NCT06105723

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

October 23, 2023

Last Update Submit

December 8, 2025

Conditions

Ageing Well

Keywords

AgingFunctional abilityCare modelCommunity-dwelling

Outcome Measures

Primary Outcomes (1)

  • 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.

    Changes from baseline to 3-month and 9-month post-intervention

Secondary Outcomes (11)

  • Hand grip strength

    Changes from baseline to 3-month and 9-month post-intervention

  • Balancing function

    Changes from baseline to 3-month and 9-month post-intervention

  • Physical mobility level

    Changes from baseline to 3-month and 9-month post-intervention

  • Sarcopenia risk

    Changes from baseline to 3-month and 9-month post-intervention

  • Nutritional status

    Changes from baseline to 3-month and 9-month post-intervention

  • +6 more secondary outcomes

Study Arms (2)

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.

Behavioral: Pathway to Healthy Aging care

Control

NO INTERVENTION

No care intervention will be provided.

Interventions

Pathway to Healthy Aging careBEHAVIORAL

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.

Path-HA care

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) aged 60 or above,
  • \) 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,
  • \) community-dwelling,
  • \) communicable to engage in health education activity.

You may not qualify if:

  • \) any who is not at or at only one risk factor of accelerating aging,
  • \) any who has problems in communicating with the research team.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Study Officials

  • Doris Sau Fung YU, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Doris Sau Fung YU, PhD

CONTACT

852 3817 6319dyu1@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor (Chair, Research)

Study Record Dates

First Submitted

October 23, 2023

First Posted

October 30, 2023

Study Start

January 1, 2024

Primary Completion

June 30, 2025

Study Completion

March 31, 2026

Last Updated

December 16, 2025

Record last verified: 2025-12

Locations

HK(1)