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

NCT ID: NCT06559514

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-07-31

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).

Conditions

Older Adults; Hearing Impairment; Nursing; Communication Partners

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Group-based multi-component psycho-educational inventions (GMC-PEIs)

Group-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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

Controls group

Waitlist control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meei-Fang Lou

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, College of Medicine, National Taiwan University

Locations

National Taiwan University Hospital

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

Countries

Taiwan

Central Contacts

Meei-Fang Lou, Ph.D

Role: CONTACT

mfalou@ntu.edu.tw

886-2-23123456 ext. 288441

Facility Contacts

Meei-Fang Lou, Ph.D.

Role: primary

mfalou@ntu.edu.tw

886-2-23123456 ext. 288441

Other Identifiers

202304022RINA

Identifier Type: -

Identifier Source: org_study_id