Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559514
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Effect of Psycho-Educational Interventions in Communication Partners of Older Adults With Hearing Impairment
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None