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Completed

NCT Number: NCT03528005

Effectiveness of Integrated Care Network

This project aims to examine the effectiveness of the community-based integrated care service model , based on a multi-domain intervention program, among community-dwelling older adults. Moreover, the investigators use the value-based healthcare standard set as well as comprehensive geriatric assessment as outcome measures and to use the randomized controlled trial design to validate the clinical effectiveness.

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Key information

Conditions

Fragility Multimorbidity

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation, Hualien City, Taiwan

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About this study

Population aging and the progress of medical technology are two main causes for the increase of healthcare expenditure. Effective management of medical expenditure and maintenance of health care quality have become the most important task for the public health and clinical care services. Both United Kingdom and the World Health Organization proposed introducing interdisciplinary team care to improve health of older people and to maximize their independence. Prof Michael Porter has addressed the current difficulty of healthcare system, and proposed that healthcare system should pursuit long-term outcome to promote the value of health care. This project aims to echo the international trends, using Taiwan healthcare system as the basis to establish the community-based integrated care service model, and to use the randomized controlled trial design to validate the clinical effectiveness.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age ≧ 65 years
  • three or more chronic conditions, defined by National Health Insurance list of chronic conditions
  • covered by National Health Insurance

Exclusion criteria

  • could not understanding protocol or communication with research nurses
  • malignant diseases under active treatments
  • life expectancy less than twelve months
  • admitted in the long term facility

Treatment and study plan

Multi-domain intervention

Behavioral

60 minutes cognitive training, 45 minutes physical exercise, 15 diet nutrition and intermittent disease management consultation

Primary outcomes

  1. Changes from baseline life quality at 3, 6, 9, 12 month

    Time frame: baseline, 3, 6, 9, 12 month

    measured by the 36-Item Short Form Health Survey (SF-36).

Secondary outcomes

  1. Changes from baseline standard set of health outcome measures for older persons at 3, 6, 9, 12 month

    Time frame: baseline, 3, 6, 9, 12 month

    a standard health care set proposed by the International Consortium for Health Outcomes Measurement (ICHOM)

Other outcomes

  1. Changes from baseline high sensitive C-Reactive Protein in mg/dl at sixth and twelfth month

    Time frame: baseline, 6,12 month

    Changes from baseline high sensitive C-Reactive Protein in mg/dl at sixth and twelfth month

  2. Changes from baseline total cholesterol in mg/dl at sixth and twelfth month

    Time frame: baseline, 6,12 month

    Changes from baseline total cholesterol in mg/dl at sixth and twelfth month

  3. Changes from baseline triglycerides in mg/dl at sixth and twelfth month

    Time frame: baseline, 6,12 month

    Changes from baseline triglycerides in mg/dl at sixth and twelfth month

  4. Changes from baseline HDL-C in mg/dl at sixth and twelfth month

    Time frame: baseline, 6,12 month

    Changes from baseline High-density lipoproteins (HDL) in mg/dl at sixth and twelfth month

  5. Changes from baseline LDL-C in mg/dl at sixth and twelfth month

    Time frame: baseline, 6,12 month

    Changes from baseline Low-density lipoproteins (LDL) in mg/dl at sixth and twelfth month

  6. Changes from baseline fasting glucose in mg/dl at sixth and twelfth month

    Time frame: baseline, 6,12 month

    Changes from baseline fasting glucose in mg/dl at sixth and twelfth month

  7. Changes from baseline HbA1c in % at sixth and twelfth month

    Time frame: baseline, 6,12 month

    Changes from baseline Hemoglobin A1c in % at sixth and twelfth month

  8. Changes from baseline insulin in mIU/L at sixth and twelfth month

    Time frame: baseline, 6,12 month

    Changes from baseline insulin in mIU/L at sixth and twelfth month

  9. Changes from baseline uric acid in mg/dl at sixth and twelfth month

    Time frame: baseline, 6,12 month

    Changes from baseline uric acid in mg/dl at sixth and twelfth month

  10. Changes from baseline body mass index in kg/m^2 at sixth and twelfth month

    Time frame: baseline, 6,12 month

    Changes from baseline body mass index in kg/m^2 at sixth and twelfth month

  11. Changes from baseline albumin in g/dl at sixth and twelfth month

    Time frame: baseline, 6,12 month

    Changes from baseline albumin in g/dl at sixth and twelfth month

  12. Changes from baseline Vitamin D in ng/ml at sixth and twelfth month

    Time frame: baseline, 6,12 month

    Changes from baseline Vitamin D in ng/ml at sixth and twelfth month

  13. Changes from baseline Vitamin B12 in pg/ml at sixth and twelfth month

    Time frame: baseline, 6,12 month

    Changes from baseline Vitamin B12 in pg/ml at sixth and twelfth month

  14. Changes from baseline homocysteine in micromol/l at sixth and twelfth month

    Time frame: baseline, 6,12 month

    Changes from baseline homocysteine in micromol/l at sixth and twelfth month

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

Effectiveness of Integrated Care Network for Community-living Older Adults: a Randomized-Controlled Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 17, 2018
Registry last updated
Apr 21, 2020

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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