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Clinical Trials/NCT06559514
NCT06559514
Not yet recruiting
Not Applicable

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

National Taiwan University Hospital1 site in 1 country92 target enrollmentSeptember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Older Adults
Sponsor
National Taiwan University Hospital
Enrollment
92
Locations
1
Primary Endpoint
Change from baseline the 10-item version of the Center for Epidemiological Studies Depression Scale at 3 months, and 6 months.
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Detailed Description

The study will be an experimental design featuring repeated measures, with data collected from a pretest, a posttest and a follow-up test. An estimated total of 92 participants will be randomly assigned to experimental and control groups. The experimental group will participate in a 6-week group-based multi-component psycho-educational interventions (GMC-PEIs), including provide information on communication skills training, clear speech training, psychosocial support, stress management and successful person testimonial, consisting of 60-minute sessions once per week, while the control group will be put on a waiting-list group. Each group will be assessed of the outcomes at 3 time points: baseline (T0), three months following the intervention (T1) and again at six months following the intervention (T2). The investigators will use the Significant Other Scale for Hearing Disability (SOS-HEAR), the 10-item version of the Center for Epidemiological Studies Depression Scale (10-Item CES-D), the Brief Coping Orientation to Problems Experienced Scale (B-COPE), the Short Form Health Survey (SF-12) and the International Outcome Inventory for Hearing Aids-Significant Other (IOI-HA-SO) as the outcome indicators. The principle of intention-to-treat (ITT) analysis will be used, and the result will be analyzed mainly by generalized estimating equation (GEE).

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
July 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • severe psychiatric disorders
  • the communication partner who is hired as a caregiver

Outcomes

Primary Outcomes

Change from baseline the 10-item version of the Center for Epidemiological Studies Depression Scale at 3 months, and 6 months.

Time Frame: baseline, 3th, 6th month

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.

Change from baseline the Brief Coping Orientation to Problems Experienced Scale at 3 months, and 6 months.

Time Frame: baseline, 3th, 6th month

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.

Change from baseline the Short Form Health Survey(SF-12) at 3 months, and 6 months.

Time Frame: baseline, 3th, 6th month

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.

Change from baseline the Significant Other Scale for Hearing Disability, at 3 months, and 6 months.

Time Frame: baseline, 3th, 6th month

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.

Change from baseline the International Outcome Inventory for Hearing Aids-Significant Other at 3 months, and 6 months.

Time Frame: baseline, 3th, 6th month

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.

Study Sites (1)

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