Clinical trial NCT06559514: Effect of Psycho-Educational Interventions in Communication Partners of Older Adults With Hearing Impairment
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Older Adults
Hearing Impairment
Nursing
Communication Partners
Keywords: group-based multi-component interventions
psychoeducation
hearing impairment
older adults
communication partners
burden
depression
coping
quality of life
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this single-blind, randomized controlled trial, adults aged years or older living with hearing impairment elderly will be randomized into either the intervention group (group-based multi-component psychoeducational inventions, GMC-PEIs intervention group) or the control group (waitlist control group).
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: Change from baseline the Significant Other Scale for Hearing Disability, at 3 months, and 6 months.
timeFrame: baseline, 3th, 6th month
measure: Change from baseline the 10-item version of the Center for Epidemiological Studies Depression Scale at 3 months, and 6 months.
timeFrame: baseline, 3th, 6th month
measure: Change from baseline the Brief Coping Orientation to Problems Experienced Scale at 3 months, and 6 months.
timeFrame: baseline, 3th, 6th month
measure: Change from baseline the Short Form Health Survey(SF-12) at 3 months, and 6 months.
timeFrame: baseline, 3th, 6th month
measure: Change from baseline the International Outcome Inventory for Hearing Aids-Significant Other at 3 months, and 6 months.
timeFrame: baseline, 3th, 6th month
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: No. 1, Sec. 1, Jen-Ai Rd.
Study officials:
affiliation: School of Nursing, College of Medicine, National Taiwan University
name: Meei-Fang Lou
role: PRINCIPAL_INVESTIGATOR
References: