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Not yet recruiting NCT06559514

Effect of Psycho-Educational Interventions in Communication Partners of Older Adults With Hearing Impairment

No phase Interventional Older Adults Hearing Impairment Nursing Communication Partners

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Group-based multi-component psychoeducational inventions (GMC-PEIs).
Who it may be relevant to
Registry conditions: Older Adults, Hearing Impairment, Nursing, Communication Partners. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Interventions

  • Behavioral Group-based multi-component psychoeducational inventions (GMC-PEIs)
    The participants were randomly assigned to either the experimental group, using a computer-generated list of random numbers.

Primary outcome measures

  • Change from baseline the Significant Other Scale for Hearing Disability, at 3 months, and 6 months. [Time frame: 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. [Time frame: baseline, 3th, 6th month]
  • Change from baseline the Brief Coping Orientation to Problems Experienced Scale at 3 months, and 6 months. [Time frame: baseline, 3th, 6th month]
  • Change from baseline the Short Form Health Survey(SF-12) at 3 months, and 6 months. [Time frame: baseline, 3th, 6th month]
  • Change from baseline the International Outcome Inventory for Hearing Aids-Significant Other at 3 months, and 6 months. [Time frame: baseline, 3th, 6th month]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei

Identifiers

NCT: NCT06559514 · 202304022RINA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