An interventional study of Consult Model and Engage Model in Hearing Loss, Age-Related, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Health services research
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.
The study is employing an open cohort stepped-wedge cluster randomized design with a phased, randomized roll out. The stepped wedge design is a useful design for the evaluation of complex health care interventions particularly when the intervention is believed to be beneficial with minimal risk. This design is increasingly being used to evaluate interventions involving health care delivery and has several advantages:
Our intervention is applied at the facility level (cluster) but the primary outcomes are obtained at the resident level. In this open cohort design, all residents in a facility are identified to participate but some may leave the facility and others will move into the facility over the course of the study. The interventions are standard care at UPMC and are at the facility and individual level regardless of participation in the research project by any individual.
The 10 facilities participating in the study all currently receive the Consult Model of care. These same facilities are targeted to receive the Engage Model of care over the next three years as part of the standard care in these facilities. Residents enrolled in the study during any time period will be followed until the end of the study or until they are no longer a resident of the facility, whichever comes first. This implies that crossover to the intervention is not only at the facility level but also the resident level. Once the intervention is available at a facility, residents will be exposed to the intervention continuously regardless of enrollment for the study measures. The resident level outcomes of satisfaction with social participation and hearing-specific HRQoL will be measured every 5 months for the duration of the study. In addition, staff satisfaction and family burden will be surveyed every 5 months.
NOTE: The clinicaltrials.gov record was updated after data collection ended to correct the study arms and interventions. The study arms were originally and incorrectly documented in clinicaltrials.gov as the resident, caregiver, and staff cohorts rather than the interventions.
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This study's enrollment of 684 is above the median of 60 across 45 interventional studies indexed under Presbycusis.
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Exclusion Criteria:
Residents will be exposed to the Consult Model and the Engage Model.
Other: Consult Model · Other: Engage Model
The Consult Model (i.e., usual care) is an acute care strategy, relying on a monthly Audiologist visit to the facility.
Other: Consult Model
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 supportive 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.
Satisfaction With Social Participation
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).
Time frame: Baseline (T0), at 5 (T1), 10 (T2), 15 (T3), 20 (T4) and 25 (T5) months
Hearing-Specific Health-Related Quality of Life
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.
Time frame: Baseline, at 5, 10, 15, 20 and 25 months
Family Burden
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.
Time frame: Baseline, at 5, 10, 15, 20 and 25 months
Staff Satisfaction
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.
Time frame: Baseline, at 5, 10, 15, 20 and 25 months
The study was an open cohort stepped wedge design with continuous recruitment and enrollment. Residents were enrolled at Time Period 0 but could be enrolled at any time period of the study due to being a new resident of the facility or being interested at the time period they were approached. The protocol enrollment reflects the total number enrolled at all 10 facilities across 6 time points (Time Periods 0-5).
