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Enrolling by Invitation

NCT Number: NCT06468137

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

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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Audiologimottagningen Lund

Lund, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Swedish I-ACE

Behavioral

Rehabilitative programme with focus on communication strategies and problem solving for people with hearing loss.

Clinical visit

Behavioral

Visit in the clinic with focus on audiologic rehabilitation.

No follow-up

Other

Participants choosing no follow-up.

Primary outcomes

  1. The Hearing Handicap Inventory for the Elderly (HHIE)

    Time frame: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention

    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.

Secondary outcomes

  1. The 12-item Speech, Spatial and Qualities of Hearing Scale (SSQ12)

    Time frame: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention

    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.

  2. Communication Strategies Scale (CSS)

    Time frame: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention

    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.

  3. The International Outcome Inventory for Hearing Aids (IOI-HA)

    Time frame: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention

    Assessing changes in perceived effectiveness and satisfaction with hearing aids.

    Minimum 7 points to maximum 35 points. Higher score indicates higher perceived effect.

  4. Communication and Acceptance Scale (CAS)

    Time frame: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention

    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.

  5. The International Outcome Inventory for Alternative Interventions (IOI-AI)

    Time frame: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention

    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.

Other outcomes

  1. Subjective impact of the intervention, reported by the users: Memory of the intervention

    Time frame: Time Frame: 6 months post intervention

    The participants are asked what they remember from their intervention.

  2. Subjective impact of the intervention, reported by the users: Seeking more or other information

    Time frame: Time Frame: 6 months post intervention

    The participants are asked if they searched for more or other information about hearing or hearing aids.

  3. Subjective impact of the intervention, reported by the users: Adverse effects

    Time frame: Time Frame: 6 months post intervention

    The participants are asked if they experienced any adverse effects of the intervention.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Horselvarden Region Ostergotland

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 21, 2024
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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