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Active, Not Recruiting

NCT Number: NCT06105723

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ageing Well

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pathway to Healthy Aging care

Behavioral

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.

Primary outcomes

  1. Health-related quality of life

    Time frame: Changes from baseline to 3-month and 9-month post-intervention

    Measured by the EQ-5D-5L questionnaire (scores range from -0.59 to 1.0), with a higher score indicating better quality of life.

Secondary outcomes

  1. Hand grip strength

    Time frame: Changes from baseline to 3-month and 9-month post-intervention

    Measured by hand-held dynamometer in unit of KG. A larger count indicates a greater grip strength.

  2. Balancing function

    Time frame: Changes from baseline to 3-month and 9-month post-intervention

    Measured by the Timed Up and Go Test in unit of second. A shorter completion time indicates better mobility and balance.

  3. Physical mobility level

    Time frame: Changes from baseline to 3-month and 9-month post-intervention

    Measured by the Short Physical Performance Battery (scores range from 0 to 12), with higher scores indicating better physical performance and better mobility functioning.

  4. Sarcopenia risk

    Time frame: Changes from baseline to 3-month and 9-month post-intervention

    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.

  5. Nutritional status

    Time frame: Changes from baseline to 3-month and 9-month post-intervention

    Measured by the Mini Nutritional Assessment (scores range from 0 to 30), with a lower score indicating a higher risk of malnutrition.

  6. Sleep quality

    Time frame: Changes from baseline to 3-month and 9-month post-intervention

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

  7. Depressed mood

    Time frame: Changes from baseline to 3-month and 9-month post-intervention

    Measured by the 15-item Geriatric Depression Scale (scores range from 0 to 15), with a higher score indicating a higher risk of depression.

  8. Cognitive functions

    Time frame: Changes from baseline to 3-month and 9-month post-intervention

    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.

  9. Subjective memory

    Time frame: Changes from baseline to 3-month and 9-month post-intervention

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

  10. Loneliness

    Time frame: Changes from baseline to 3-month and 9-month post-intervention

    Measured by The 3-Item UCLA Loneliness Scale (scores range from 3 to 9), with higher scores suggesting a higher level of loneliness.

  11. Social connectedness

    Time frame: Changes from baseline to 3-month and 9-month post-intervention

    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.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 30, 2023
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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