| Milestone | Group 1 (HearCARE Start at T1) | Group 2 (HearCARE Start at T2) | Group 3 (HearCARE Start at T3) | Group 4 (HearCARE Start at T4) | Group 5 (HearCARE Start at T5) |
|---|---|---|---|---|---|
| Started | 62 | 55 | 87 | 77 | 44 |
| Completed | 47 | 49 | 68 | 68 | 36 |
| Not completed | 15 | 6 | 19 | 9 | 8 |
| Withdrew: Discontinued due to death or moving to higher level of care | 15 | 6 | 19 | 9 | 8 |
| Milestone | Group 1 (HearCARE Start at T1) | Group 2 (HearCARE Start at T2) | Group 3 (HearCARE Start at T3) | Group 4 (HearCARE Start at T4) | Group 5 (HearCARE Start at T5) |
|---|---|---|---|---|---|
| Started | 69 | 84 | 89 | 87 | 58 |
| Completed | 55 | 67 | 79 | 69 | 42 |
| Not completed | 14 | 17 | 10 | 18 | 16 |
| Withdrew: Missing follow up | 1 | 3 | 1 | 3 | 2 |
| Withdrew: Discontinued due to death or moving to higher level of care | 13 | 14 | 9 | 15 | 14 |
| Milestone | Group 1 (HearCARE Start at T1) | Group 2 (HearCARE Start at T2) | Group 3 (HearCARE Start at T3) | Group 4 (HearCARE Start at T4) | Group 5 (HearCARE Start at T5) |
|---|---|---|---|---|---|
| Started | 75 | 75 | 99 | 80 | 51 |
| Completed | 59 | 59 | 72 | 65 | 42 |
| Not completed | 16 | 16 | 27 | 15 | 9 |
| Withdrew: Missing follow up | 1 | 8 | 7 | 0 | 1 |
| Withdrew: Discontinued due to death or moved to higher level of care | 15 | 8 | 20 | 15 | 8 |
| Milestone | Group 1 (HearCARE Start at T1) | Group 2 (HearCARE Start at T2) | Group 3 (HearCARE Start at T3) | Group 4 (HearCARE Start at T4) | Group 5 (HearCARE Start at T5) |
|---|---|---|---|---|---|
| Started | 87 | 82 | 96 | 65 | 56 |
| Completed | 74 | 72 | 81 | 59 | 53 |
| Not completed | 13 | 10 | 15 | 6 | 3 |
| Withdrew: Missing follow up | 8 | 6 | 4 | 3 | 0 |
| Withdrew: Discontinued due to death or moved to higher level of care | 5 | 4 | 11 | 3 | 3 |
| Milestone | Group 1 (HearCARE Start at T1) | Group 2 (HearCARE Start at T2) | Group 3 (HearCARE Start at T3) | Group 4 (HearCARE Start at T4) | Group 5 (HearCARE Start at T5) |
|---|---|---|---|---|---|
| Started | 96 | 92 | 100 | 70 | 62 |
| Completed | 77 | 86 | 87 | 67 | 52 |
| Not completed | 19 | 6 | 13 | 3 | 10 |
| Withdrew: Missing follow up | 17 | 3 | 4 | 2 | 1 |
| Withdrew: Discontinued due to death or moved to higher level of care | 2 | 3 | 9 | 1 | 9 |
| Milestone | Group 1 (HearCARE Start at T1) | Group 2 (HearCARE Start at T2) | Group 3 (HearCARE Start at T3) | Group 4 (HearCARE Start at T4) | Group 5 (HearCARE Start at T5) |
|---|---|---|---|---|---|
| Started | 112 | 98 | 97 | 80 | 59 |
| Completed | 101 | 90 | 85 | 77 | 48 |
| Not completed | 11 | 8 | 12 | 3 | 11 |
| Withdrew: Missing follow up | 11 | 8 | 12 | 3 | 11 |
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).
| T-score | Group 1 (HearCARE Start at T1) | Group 2 (HearCARE Start at T2) | Group 3 (HearCARE Start at T3) | Group 4 (HearCARE Start at T4) | Group 5 (HearCARE Start at T5) |
|---|---|---|---|---|---|
| Baseline (Time 0) | 49.7 ± 7.9 | 52.8 ± 8.9 | 51.2 ± 10.3 | 49.4 ± 6.6 | 51.7 ± 7.6 |
| 5 months (Time 1) | 49.7 ± 7.8 | 48.4 ± 6.7 | 47.6 ± 8.7 | 48.1 ± 5.6 | 48.1 ± 7.0 |
| 10 months (Time 2) | 48.1 ± 7.1 | 47.6 ± 6.1 | 49.4 ± 7.0 | 48.6 ± 7.0 | 47.4 ± 6.0 |
| 15 months (Time 3) | 52.0 ± 7.1 | 47.1 ± 6.5 | 45.4 ± 6.2 | 49.9 ± 8.1 | 48.4 ± 6.6 |
| 20 months (Time 4) | 49.4 ± 5.6 | 49.0 ± 7.1 | 47.2 ± 6.3 | 48.1 ± 6.8 | 48.2 ± 6.4 |
| 25 months (Time 5) | 49.1 ± 7.3 | 48.2 ± 7.8 | 49.6 ± 8.2 | 47.4 ± 7.2 | 48.9 ± 6.7 |
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.
