Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04575051 |
| Other study ID # |
STUDY19120233 |
| Secondary ID |
HL-2019C1-16067 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
November 1, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
University of Pittsburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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:
1. allowing the clinical teams to roll out the intervention in a small number of facilities
in a timely, systematic manner (interventions are not part of the research protocol)
2. possibly increasing participation and buy-in since all facilities will eventually
implement the intervention during the study
3. possible increase in statistical power compared to a cluster randomized trial due to
increase in data collection and within cluster comparisons.
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.
