Ageing WellNCT06105723
An Effectiveness Evaluation for Pathway to Healthy Aging (Path-HA) Care on Health Status of Older Adults
A study testing Pathway to Healthy Aging care in people with Ageing Well, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this clinical trial is to provide a scientific evaluation on the effects of a protocol-driven Pathway to Healthy Aging (Path-HA) Program on promoting the health-related quality of life and functional abilities of older adults who are at risk of accelerated aging in the community. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ageing Well
- What is being tested?
- Pathway to Healthy Aging care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) aged 60 or above,
- 2) with at least two risk factors of accelerating aging defined as including reduced physical functioning, malnutrition, depressed mood, loneliness, poor health perception, and presence of geriatric symptoms (e.g. insomnia, pain, etc), based on their health screening results,
- 3) community-dwelling,
- 4) communicable to engage in health education activity.
Who cannot join
- 1) any who is not at or at only one risk factor of accelerating aging,
- 2) any who has problems in communicating with the research team.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to provide a scientific evaluation on the effects of a protocol-driven Pathway to Healthy Aging (Path-HA) Program on promoting the health-related quality of life and functional abilities of older adults who are at risk of accelerated aging in the community. Participants will be randomized to one of the two study arms: 1) the intervention group to receive a 14-week Path-HA care intervention; and 2) the control group with no Path-HA care intervention.
Read the detailed description
This assessor-blind, randomized controlled trial evaluates the effects of the Pathway to Healthy Aging Program, which is based on the WHO ICOPE model, on the promotion of the health-related quality of life (primary outcome) as well as functional abilities (secondary outcomes) as defined by the WHO-ICOPE among community-dwelling older adults with accelerated aging. Six health domains including locomotor function, vitality, psychological function, cognitive function, social functions, and overall health-related quality of life are measured. A total of 1000 participants will be recruited. Outcome evaluation takes place at baseline, upon the completion of the care program, and at 6 months thereafter to allow the detection of long-term program benefits. In-depth individual interviews will be conducted to solicit the participants' experience and perceived benefits of the program.
- Conditions
- Ageing Well
- Being tested
- Pathway to Healthy Aging care
- Keywords
- Aging, Functional ability, Care model, Community-dwelling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathway to Healthy Aging careBehavioural
The ICOPE-based personalized care planning comprises two home visits. In 1st visit, a comprehensive assessment proposed by the WHO-ICOPE model is conducted to identify eight possible health problems including malnutrition, reduced physical fitness, fall risk, cognitive decline, insomnia, pain, psychological distress and social loneliness. After health problem identification, each participant receives a personalized care prescription. 2nd visit adopts a goal-oriented empowerment 3-step cycle to personalize the care planning: 1) communicating assessment results to increase healthy self-awareness; 2) supporting setting person-directed goals to address health problems; 3) identifying health actions and personalizing goal setting to participants' contexts. The 12-week healthy aging empowerment comprises three core activities for healthy aging promotion, including interactive health education, health message broadcasts, and three case conferences for goal monitoring and health counseling.
| Study group | Role | What they receive |
|---|---|---|
| Path-HA care | Experimental | A 14-week care initiative comprising two phases is provided, which are the 2-week ICOPE-based personalized care planning phase, and the 12-week healthy aging empowerment phase. Receives: Behavioral: Pathway to Healthy Aging care |
| Control | No intervention | No care intervention will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life
Measured by the EQ-5D-5L questionnaire (scores range from -0.59 to 1.0), with a higher score indicating better quality of life.
Measured: Changes from baseline to 3-month and 9-month post-intervention
Secondary outcomes (11)
Hand grip strength
Measured by hand-held dynamometer in unit of KG. A larger count indicates a greater grip strength.
Measured: Changes from baseline to 3-month and 9-month post-intervention
Balancing function
Measured by the Timed Up and Go Test in unit of second. A shorter completion time indicates better mobility and balance.
Measured: Changes from baseline to 3-month and 9-month post-intervention
Physical mobility level
Measured by the Short Physical Performance Battery (scores range from 0 to 12), with higher scores indicating better physical performance and better mobility functioning.
Measured: Changes from baseline to 3-month and 9-month post-intervention
Sarcopenia risk
Measured by Sarcopenia and calf circumference scale (SARC-CalF scale). The score ranges from 0 to 20 points, with a score ≥ 11 points suggestive of sarcopenia.
Measured: Changes from baseline to 3-month and 9-month post-intervention
Nutritional status
Measured by the Mini Nutritional Assessment (scores range from 0 to 30), with a lower score indicating a higher risk of malnutrition.
Measured: Changes from baseline to 3-month and 9-month post-intervention
Sleep quality
Measured by Insomnia Severity Index questionnaire (scores range from 0 to 28), with higher scores indicating greater severity of insomnia.
Measured: Changes from baseline to 3-month and 9-month post-intervention
Depressed mood
Measured by the 15-item Geriatric Depression Scale (scores range from 0 to 15), with a higher score indicating a higher risk of depression.
Measured: Changes from baseline to 3-month and 9-month post-intervention
Cognitive functions
Measured by the 5-minute Montreal Cognitive Assessment Test (scores range from 0 to 30). A raw score of < 25 in well-educated persons (education > 12 years) or a raw score of < 23 in less-educated persons (education ≤ 12 years) is defined as impaired cognition.
Measured: Changes from baseline to 3-month and 9-month post-intervention
Subjective memory
Measured by Memory Inventory for the Chinese (scores range from 0 to 108), with higher scores indicating more severe subjective memory loss.
