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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06468137
• Other study ID #: Uppföljning
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: Region Skane
• Contact: Sandra Ahlberg
• Phone: +4646172921
• Email: sandra.ahlberg[@]skane.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Deafness
• Hearing Disorders
• Hearing Impairment
• Hearing Loss

Intervention

Behavioral:
• Swedish I-ACE
Rehabilitative programme with focus on communication strategies and problem solving for people with hearing loss.
• Clinical visit
Visit in the clinic with focus on audiologic rehabilitation.

Other:
• No follow-up
Participants choosing no follow-up.

Locations

Country	Name	City	State
Sweden	Audiologimottagningen Lund	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Horselvarden Region Ostergotland

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Communication and Acceptance Scale (CAS)	Assessing changes in use of communication strategies and the emotional consequences, knowledge and acceptance of hearing loss.	Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
Secondary	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