group 4 (HearCARE Start at T4)
1.8
± 0.9
Group 5 (HearCARE Start at T5)
1.8
± 0.7
10 months (Time 2)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
1.7
± 0.8
Group 2 (HearCARE Start at T2)
1.1
± 0.3
Group 3 (HearCARE Start at T3)
2.2
± 1.2
Group 4 (HearCARE Start at T4)
1.4
± 0.5
Group 5 (HearCARE Start at T5)
1.7
± 0
15 months (Time 3)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
1.8
± 0.8
Group 2 (HearCARE Start at T2)
1.3
± 0.6
Group 3 (HearCARE Start at T3)
2.0
± 1.0
Group 4 (HearCARE Start at T4)
1.7
± 0.8
Group 5 (HearCARE Start at T5)
2.1
± 0.9
20 months (Time 4)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
1.8
± 1.1
Group 2 (HearCARE Start at T2)
1.5
± 0.8
Group 3 (HearCARE Start at T3)
1.9
± 1.1
Group 4 (HearCARE Start at T4)
1.4
± 0.6
Group 5 (HearCARE Start at T5)
1.8
± 0.8
25 months (Time 5)
Group
Value
95% CI
Group 1 (HearCARE Start at T1)
1.6
± 0.8
Group 2 (HearCARE Start at T2)
1.4
± 0.7
Group 3 (HearCARE Start at T3)
1.7
± 0.7
Group 4 (HearCARE Start at T4)
1.4
± 0.5
Group 5 (HearCARE Start at T5)
1.9
± 0.8
Sponsor's own description
Amplification is a well-established, evidence-based front-line treatment for those with impaired communication secondary to Age Related Hearing Loss (ARHL). ARHL is the most prevalent cause of communication impairment among older adults. The challenge in treating ARHL is identifying a care model that effectively promotes adherence to individualized-treatment recommendations allowing the end-user to self-manage hearing loss with appropriate support. This proposal compares the two most common models of care for ARHL provided to adults in assisted living/personal care communities. The Consult Model (i.e., usual care) is an acute care strategy, relying on a monthly Audiologist visit to the facility.
The Engage Model is a chronic care approach to support hearing loss self-management of ARHL. Engage includes (a) hearing screening for all residents, (b) an individualized communication plan for those with an identified hearing loss (e.g., one-to-one, group, telephone, television plans, hearing aid trouble shooting, communication strategies, etc.), (c) provision of simple, non-custom amplifiers, (d) referral to audiology if needed, and (e) ongoing support provided by trained personnel (Communication Facilitator) under the supervision of the audiologist.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Pittsburgh
Last refreshed: 13 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04575051.