Measured: Changes from baseline to 3-month and 9-month post-intervention
Loneliness
Measured by The 3-Item UCLA Loneliness Scale (scores range from 3 to 9), with higher scores suggesting a higher level of loneliness.
Measured: Changes from baseline to 3-month and 9-month post-intervention
Social connectedness
Measured by The 8-item version of Social Connectedness Scale (scores range from 8 to 48), with a higher score indicating a greater sense of social connectedness.
Measured: Changes from baseline to 3-month and 9-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Jan 2024
- Primary completion30 Jun 2025
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ageing WellStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Yu, Doris Sau Fung, The University of Hong Kong
- Investigators
- Doris Sau Fung YU, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105723
- Sponsor's protocol ID
- PATHHA
- Status last verified
- Jun 2026
- First submitted
- 23 Oct 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Effectiveness Evaluation for Pathway to Healthy Aging (Path-HA) Care on Health Status of Older Adults
- ClinicalTrials.gov ID
- NCT06105723
- Acronym / sponsor ID
- PATHHA
- Conditions
- Ageing Well
- Keywords
- Aging, Functional ability, Care model, Community-dwelling
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 30 Oct 2023 (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.
The goal of this clinical trial is to provide a scientific evaluation on the effects of a protocol-driven Pathway to Healthy Aging (Path-HA) Program on promoting the health-related quality of life and functional abilities of older adults who are at risk of accelerated aging in the community. Participants will be randomized to one of the two study arms: 1) the intervention group to receive a 14-week Path-HA care intervention; and 2) the control group with no Path-HA care intervention.
Detailed description
This assessor-blind, randomized controlled trial evaluates the effects of the Pathway to Healthy Aging Program, which is based on the WHO ICOPE model, on the promotion of the health-related quality of life (primary outcome) as well as functional abilities (secondary outcomes) as defined by the WHO-ICOPE among community-dwelling older adults with accelerated aging. Six health domains including locomotor function, vitality, psychological function, cognitive function, social functions, and overall health-related quality of life are measured. A total of 1000 participants will be recruited. Outcome evaluation takes place at baseline, upon the completion of the care program, and at 6 months thereafter to allow the detection of long-term program benefits. In-depth individual interviews will be conducted to solicit the participants' experience and perceived benefits of the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Path-HA care | Experimental | Behavioral: Pathway to Healthy Aging careA 14-week care initiative comprising two phases is provided, which are the 2-week ICOPE-based personalized care planning phase, and the 12-week healthy aging empowerment phase. |
| Control | No intervention | –No care intervention will be provided. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1) aged 60 or above,
- 2) with at least two risk factors of accelerating aging defined as including reduced physical functioning, malnutrition, depressed mood, loneliness, poor health perception, and presence of geriatric symptoms (e.g. insomnia, pain, etc), based on their health screening results,
- 3) community-dwelling,
- 4) communicable to engage in health education activity.
Key exclusion criteria (2 listed)
- 1) any who is not at or at only one risk factor of accelerating aging,
- 2) any who has problems in communicating with the research team.
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 |
|---|---|---|
| Pathway to Healthy Aging careThe ICOPE-based personalized care planning comprises two home visits. In 1st visit, a comprehensive assessment proposed by the WHO-ICOPE model is conducted to identify eight possible health problems including malnutrition, reduced physical fitness, fall risk, cognitive decline, insomnia, pain, psychological distress and social loneliness. After health problem identification, each participant receives a personalized care prescription. 2nd visit adopts a goal-oriented empowerment 3-step cycle to personalize the care planning: 1) communicating assessment results to increase healthy self-awareness; 2) supporting setting person-directed goals to address health problems; 3) identifying health actions and personalizing goal setting to participants' contexts. The 12-week healthy aging empowerment comprises three core activities for healthy aging promotion, including interactive health education, health message broadcasts, and three case conferences for goal monitoring and health counseling. | Behavioural | Path-HA care |
Primary outcome
Health-related quality of life
Time frame: Changes from baseline to 3-month and 9-month post-intervention
Measured by the EQ-5D-5L questionnaire (scores range from -0.59 to 1.0), with a higher score indicating better quality of life.
11 secondary outcomes
Hand grip strength
Time frame: Changes from baseline to 3-month and 9-month post-intervention
Balancing function
Time frame: Changes from baseline to 3-month and 9-month post-intervention
Physical mobility level
Time frame: Changes from baseline to 3-month and 9-month post-intervention
Sarcopenia risk
Time frame: Changes from baseline to 3-month and 9-month post-intervention
Nutritional status
Time frame: Changes from baseline to 3-month and 9-month post-intervention
Sleep quality
Time frame: Changes from baseline to 3-month and 9-month post-intervention
Depressed mood
Time frame: Changes from baseline to 3-month and 9-month post-intervention
Cognitive functions
Time frame: Changes from baseline to 3-month and 9-month post-intervention
Subjective memory
Time frame: Changes from baseline to 3-month and 9-month post-intervention
Loneliness
Time frame: Changes from baseline to 3-month and 9-month post-intervention
Social connectedness
Time frame: Changes from baseline to 3-month and 9-month post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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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.
Doris Sau Fung YU, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pathway to Healthy Aging care in people with Ageing Well, run by The University of Hong Kong 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 4 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: under way, not looking for participants, as of the sponsor's last update on 16 Jun 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?
This study is still under way. Results are not available in the source record yet.
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?
Health-related quality of life (time frame: Changes from baseline to 3-month and 9-month post-intervention). 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 16 Jun 2026.