| score on a scale | Group 1 (HearCARE Start at T1) | Group 2 (HearCARE Start at T2) | Group 3 (HearCARE Start at T3) | Group 4 (HearCARE Start at T4) | Group 5 (HearCARE Start at T5) |
|---|---|---|---|---|---|
| Baseline (Time 0) | 10.2 ± 11.2 | 10.6 ± 9.6 | 9.2 ± 10.2 | 7.5 ± 8.9 | 8.1 ± 9.4 |
| 5 months (Time 1) | 9.4 ± 9.6 | 10.9 ± 10.1 | 9.4 ± 9.2 | 9.2 ± 10.9 | 8.9 ± 9.1 |
| 10 months (Time 2) | 8.9 ± 8.8 | 11.6 ± 10.2 | 8.9 ± 8.5 | 9.2 ± 9.0 | 5.6 ± 7.0 |
| 15 months (Time 3) | 7.3 ± 8.9 | 9.8 ± 10.0 | 9.5 ± 9.2 | 10.1 ± 9.5 | 6.7 ± 8.5 |
| 20 months (Time 4) | 6.9 ± 8.3 | 8.5 ± 8.3 | 7.9 ± 7.7 | 9.7 ± 8.9 | 7.0 ± 8.8 |
| 25 months (Time 5) | 9.0 ± 11.0 | 8.5 ± 10.0 | 4.4 ± 5.0 | 6.9 ± 8.5 | 5.6 ± 8.6 |
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.
| score on a scale | Group 1 (HearCARE Start at T1) | Group 2 (HearCARE Start at T2) | Group 3 (HearCARE Start at T3) | Group 4 (HearCARE Start at T4) | Group 5 (HearCARE Start at T5) |
|---|---|---|---|---|---|
| Baseline (Time 0) | 5.5 ± 3.7 | 4.4 ± 3.4 | 5.4 ± 3.0 | 4.7 ± 3.6 | 4.9 ± 3.0 |
| 5 months (Time 1) | 3.6 ± 2.8 | 3.9 ± 2.9 | 4.5 ± 3.1 | 4.2 ± 3.7 | 4.6 ± 3.4 |
| 10 months (Time 2) | 3.9 ± 2.8 | 6.7 ± 4.4 | 5.6 ± 3.3 | 4.8 ± 3.7 | 4.8 ± 3.8 |
| 15 months (Time 3) | 5.1 ± 3.7 | 5.2 ± 4.6 | 5.4 ± 3.0 | 4.1 ± 3.8 | 5.0 ± 4.8 |
| 20 months (Time 4) | 4.8 ± 2.8 | 3 ± 2.8 | 5.9 ± 3.7 | 5.0 ± 3.5 | 5.3 ± 3.9 |
| 25 months (Time 5) | 5.1 ± 2.7 | 4.3 ± 4.0 | 5.4 ± 2.8 | 4.6 ± 3.9 | 4.4 ± 3.6 |
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.
| score on a scale | Group 1 (HearCARE Start at T1) | Group 2 (HearCARE Start at T2) | Group 3 (HearCARE Start at T3) | Group 4 (HearCARE Start at T4) | Group 5 (HearCARE Start at T5) |
|---|---|---|---|---|---|
| Baseline (Time 0) | 2.1 ± 1.0 | 1.3 ± 0.5 | 1.6 ± 0.8 | 2.1 ± 1.0 | 1.8 ± 0.6 |
| 5 months (Time 1) | 1.9 ± 1.0 | 1.9 ± 0.8 | 1.6 ± 0.7 | 1.8 ± 0.9 | 1.8 ± 0.7 |
| 10 months (Time 2) | 1.7 ± 0.8 | 1.1 ± 0.3 | 2.2 ± 1.2 | 1.4 ± 0.5 | 1.7 ± 0 |
| 15 months (Time 3) | 1.8 ± 0.8 | 1.3 ± 0.6 | 2.0 ± 1.0 | 1.7 ± 0.8 | 2.1 ± 0.9 |
| 20 months (Time 4) | 1.8 ± 1.1 | 1.5 ± 0.8 | 1.9 ± 1.1 | 1.4 ± 0.6 | 1.8 ± 0.8 |
| 25 months (Time 5) | 1.6 ± 0.8 | 1.4 ± 0.7 | 1.7 ± 0.7 | 1.4 ± 0.5 | 1.9 ± 0.8 |
Collected over 25 months from study start (Time Point 0 through Time Point 5). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 (2 Residential Facilities) | 25/162 (15.4%) | — | — |
| Group 2 (2 Residential Facilities) | 23/133 (17.3%) | — | — |
| Group 3 (2 Residential Facilities) | 53/165 (32.1%) | — | — |
| Group 4 (2 Residential Facilities) | 20/123 (16.3%) | — | — |
| Group 5 (2 Residential Facilities) | 24/101 (23.8%) | — | — |
Residents who were ever enrolled into the study over the all time periods (Time Period 0 through Time Period 5) of the stepped wedge cluster randomized trial.
