Older AdultsNCT06559514
Effect of Psycho-Educational Interventions in Communication Partners of Older Adults With Hearing Impairment
A study testing Group-based multi-component psychoeducational inventions (GMC-PEIs) in people with Older Adults and Hearing Impairment, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Older Adults, Hearing Impairment, Nursing
- What is being tested?
- Group-based multi-component psychoeducational inventions (GMC-PEIs)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2024to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- severe psychiatric disorders
- the communication partner who is hired as a caregiver
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, No. 1, Sec. 1, Jen-Ai Rd., 10051
Meei-Fang Lou, Ph.D., 886-2-23123456 ext. 288441, mfalou@ntu.edu.tw
About this study
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
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.
Read the 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
- Being tested
- Group-based multi-component psychoeducational inventions (GMC-PEIs)
- Keywords
- group-based multi-component interventions, psychoeducation, hearing impairment, older adults, communication partners, burden, depression, coping, quality of life
- Medical subject headings
- Hearing Loss, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based multi-component psychoeducational inventions (GMC-PEIs)Behavioural
The participants were randomly assigned to either the experimental group, using a computer-generated list of random numbers.
| Study group | Role | What they receive |
|---|---|---|
| Group-based multi-component psycho-educational inventions (GMC-PEIs) | Experimental | 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. Receives: Behavioral: Group-based multi-component psychoeducational inventions (GMC-PEIs) |
| Controls group | No intervention | Waitlist control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline the Significant Other Scale for Hearing Disability, at 3 months, and 6 months.
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.
Measured: 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.
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.
Measured: baseline, 3th, 6th month
Change from baseline the Brief Coping Orientation to Problems Experienced Scale at 3 months, and 6 months.
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.
Measured: baseline, 3th, 6th month
Change from baseline the Short Form Health Survey(SF-12) at 3 months, and 6 months.
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.
Measured: baseline, 3th, 6th month
Change from baseline the International Outcome Inventory for Hearing Aids-Significant Other at 3 months, and 6 months.
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.
Measured: baseline, 3th, 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meei-Fang Lou, Principal investigator, School of Nursing, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559514
- Sponsor's protocol ID
- 202304022RINA
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06559514
- Acronym / sponsor ID
- 202304022RINA
- Conditions
- Older Adults, Hearing Impairment, Nursing, Communication Partners
- Keywords
- group-based multi-component interventions, psychoeducation, hearing impairment, older adults, communication partners, burden, depression, coping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Group-based multi-component psycho-educational inventions (GMC-PEIs) | Experimental | Behavioral: Group-based multi-component psychoeducational 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. |
| Controls group | No intervention | –Waitlist control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- severe psychiatric disorders
- the communication partner who is hired as a caregiver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Group-based multi-component psycho-educational inventions (GMC-PEIs) |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meei-Fang Lou principal investigator
School of Nursing, College of Medicine, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based multi-component psychoeducational inventions (GMC-PEIs) in people with Older Adults and Hearing Impairment, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meei-Fang Lou, Ph.D (886-2-23123456 ext. 288441, mfalou@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline the Significant Other Scale for Hearing Disability, at 3 months, and 6 months. (time frame: baseline, 3th, 6th month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.