Hearing for Communication and Resident Engagement

NCT04575051 | Completed Results DMC

• 2 other identifiers: STUDY19120233HL-2019C1-16067
• Study Type: interventional
• Target: 684
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hearing Loss, Age-Related

Keywords

hearing loss, communication, social participation

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  Baseline, at 5, 10, 15, 20 and 25 months

Secondary Outcomes (2)

• Family Burden

  Baseline, at 5, 10, 15, 20 and 25 months

• Staff Satisfaction

  Baseline, at 5, 10, 15, 20 and 25 months

Study Arms (2)

HearCARE (Consult+Engage)

ACTIVE COMPARATOR

Residents will be exposed to the Consult Model and the Engage Model.

Other: Consult Model; Other: Engage Model

Consult Model

OTHER

The Consult Model (i.e., usual care) is an acute care strategy, relying on a monthly Audiologist visit to the facility.

Other: Consult Model

Interventions

Consult Model OTHER

The Consult Model (i.e., usual care) is an acute care strategy, relying on a monthly Audiologist visit to the facility.

Consult Model; HearCARE (Consult+Engage)

Engage Model OTHER

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.

HearCARE (Consult+Engage)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to participate and
• Being a resident, staff member or family member of a resident at one of the participating Assisted Living/Personal Care Facilities.

You may not qualify if:

• Unwillingness to participate
• Not being a Resident, staff member or family member of a resident at one of eight Assisted Living/Personal Care Facilities.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Presbycusis; Hearing Loss; Communication

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Dr. Catherine Palmer
• Organization: University of Pittsburgh

cvp@pitt.edu

412-383-6565

Study Officials

• Catherine Palmer, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data collectors will be masked to which phase the facility is in.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Open cohort stepped-wedge cluster randomized design with a phased, randomized roll out

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 5, 2020
• Study Start: June 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: December 13, 2024
• Results First Posted: December 13, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.

Locations

US (1)