| Age, Continuous(years) | Group 1 (HearCARE Start T1) | Group 2 (HearCARE Start T2) | Group 3 (HearCARE Start T3) | Group 4 (HearCARE Start T4) | Group 5 (HearCARE Start T5) | Total |
|---|---|---|---|---|---|---|
| Mean | 89.3 ± 7.8 | 87.8 ± 7.1 | 87.3 ± 8.3 | 89.0 ± 8.4 | 83.8 ± 8.6 | 87.7 ± 8.2 |
| Sex: Female, Male(Participants) | Group 1 (HearCARE Start T1) | Group 2 (HearCARE Start T2) | Group 3 (HearCARE Start T3) | Group 4 (HearCARE Start T4) | Group 5 (HearCARE Start T5) | Total |
|---|---|---|---|---|---|---|
| Female | 123 | 96 | 126 | 89 | 61 | 495 |
| Male | 39 | 37 | 39 | 34 | 40 | 189 |
| Ethnicity (NIH/OMB)(Participants) | Group 1 (HearCARE Start T1) | Group 2 (HearCARE Start T2) | Group 3 (HearCARE Start T3) | Group 4 (HearCARE Start T4) | Group 5 (HearCARE Start T5) | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 0 | 0 | 0 | 1 |
| Not Hispanic or Latino | 161 | 133 | 165 | 123 | 101 | 683 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(participants) | Group 1 (HearCARE Start T1) | Group 2 (HearCARE Start T2) | Group 3 (HearCARE Start T3) | Group 4 (HearCARE Start T4) | Group 5 (HearCARE Start T5) | Total |
|---|---|---|---|---|---|---|
| White | 155 | 120 | 160 | 116 | 92 | 643 |
| Not White | 4 | 6 | 3 | 2 | 0 | 15 |
| Not Reported | 3 | 7 | 2 | 5 | 9 | 26 |
| Region of Enrollment(participants) | Group 1 (HearCARE Start T1) | Group 2 (HearCARE Start T2) | Group 3 (HearCARE Start T3) | Group 4 (HearCARE Start T4) | Group 5 (HearCARE Start T5) | Total |
|---|---|---|---|---|---|---|
| United States | 162 | 133 | 165 | 123 | 101 | 684 |
| Hearing Handicap Inventory at Enrollment(units on a scale) | Group 1 (HearCARE Start T1) | Group 2 (HearCARE Start T2) | Group 3 (HearCARE Start T3) | Group 4 (HearCARE Start T4) | Group 5 (HearCARE Start T5) | Total |
|---|---|---|---|---|---|---|
| Mean | 8.2 ± 9.2 | 9.0 ± 9.0 | 8.6 ± 8.9 | 8.0 ± 9.5 | 6.5 ± 8.4 | 8.2 ± 9.0 |
| PROMIS Participation at Enrollment(T-score) | Group 1 (HearCARE Start T1) | Group 2 (HearCARE Start T2) | Group 3 (HearCARE Start T3) | Group 4 (HearCARE Start T4) | Group 5 (HearCARE Start T5) | Total |
|---|---|---|---|---|---|---|
| Mean | 49.4 ± 7.1 | 50.6 ± 8.1 | 49.9 ± 8.8 | 48.1 ± 7.2 | 49.8 ± 7.3 | 49.6 ± 7.8 |
| Pure tone average right side(decibels) | Group 1 (HearCARE Start T1) | Group 2 (HearCARE Start T2) | Group 3 (HearCARE Start T3) | Group 4 (HearCARE Start T4) | Group 5 (HearCARE Start T5) | Total |
|---|---|---|---|---|---|---|
| Mean | 43.5 ± 14.2 | 47.0 ± 15.8 | 44.1 ± 17.5 | 47.6 ± 17.0 | 39.5 ± 14.0 | 44.0 ± 15.9 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified data, including protocol, statistical analysis and full data set may be shared with investigators conducting similar research or for educational purposes. No identifiable data will be shared.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data will become available after the conclusion of the study and will be available
Access criteria: Access to the data will be determined by the PIs and funding agency (PCORI). Requests for the data can be made to them and will be considered before dissemination.
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