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

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.

Study Overview

• Status: Recruiting
• Conditions: Ageing Well
• Intervention / Treatment: Behavioral: Pathway to Healthy Aging care

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 Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Doris Sau Fung YU, PhD; Phone Number: 852 3817 6319; Email: dyu1@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The University of Hong Kong
    • Contact: Doris Sau Fung Yu, PhD; Phone Number: 3817 6319; Email: dyu1@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No care intervention will be provided.
Experimental: Path-HA care; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand grip strength	Measured by hand-held dynamometer in unit of KG. A larger count indicates a greater grip strength.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Changes from baseline to 3-month and 9-month post-intervention

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Aging; Functional ability; Care model; Community-dwelling
• Other Study ID Numbers: PATHHA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No