FrailtyNCT06415604
Home-based Psychoeducation for Older Adults With Frailty
A study testing Psychoeducation in people with Frailty and Well-Being, Psychological, run by TAO An at 1 site in Hong Kong.
Trial summary
This study aims to examine the effectiveness of a 12-week home-based telerehabilitation programme on improving subjective well-being among community-dwelling older people with frailty. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Well-Being, Psychological
- What is being tested?
- Psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Jun 2024to 20 Jun 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 years or over
- Meeting frailty criteria by FRAIL scale (score 3 or above)
- Mentally competent screened by The Abbreviated Mental Test (AMT ≥ 6)
- Able to speak and understand Cantonese
- Living at home
- Having experience using a smartphone (e.g., sending messages, watching videos)
Who cannot join
- A visual or hearing problem or a language barrier that may affect their communication or understanding
- A life expectancy of less than 6 months
- Engaged in 150 minutes or more of exercise per week
- Undergoing psychiatric treatment or taking antidepressant medication, or participating in other studies
- Have undergone major surgery in the past six months or are scheduled for major surgery in the next six months
- Any of the following conditions against physical exercises:
Show all 18Show fewer
- Acute myocardial infarction or recent unstable angina
- Uncontrolled atrial/ventricular arrhythmias
- Dissecting aortic aneurysm
- Severe aortic stenosis
- Endocarditis/acute pericarditis
- Uncontrolled hypertension
- Acute thromboembolic events
- Acute or severe heart failure
- Acute or severe respiratory failure
- Uncontrolled orthostatic hypotension
- Acute decompensated diabetes or uncontrolled hypoglycemia
- A fracture in the past month
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Nethersole School of Nursing, The Chinese University of Hong Kong
Shatin, New Territories
About this study
Official title: Effects of a Home-based Psychoeducation on Subjective Well-being for Older Adults With Frailty in the Community: A Randomised Controlled Trial
This study aims to examine the effectiveness of a 12-week home-based telerehabilitation programme on improving subjective well-being among community-dwelling older people with frailty.
The main question it aims to answer is
Read more
- Could home-based psychoeducation significantly enhance subjective well-being in older adults with frailty in the community?
Participants will receive 12 weekly online group-based sessions at their homes. The content for the experimental group and control group is different:
- Intervention group: psychoeducation
- Control group: physical health education Participants will receive three home visits for data collection. Some of participants in experimental group will receive interview for process evaluation.
- Conditions
- Frailty, Well-Being, Psychological
- Being tested
- Psychoeducation, Attention control
- Keywords
- Subjective well-being, frailty, psychoeducation
- Medical subject headings
- Frailty, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationOther
The content of psychoeducation is based on "Five Ways of Well-being" which covers "Be active", "Connect", "Take Notice", "Keep learning" and "Giving".
Attention controlOther
The content of the sessions mainly focuses on physical health information, such as healthy eating, physical exercise, prevention of falls, and pain management.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants will receive 60-minute weekly online group-based psychoeducation sessions for 12 weeks. Receives: Other: Psychoeducation |
| Control group | Active comparator | Participants will receive 60-minute weekly online group-based physical health sessions for 12 weeks. Receives: Other: Attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective well-being
The Chinese 5-item World Health Organization Well-Being Index: scores range from 0 to 25. Higher scores indicate greater levels of subjective well-being
Measured: baseline, 12 weeks post-allocation, 24 weeks post-allocation
Secondary outcomes (6)
Physical functioning
The Senior Fitness Test: It include seven test: the 30-sec arm-curl test, 30-sec chair-stand test, back-scratch test, chair sit-and-reach test, 8-foot up-and-go test, two-min step test, BMI
Measured: baseline, 12 weeks post-allocation, 24 weeks post-allocation
Activities of daily living
Katz Index of Independence in Activities of Daily Living: scores range from 0 to 12. Higher scores indicate greater independence
Measured: baseline, 12 weeks post-allocation, 24 weeks post-allocation
Instrumental activities of daily living
Lawton Instrumental Activities of Daily Living Scale: scores range from 0 to 8. Higher scores indicate greater independence
Measured: baseline, 12 weeks post-allocation, 24 weeks post-allocation
Depressive symptoms
4-item Geriatric Depression scale: scores range from 0 to 4. Higher scores indicate higher level of depressive symptoms
Measured: baseline, 12 weeks post-allocation, 24 weeks post-allocation
Social support
10-item Duke Social Support Index: scores range from 10 to 30. Higher scores on the DSSI-10 indicate better perceived social support
Measured: baseline, 12 weeks post-allocation, 24 weeks post-allocation
Health-related Quality of life
EuroQol 5-Dimension 5-Level: scores range from -0.865 to 1. Higher scores indicate better health-related quality of life
Measured: baseline, 12 weeks post-allocation, 24 weeks post-allocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start10 Jun 2024
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- TAO An
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, TAO An, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415604
- Sponsor's protocol ID
- 2023.585.M
- Status last verified
- Nov 2026
- First submitted
- 10 May 2024
- Last updated
- 4 Nov 2026
- Results posted
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Home-based Psychoeducation on Subjective Well-being for Older Adults With Frailty in the Community: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06415604
- Acronym / sponsor ID
- 2023.585.M
- Conditions
- Frailty, Well-Being, Psychological
- Keywords
- Subjective well-being, frailty, psychoeducation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- TAO AnUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 16 May 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.
This study aims to examine the effectiveness of a 12-week home-based telerehabilitation programme on improving subjective well-being among community-dwelling older people with frailty.
The main question it aims to answer is
- Could home-based psychoeducation significantly enhance subjective well-being in older adults with frailty in the community?
Participants will receive 12 weekly online group-based sessions at their homes. The content for the experimental group and control group is different:
- Intervention group: psychoeducation
- Control group: physical health education Participants will receive three home visits for data collection. Some of participants in experimental group will receive interview for process evaluation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: PsychoeducationParticipants will receive 60-minute weekly online group-based psychoeducation sessions for 12 weeks. |
| Control group | Active comparator | Other: Attention controlParticipants will receive 60-minute weekly online group-based physical health sessions for 12 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Aged 65 years or over
- Meeting frailty criteria by FRAIL scale (score 3 or above)
- Mentally competent screened by The Abbreviated Mental Test (AMT ≥ 6)
- Able to speak and understand Cantonese
- Living at home
Key exclusion criteria (18 listed)
- A visual or hearing problem or a language barrier that may affect their communication or understanding
- A life expectancy of less than 6 months
- Engaged in 150 minutes or more of exercise per week
- Undergoing psychiatric treatment or taking antidepressant medication, or participating in other studies
- Have undergone major surgery in the past six months or are scheduled for major surgery in the next six months
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 |
|---|---|---|
| PsychoeducationThe content of psychoeducation is based on "Five Ways of Well-being" which covers "Be active", "Connect", "Take Notice", "Keep learning" and "Giving". | Other | Experimental group |
| Attention controlThe content of the sessions mainly focuses on physical health information, such as healthy eating, physical exercise, prevention of falls, and pain management. | Other | Control group |
Primary outcome
Subjective well-being
Time frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation
The Chinese 5-item World Health Organization Well-Being Index: scores range from 0 to 25. Higher scores indicate greater levels of subjective well-being
6 secondary outcomes
Physical functioning
Time frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation
Activities of daily living
Time frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation
Instrumental activities of daily living
Time frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation
Depressive symptoms
Time frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation
Social support
Time frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation
Health-related Quality of life
Time frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation in people with Frailty and Well-Being, Psychological, run by TAO An at 1 site in Hong Kong.
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 6 inclusion and 18 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: finished, as of the sponsor's last update on 4 Nov 2026. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective well-being (time frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation). 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 4 Nov 2026.