Follow Up of an Online Hearing Support for First-time Hearing Aid Users

Follow Up of an Online Hearing Support for First-time Hearing Aid Users Using the Swedish I-ACE, Clinical Visit or Nothing

The main questions the research aims to answer are short- and long-term effects on consequences of hearing loss depending on which type of follow-up the participant chooses.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hearing Loss; Hearing Disorders; Hearing Impairment
• Intervention / Treatment: Behavioral: Swedish I-ACE; Behavioral: Clinical visit; Other: No follow-up

Detailed Description

Investigation of the emotional and social consequences of hearing loss that the participants experience, use of communications strategies, experienced listening in complex sound environments and perceived effectiveness and satisfaction with hearing aids. The goal is also to assess changes in use of communication strategies and the emotional consequences, knowledge and acceptance of hearing loss.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden
    • Audiologimottagningen Lund

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• People who have participated in NCT06051968 are automatically enrolled to participate in the follow-up according to the study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Swedish I-ACE; Participants choosing to take part in the Swedish I-ACE as follow-up.	Behavioral: Swedish I-ACE; Rehabilitative programme with focus on communication strategies and problem solving for people with hearing loss.
Other: Clinical visit; Participants choosing a clinical visit as follow-up.	Behavioral: Clinical visit; Visit in the clinic with focus on audiologic rehabilitation.
Other: No follow-up; Participants choosing no follow-up.	Other: No follow-up; Participants choosing no follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Hearing Handicap Inventory for the Elderly (HHIE)	Assessing changes in emotional and social effects of hearing loss, self-perceived activity limitations and participation restrictions. Minimum 0 points to maximum 100 points. Higher score indicates greater emotional and social effects of hearing loss.	Baseline, about 7 weeks post choice of intervention, and 6 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 12-item Speech, Spatial and Qualities of Hearing Scale (SSQ12)	Assessing experience of listening in complex sound environments. Minimum 0 points to 120 points. Higher score indicates less problems with hearing in the specified situations.	Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
Communication Strategies Scale (CSS)	Assessing changes in use of verbal, non-verbal and maladaptive communication strategies. Minimum 25 points to maximum 125 points. Higher score indicates a greater use of communication strategies.	Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
The International Outcome Inventory for Hearing Aids (IOI-HA)	Assessing changes in perceived effectiveness and satisfaction with hearing aids. Minimum 7 points to maximum 35 points. Higher score indicates higher perceived effect.	Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
The International Outcome Inventory for Alternative Interventions (IOI-AI)	Assessing changes in perceived effectiveness and satisfaction with an alternative intervention, in this case the Swedish I-ACE. Minimum 7 points to maximum 35 points. Higher score indicates higher perceived effect.	Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
Communication and Acceptance Scale (CAS)	Assessing changes in use of communication strategies and the emotional consequences, knowledge and acceptance of hearing loss. Minimum 18 points to maximum 90. Higher score indicates a lower impact of the hearing loss.	Baseline, about 7 weeks post choice of intervention, and 6 months post intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective impact of the intervention, reported by the users: Memory of the intervention	The participants are asked what they remember from their intervention.	Time Frame: 6 months post intervention
Subjective impact of the intervention, reported by the users: Seeking more or other information	The participants are asked if they searched for more or other information about hearing or hearing aids.	Time Frame: 6 months post intervention
Subjective impact of the intervention, reported by the users: Adverse effects	The participants are asked if they experienced any adverse effects of the intervention.	Time Frame: 6 months post intervention

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Horselvarden Region Ostergotland
• Investigators: Principal Investigator: Marie Öberg, Horselvarden Region Ostergotland

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 10, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Loss; Deafness; Hearing Disorders
• Other Study ID Numbers: Uppföljning

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No