An Effectiveness Evaluation for Pathway to Healthy Aging (Path-HA) Care on Health Status of Older Adults

Sponsor
The University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT06105723
Collaborator
(none)
1,000
1
2
35.5
28.2

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to provide a scientific evaluation on the effects of a protocol-driven critical pathway, Pathway to Healthy Aging (Path-HA), on promoting functional ability as defined by the WHO ICOPE 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 3-month Path-HA care intervention; and 2) the control group with no Path-HA care intervention.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Pathway to Healthy Aging care
N/A

Detailed Description

This clinical trial uses a single-blind randomized controlled design to evaluate the effects of the 3-month care intervention guided by the critical pathway developed by the Pathway to Healthy Aging program on the health status of older adults at risk of accelerated aging. Six health domains including functional status, mental wellness, cognitive function, social loneliness, geriatric symptoms and overall quality of life are measured. A total of 1000 participants will be recruited. Outcome evaluation 3 months after intervention and 6 months after intervention will be included 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

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
An Effectiveness Evaluation for Pathway to Healthy Aging (Path-HA) Care on Health Status of Older Adults
Actual Study Start Date :
Jul 15, 2022
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Path-HA care

A 3-month care initiative comprising two phases is provided, which are the care mapping phase and the empowerment cycle phase.

Behavioral: Pathway to Healthy Aging care
In the care mapping phase, participants receive a care mapping guided by the critical pathway using the WHO ICOPE assessment, and receive a personalized Healthy Aging Pass (HA Pass) which documents a series of goal-directed actions required to reduce the health risks of accelerating aging. In the empowerment cycle phase, participants are empowered to attain goals, which includes a series of activities, including 1) communicating assessment results with participants to increase their healthy self-awareness; 2) motivating participants' goal setting to integrate health behaviors into daily life; 3) personalizing goal setting to participants' preferences and contexts; 4) supporting participants to implement their action plans in a partnership relationship; 5) monitoring the level of goal attainment of participants and to support them to resolve the barriers.

No Intervention: Control

No care intervention will be provided.

Outcome Measures

Primary Outcome Measures

  1. Hand grip strength [Changes from baseline to 3-month and 6-month post-intervention]

    Measured by hand-held dynamometer in unit of KG

  2. Performance of timed up-and-go test [Changes from baseline to 3-month and 6-month post-intervention]

    Measured by timed up-and-go test in unit of second

  3. Mobility limitation score [Changes from baseline to 3-month and 6-month post-intervention]

    Measured by Short Physical Performance Battery (scores range from 0 to 12), with higher score indicating better physical performance

  4. Sarcopenia risk score [Changes from baseline to 3-month and 6-month post-intervention]

    Measured by Sarcopenia and calf circumference scale in unit of cm (scores range from 0 to 20), with higher score indicating higher risk of sarcopenia

  5. Geriatric depression score [Changes from baseline to 3-month and 6-month post-intervention]

    Measured by The 8-item Geriatric Depression Scale (scores range from 0 to 8), with higher score indicating higher risk of depression

  6. Cognitive functions score [Changes from baseline to 3-month and 6-month post-intervention]

    Measured by Montreal Cognitive Assessment (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

  7. Subjective memory score [Changes from baseline to 3-month and 6-month post-intervention]

    Measured by Memory Inventory for the Chinese (scores range from 0 to 108), with higher score indicating more severe subjective memory loss

  8. Loneliness score [Changes from baseline to 3-month and 6-month post-intervention]

    Measured by UCLA Loneliness Scale questionnaire (scores range from 20 to 80), with higher score indicating greater loneliness

  9. Insomnia risk score [Changes from baseline to 3-month and 6-month post-intervention]

    Measured by Insomnia Severity Index questionnaire (scores range from 0 to 28), with higher score indicating greater severity of insomnia

  10. Nutritional status score [Changes from baseline to 3-month and 6-month post-intervention]

    Measured by Mini nutritional assessment (scores range from 0 to 30), with lower score indicating higher risk of malnutrition

  11. Health status self-rated score [Changes from baseline to 3-month and 6-month post-intervention]

    Measured by EQ05D-5L questionnaire (scores range from -0.59 to 1.0), with higher score indicating better quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
    1. aged 60 or above,
    1. with at least two risk factors of accelerating aging based on their health screening results.
Exclusion Criteria:
  • Any who is not at or at only one risk factor of accelerating aging.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Hong Kong Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

  • Principal Investigator: Doris Sau Fung YU, PhD, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT06105723
Other Study ID Numbers:
  • PATHHA
First Posted:
Oct 30, 2023
Last Update Posted:
Nov 1, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The University of Hong Kong

Study Results

No Results Posted as of Nov 1, 2023