Clinical trial NCT06105723: An Effectiveness Evaluation for Pathway to Healthy Aging (Path-HA) Care on Health Status of Older Adults
Official title: An Effectiveness Evaluation for Pathway to Healthy Aging (Path-HA) Care on Health Status of Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ageing Well
Keywords: Aging
Functional ability
Care model
Community-dwelling
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Health-related quality of life
timeFrame: Changes from baseline to 3-month and 9-month post-intervention
Secondary outcomes:
measure: Hand grip strength
timeFrame: Changes from baseline to 3-month and 9-month post-intervention
measure: Balancing function
timeFrame: Changes from baseline to 3-month and 9-month post-intervention
measure: Physical mobility level
timeFrame: Changes from baseline to 3-month and 9-month post-intervention
measure: Sarcopenia risk
timeFrame: Changes from baseline to 3-month and 9-month post-intervention
measure: Nutritional status
timeFrame: Changes from baseline to 3-month and 9-month post-intervention
measure: Sleep quality
timeFrame: Changes from baseline to 3-month and 9-month post-intervention
measure: Depressed mood
timeFrame: Changes from baseline to 3-month and 9-month post-intervention
measure: Cognitive functions
timeFrame: Changes from baseline to 3-month and 9-month post-intervention
measure: Subjective memory
timeFrame: Changes from baseline to 3-month and 9-month post-intervention
measure: Loneliness
timeFrame: Changes from baseline to 3-month and 9-month post-intervention
measure: Social connectedness
timeFrame: Changes from baseline to 3-month and 9-month post-intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Doris Sau Fung YU, PhD
role: PRINCIPAL_INVESTIGATOR
References: