NCT03864471

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

March 8, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

7 months

First QC Date

March 2, 2019

Last Update Submit

September 30, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Functional Ability measured by the Barthel Index (BI)

    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.

    6 months

  • Quality of Life measured by the World Health Organization quality of life (WHOQOL-BREF)

    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.

    6 months

  • Depressive Symptoms measured by the Hamilton Depression Rating Scale (HDRS)

    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.

    6 months

Secondary Outcomes (2)

  • Healthcare and Social Service Utilizations measured by the Resource Usage of the High-concerned Community Older Adults

    6 months

  • Satisfaction with Care Delivery measured by the Satisfaction Questionnaire of Service Users to Care Managers

    6 months

Study Arms (2)

HCOACDM

EXPERIMENTAL

The intervention, the HCOACDM, involves case screening, comprehensive assessment, and care coordination, and will be given over a 6-month period.

Other: HCOACDM

Routine care

ACTIVE COMPARATOR

The routine care services include home visits, telephone checkups, meals on the wheel, and health promotion activities.

Other: Routine care

Interventions

HCOACDMOTHER

The intervention, the HCOACDM, involves case screening, comprehensive assessment, and care coordination, and will be given over a 6-month period.

HCOACDM

The routine care services include home visits, telephone checkups, meals on the wheel, and health promotion activities.

Routine care

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • diagnosed as dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Care Centers

Kaohsiung City, Taiwan

Location

Study Officials

  • Kuei-Min Chen, PhD

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 2, 2019

First Posted

March 6, 2019

Study Start

March 8, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

October 1, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations