Effect of Psycho-Educational Interventions in Communication Partners of Older Adults With Hearing Impairment
The Effectiveness of Group-based Multi-Component Psycho-Educational Interventions (GMC-PEIs) on Burden, Depression, Coping and Quality of Life in Communication Partners of Older Adults With Hearing Impairment
1 other identifier
interventional
92
1 country
1
Brief Summary
Hearing impairment is a critical health problem throughout the world. In addition, having an impact on the biopsychosocial functioning of older adults, it places enormous stress and burden on communication partners who interact with older adults with hearing impairment every day. These communication partners generally have restrictions to their social lives and an increased communication burden, as well as symptoms of depression and adopting maladaptive coping and poorer quality of life. Therefore, group-based multi-component psycho-educational interventions are recommended. The purposes of this study are to examine the effects of group-based multi-component psycho-educational interventions (GMC-PEIs) on burden, depression, coping and quality of life in communication partners of older adults with hearing impairment. The single-blind, randomized control trial will include communication partners of older adults with hearing impairment. Participants will be randomized to either intervention groups or control groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2024
CompletedFirst Posted
Study publicly available on registry
August 19, 2024
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
ExpectedAugust 19, 2024
August 1, 2024
1.7 years
August 15, 2024
August 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Change from baseline the Significant Other Scale for Hearing Disability, at 3 months, and 6 months.
A score of participants in baseline burden as assessed by the Significant Other Scale for Hearing Disability. The overall score ranging from 0 to 108, which higher scores indicating higher severe burden.
baseline, 3th, 6th month
Change from baseline the 10-item version of the Center for Epidemiological Studies Depression Scale at 3 months, and 6 months.
A score of participants in baseline depression as assessed by the 10-item version of the Center for Epidemiological Studies Depression Scale. The overall score ranging from 0 to 30, which higher scores indicating severe depression.
baseline, 3th, 6th month
Change from baseline the Brief Coping Orientation to Problems Experienced Scale at 3 months, and 6 months.
A score of participants in baseline coping as assessed by the Brief Coping Orientation to Problems Experienced Scale. The overall score ranging from 0 to 100, which higher scores indicating better coping.
baseline, 3th, 6th month
Change from baseline the Short Form Health Survey(SF-12) at 3 months, and 6 months.
A score of participants in baseline quality of life as assessed by the Short Form Health Survey(SF-12) . The overall score ranging from 0 to 100, which higher scores indicating better quality of life.
baseline, 3th, 6th month
Change from baseline the International Outcome Inventory for Hearing Aids-Significant Other at 3 months, and 6 months.
A score of participants in baseline overall intervention effectiveness and hearing aids satisfaction as assessed by the International Outcome Inventory for Hearing Aids-Significant Other. The overall score ranging from 7 to 35, which higher scores indicating better effectiveness of the intervention and aids satisfaction.
baseline, 3th, 6th month
Study Arms (2)
Group-based multi-component psycho-educational inventions (GMC-PEIs)
EXPERIMENTALGroup-based multi-component psycho-educational interventions. The participants were randomly assigned to either the experimental group or the waiting-list control group, using a computer-generated list of random numbers.
Controls group
NO INTERVENTIONWaitlist control group
Interventions
The participants were randomly assigned to either the experimental group, using a computer-generated list of random numbers.
Eligibility Criteria
You may qualify if:
- being18 or older
- living with older adults with hearing impairment
- they were indicated that as primary communication partner
- no known hearing loss
- having normal cognitive function
- articulate in the Mandarin Chinese language
- signing a consent form to participate
You may not qualify if:
- severe psychiatric disorders
- the communication partner who is hired as a caregiver
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, No. 1, Sec. 1, Jen-Ai Rd., 10051, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meei-Fang Lou
School of Nursing, College of Medicine, National Taiwan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2024
First Posted
August 19, 2024
Study Start
September 1, 2024
Primary Completion
April 30, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
August 19, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share