Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06559514

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Older Adults Behavior Behavioral Symptoms Communication Partners Depression Ear Diseases Hearing Disorders Hearing Impairment Hearing Loss Nervous System Diseases Neurologic Manifestations Nursing Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, No. 1, Sec. 1, Jen-Ai Rd., 10051, Taiwan

Location contact

Meei-Fang Lou, Ph.D.

CONTACT

[email protected]

886-2-23123456 ext. 288441

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Group-based multi-component psychoeducational inventions (GMC-PEIs)

Behavioral

The participants were randomly assigned to either the experimental group, using a computer-generated list of random numbers.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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 contacts

Contact information is provided by the study sponsor or research team.

Meei-Fang Lou, Ph.D

CONTACT

[email protected]

886-2-23123456 ext. 288441

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.