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High-need Community Older Adults Care Delivery Model (HCOACDM)

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ClinicalTrials.gov Identifier: NCT03864471
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : March 11, 2019
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
Kuei-Min Chen, Ph.D., RN., Kaohsiung Medical University

Brief Summary:
This study is proposed to: (1) establish a "High-need Community Older Adults Care Delivery Model" (HCOACDM) as a guide to handle complex needs of the high-need community older adults by the care managers at community care centers; and (2) evaluate the effectiveness of applying the HCOACDM to improve the functional ability, quality of life (QOL), depressive symptoms, healthcare and social service utilizations, and care delivery satisfaction of the high-need community older adults.

Condition or disease Intervention/treatment Phase
High-need Older Adults Other: HCOACDM Other: Routine care Not Applicable

Detailed Description:
A cluster randomized controlled trial with repeated measures design will be conducted to test the effectiveness of six-month HCOACDM on the functional ability, QOL, depressive symptoms, healthcare and social service utilizations, and care delivery satisfaction of the high-need community older adults. The high-need community older adults, screened based on the "High-need Community Older Adults Screening Scale" (HCOASS), will be cluster randomized based on the community care centers, to the intervention group (4 centers) or comparison group (4 centers). Intervention group will receive six-month HCOACDM care and comparison group will receive original routine care provided by the care managers at community care centers. One pre-test and two post-tests, three months apart, of outcome measurements will be conducted on all participants. Moreover, individual semi-structured interviews will be carried out to explore opinions and suggestions toward the HCOACDM of the care managers in intervention group. It is expected that the developed HCOACDM will be useful to provide the long-term care for community older adults and enhance the quality of diverse and complex care delivery system.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of a Care Delivery Model for the High-need Community Older Adults
Actual Study Start Date : March 8, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HCOACDM
The intervention, the HCOACDM, involves case screening, comprehensive assessment, and care coordination, and will be given over a 6-month period.
Other: HCOACDM
The intervention, the HCOACDM, involves case screening, comprehensive assessment, and care coordination, and will be given over a 6-month period.

Active Comparator: Routine care
The routine care services include home visits, telephone checkups, meals on the wheel, and health promotion activities.
Other: Routine care
The routine care services include home visits, telephone checkups, meals on the wheel, and health promotion activities.




Primary Outcome Measures :
  1. Functional Ability measured by the Barthel Index (BI) [ Time Frame: 6 months ]
    A 10-item scale that includes feeding, transfers, grooming, toilet use, bathing, mobility, stairs, dressing, and control of bladder and bowel. Score ranges from 0 to 100; the higher the score, the higher the level of self-care independence of an individual: 0-20 = complete dependence, 21-60 = severe dependence, 61-90 = moderate dependence, 91-99 = mild dependence, and 100 = total independence.

  2. Quality of Life measured by the World Health Organization quality of life (WHOQOL-BREF) [ Time Frame: 6 months ]
    A 28-item scale with four dimensions: physical health, psychological health, social relations, and environment. The responses use a 5-point Likert scale; the higher the score, the better the QOL of an individual.

  3. Depressive Symptoms measured by the Hamilton Depression Rating Scale (HDRS) [ Time Frame: 6 months ]
    A 17-item scale uses to assess a client's emotional and physical-psychological status during the past week through a self-report and observations. The total score ranges from 0 to 52: a score > 18 = severe depression, 14-17 = moderate depression, 11-13 = mild depression, 8-10 = borderline depression, and < 7 as normal.


Secondary Outcome Measures :
  1. Healthcare and Social Service Utilizations measured by the Resource Usage of the High-concerned Community Older Adults [ Time Frame: 6 months ]
    Based on the long-term care services that are provided in Taiwan, 21 resources are itemized in 3 categories: 1) care for the client (8 services), 2) social welfare (10 services), and 3) care for the caregiver (3 services). The researcher will mark the services that have been used by the participants.

  2. Satisfaction with Care Delivery measured by the Satisfaction Questionnaire of Service Users to Care Managers [ Time Frame: 6 months ]
    There are three dimensions in the questionnaire (Chiou, 2011), but only the dimensions of professional abilities (5 items) and interpersonal interactions and attitudes (5 items) are adopted in this study. A 5-point Likert scale is used; the higher the score, the more satisfaction a client has with the service provider.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • lived in the community at least three months
  • over 65 years old
  • fluently communicated in Mandarin or Taiwanese
  • screened by the High-need Community Older Adults Screening Scale (HCOASS) as high-need older adults

Exclusion Criteria:

  • diagnosed as dementia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864471


Contacts
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Contact: Kuei-Min Chen, PhD 886-7-3121101 ext 2632 kmc@kmu.edu.tw

Locations
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Taiwan
Community Care Centers Recruiting
Kaohsiung, Taiwan
Contact: Ya-Fe Yang, BS    886-952-777205    yalei8686@yahoo.com.tw   
Sponsors and Collaborators
Kaohsiung Medical University
Ministry of Science and Technology, Taiwan
Investigators
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Principal Investigator: Kuei-Min Chen, PhD Kaohsiung Medical University

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Responsible Party: Kuei-Min Chen, Ph.D., RN., Professor, Kaohsiung Medical University
ClinicalTrials.gov Identifier: NCT03864471     History of Changes
Other Study ID Numbers: KMUHIRB-F(I)-20170070
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No