FrailtyNCT06415617
Home-based Psychoeducation for Older Adults With Frailty: A Feasibility Trial
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 test the feasibility and acceptability of home-based psychoeducation in older adults with frailty in the community. The main questions it aims to answer are 1. Are the proposed eligibility criteria for participants and the study process in recruiting and retaining the participants appropriate? 2. 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
- 24 participants
- Where
- 1 siteHong Kong
- Study dates
- 24 Nov 2023to 9 Apr 2024
- 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; (2) meeting frailty criteria by FRAIL scale (score 3 or above) ; (3) mentally competent screened by The Abbreviated Mental Test (AMT≥6) ; (4) able to speak and understand Cantonese; (5) living at home; (6) having experience using a smartphone (e.g.: sending messages, watching videos)
Who cannot join
- have a visual or hearing problem or a language barrier that may affect their communication or understanding; (2) being unfit for home-based exercise, as defined by having one point or above at either the 25-item Home Falls and Accidents self-reported screening tool (HOME-FAST), which is a comprehensive tool for identify home hazards for fall (3) are currently practising exercise for at least 150 minutes per week in previous four weeks; (4) are receiving active psychiatric or antidepressant treatment or joining other physical exercises or rehabilitation programmes
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 Programme on Subjective Well-being for Older Adults With Frailty in the Community: A Feasibility Trial
This study aims to test the feasibility and acceptability of home-based psychoeducation in older adults with frailty in the community. The main questions it aims to answer are
- Are the proposed eligibility criteria for participants and the study process in recruiting and retaining the participants appropriate?
- Is home-based psychoeducation feasible and acceptable for older adults with frailty in the community?
Read more
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 two home visits for data collection. An individual interview will be conducted with participants in the experimental group to explore their experiences.
- 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" . The participants will be engaged in psychoeducation through group discussion, individualised goal setting and reflective exercises.
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.
Participation rate, self-reported intervention adherence, and attrition rate.
The feasibility of the study will be measured in terms of participation rate, self-reported intervention adherence, and attrition rate.
Measured: 12 weeks post-allocation
Acceptability
A 5-item satisfaction survey will be conducted by the end of the intervention for participants to rate the intervention in terms of appropriates of the session content, length of each session, overall intervention duration and delivery mode, from 1 (very dissatisfied) to 5 (very satisfied).
Measured: 12 weeks post-allocation
Secondary outcomes (8)
Frailty level
FRAIL scale
Measured: 12 weeks post-allocation
Physical functioning
The Senior Fitness Test: It covers four dimensions, including muscle endurance, balance, flexibility, and tolerance measured by 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.
Measured: 12 weeks post-allocation
Activities of daily living
Katz Index of Independence in Activities of Daily Living
Measured: 12 weeks post-allocation
Instrumental activities of daily living
Lawton Instrumental Activities of Daily Living Scale
Measured: 12 weeks post-allocation
Subjective well-being
The Chinese 5-item World Health Organization Well-Being Index
Measured: 12 weeks post-allocation
Depressive symptoms
4-item Geriatric Depression scale
Measured: 12 weeks post-allocation
Social support
10-item Duke Social Support Index
Measured: 12 weeks post-allocation
Quality of life
EuroQol 5-Dimension 5-Level
Measured: 12 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 start24 Nov 2023
- Primary completion9 Apr 2024
- Study completion9 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 24 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
- NCT06415617
- Sponsor's protocol ID
- 2023.585.p
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tao A, Chan HYL, Xiao S, Ho KHM. A Home-Based Online Psychoeducation Programme on Subjective Well-Being Amongst Community-Dwelling Older Adults With Frailty: A Pilot Randomised Controlled Trial. Int J Older People Nurs. 2026 May;21(3):e70079. doi: 10.1111/opn.70079.
PubMed 41992403
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of A Home-based Psychoeducation Programme on Subjective Well-being for Older Adults With Frailty in the Community: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT06415617
- Acronym / sponsor ID
- 2023.585.p
- Conditions
- Frailty, Well-Being, Psychological
- Keywords
- Subjective well-being, frailty, psychoeducation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- TAO AnUniversity, hospital or other
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 9 Apr 2024 (actual)
- Study completion
- 9 Apr 2024 (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 test the feasibility and acceptability of home-based psychoeducation in older adults with frailty in the community. The main questions it aims to answer are
- Are the proposed eligibility criteria for participants and the study process in recruiting and retaining the participants appropriate?
- Is home-based psychoeducation feasible and acceptable for 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 two home visits for data collection. An individual interview will be conducted with participants in the experimental group to explore their experiences.
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 (1 listed)
- aged 65 years or over; (2) meeting frailty criteria by FRAIL scale (score 3 or above) ; (3) mentally competent screened by The Abbreviated Mental Test (AMT≥6) ; (4) able to speak and understand Cantonese; (5) living at home; (6) having experience using a smartphone (e.g.: sending messages, watching videos)
Key exclusion criteria (1 listed)
- have a visual or hearing problem or a language barrier that may affect their communication or understanding; (2) being unfit for home-based exercise, as defined by having one point or above at either the 25-item Home Falls and Accidents self-reported screening tool (HOME-FAST), which is a comprehensive tool for identify home hazards for fall (3) are currently practising exercise for at least 150 minutes per week in previous four weeks; (4) are receiving active psychiatric or antidepressant treatment or joining other physical exercises or rehabilitation programmes
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" . The participants will be engaged in psychoeducation through group discussion, individualised goal setting and reflective exercises. | 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
Participation rate, self-reported intervention adherence, and attrition rate.
Time frame: 12 weeks post-allocation
The feasibility of the study will be measured in terms of participation rate, self-reported intervention adherence, and attrition rate.
Acceptability
Time frame: 12 weeks post-allocation
A 5-item satisfaction survey will be conducted by the end of the intervention for participants to rate the intervention in terms of appropriates of the session content, length of each session, overall intervention duration and delivery mode, from 1 (very dissatisfied) to 5 (very satisfied).
8 secondary outcomes
Frailty level
Time frame: 12 weeks post-allocation
Physical functioning
Time frame: 12 weeks post-allocation
Activities of daily living
Time frame: 12 weeks post-allocation
Instrumental activities of daily living
Time frame: 12 weeks post-allocation
Subjective well-being
Time frame: 12 weeks post-allocation
Depressive symptoms
Time frame: 12 weeks post-allocation
Social support
Time frame: 12 weeks post-allocation
Quality of life
Time frame: 12 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 16 May 2024.
- Derived from this study: PubMed 41992403Tao A, Chan HYL, Xiao S, Ho KHM. A Home-Based Online Psychoeducation Programme on Subjective Well-Being Amongst Community-Dwelling Older Adults With Frailty: A Pilot Randomised Controlled Trial. Int J Older People Nurs. 2026 May;21(3):e70079. doi: 10.1111/opn.70079.
- Individual participant dataSharing planned: No
Related trials for Frailty
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
Mobility Impairment, Frailty
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
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 1 inclusion and 1 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 16 May 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 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?
Participation rate, self-reported intervention adherence, and attrition rate. (time frame: 12 weeks post-allocation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06415617, which also lists 1 linked publication.
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 16 May 2024.