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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Ageing Well

Intervention / Treatment
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* Behavioral: Pathway to Healthy Aging care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) aged 60 or above, 2) 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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Path-HA care<br>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<br>* 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.<br>|
| No Intervention: Control<br>No care intervention will be provided. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand grip strength | Measured by hand-held dynamometer in unit of KG | Changes from baseline to 3-month and 6-month post-intervention | 
| Performance of timed up-and-go test | Measured by timed up-and-go test in unit of second | Changes from baseline to 3-month and 6-month post-intervention | 
| Mobility limitation score | Measured by Short Physical Performance Battery (scores range from 0 to 12), with higher score indicating better physical performance | Changes from baseline to 3-month and 6-month post-intervention | 
| Sarcopenia risk score | 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 | Changes from baseline to 3-month and 6-month post-intervention | 
| Geriatric depression score | Measured by The 8-item Geriatric Depression Scale (scores range from 0 to 8), with higher score indicating higher risk of depression | Changes from baseline to 3-month and 6-month post-intervention | 
| Cognitive functions score | 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 | Changes from baseline to 3-month and 6-month post-intervention | 
| Subjective memory score | Measured by Memory Inventory for the Chinese (scores range from 0 to 108), with higher score indicating more severe subjective memory loss | Changes from baseline to 3-month and 6-month post-intervention | 
| Loneliness score | Measured by UCLA Loneliness Scale questionnaire (scores range from 20 to 80), with higher score indicating greater loneliness | Changes from baseline to 3-month and 6-month post-intervention | 
| Insomnia risk score | Measured by Insomnia Severity Index questionnaire (scores range from 0 to 28), with higher score indicating greater severity of insomnia | Changes from baseline to 3-month and 6-month post-intervention | 
| Nutritional status score | Measured by Mini nutritional assessment (scores range from 0 to 30), with lower score indicating higher risk of malnutrition | Changes from baseline to 3-month and 6-month post-intervention | 
| Health status self-rated score | Measured by EQ05D-5L questionnaire (scores range from -0.59 to 1.0), with higher score indicating better quality of life | Changes from baseline to 3-month and 6-month post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aging, Functional ability, Care model, Community-dwelling