Clinically Implementing Online Hearing Support Within Hearing Organization

NCT03687801 | Completed

• 1 other identifier: e-Hearing
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Previous research has proposed employing telehealth in hearing healthcare to improve clinical care and increase access to hearing services. Several studies have shown that hearing support can be carried out without in-person meetings and lead to significant benefits for hearing aid users. Interventions for persons with hearing impairment improve communication and improve outcomes more than hearing aid use alone. The first purpose of this study is needs-oriented and the second purpose is research-oriented. The needs-oriented purpose of this project is to, via a national website of health information and services for Sweden, provide needed online support to hearing aid users. The research-oriented purpose of this project is to document the effectiveness of the online support compared to traditional support that the Hearing Organization, provides ("standard care").

Conditions

Hearing Impairment

Keywords

audiologic rehabilitation; hearing loss; patient education; patient participation; structured rehabilitation; internet interventions; counseling

Outcome Measures

Primary Outcomes (1)

• Change is assessed for the Hearing Handicap Inventory for the Elderly (HHIE)

  The HHIE measures the experience of hearing loss in older people by focusing on the psychosocial and emotional effects of hearing loss. Higher score reflects a higher self-reported hearing problem. Minimum score for the total scale (reported) is 0 and maximum score is 100 points.

  change from baseline HHIE at 5 weeks, change from baseline HHIE at 6 months, change from baseline HHIE at 1 year

Secondary Outcomes (1)

• Change is assessed for the Communication Strategies Scale (CSS)

  change from baseline CSS at 5 weeks, change from baseline CSS at 6 months, change from baseline CSS at 1 year

Study Arms (2)

Online hearing support

EXPERIMENTAL

The intervention group will have access to online hearing support for five weeks. The online hearing support will include a program that consists of three elements: 1) reading material; 2) reading instructions and weekly assignments related to the reading material; and 3) online and telephone interaction with a professional.

Behavioral: Online hearing support

Standard care

ACTIVE COMPARATOR

The control group will have access to traditional support that the Hearing Organization provides ("standard care").

Behavioral: Standard care

Interventions

Online hearing support BEHAVIORAL

The intervention group will follow an online hearing support for five weeks

Online hearing support

Standard care BEHAVIORAL

The control group will follow standard care during the time the intervention group receives online haring support

Standard care

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the hearing aid users to be 20 yr of age or above,
• the hearing aid users to have completed a hearing aid fitting at least 3 months before the study began (regardless of hearing aid manufacturer, model, or hearing aid outcomes),
• the hearing aid users to have a Hearing Handicap Inventory for the Elderly (HHIE) score of \>20 points (indicative of some residual self-reported hearing problems).

You may not qualify if:

• the hearing aid users who are not fulfilling the conditions to participate.

Sponsors & Collaborators

• Sodra Alvsborgs Hospital: lead

Study Sites (1)

Hearing Clinic, Hearing Organization

Borås, Vastra Gotalandsregion, 501 82, Sweden

Location

MeSH Terms

Conditions

Hearing Loss; Patient Participation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Milijana Malmberg, PhD

  Hörselverksamheten, Habilitering & Hälsa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 27, 2018
• Study Start: September 24, 2018
• Primary Completion: August 16, 2019
• Study Completion: August 16, 2019
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)