High-need Older AdultsHCOACDMNCT03864471
High-need Community Older Adults Care Delivery Model
A study testing HCOACDM and Routine care in people with High-need Older Adults, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- High-need Older Adults
- What is being tested?
- HCOACDM and Routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Mar 2019to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- diagnosed as dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Care Delivery Model for the High-need Community Older Adults
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.
Read the 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.
- Conditions
- High-need Older Adults
- Being tested
- HCOACDM, Routine care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCOACDMOther
The intervention, the HCOACDM, involves case screening, comprehensive assessment, and care coordination, and will be given over a 6-month period.
Routine careOther
The routine care services include home visits, telephone checkups, meals on the wheel, and health promotion activities.
| Study group | Role | What they receive |
|---|---|---|
| HCOACDM | Experimental | The intervention, the HCOACDM, involves case screening, comprehensive assessment, and care coordination, and will be given over a 6-month period. Receives: Other: HCOACDM |
| Routine care | Active comparator | The routine care services include home visits, telephone checkups, meals on the wheel, and health promotion activities. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (2)
Healthcare and Social Service Utilizations measured by the Resource Usage of the High-concerned Community Older Adults
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.
Measured: 6 months
Satisfaction with Care Delivery measured by the Satisfaction Questionnaire of Service Users to Care Managers
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start8 Mar 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-need Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Kuei-Min Chen, Ph.D., RN., Kaohsiung Medical University
- Investigators
- Kuei-Min Chen, PhD, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864471
- Sponsor's protocol ID
- KMUHIRB-F(I)-20170070
- Acronym
- HCOACDM
- Status last verified
- Sep 2019
- First submitted
- 2 Mar 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Care Delivery Model for the High-need Community Older Adults
- ClinicalTrials.gov ID
- NCT03864471
- Acronym / sponsor ID
- HCOACDM / KMUHIRB-F(I)-20170070
- Conditions
- High-need Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCOACDM | Experimental | Other: HCOACDMThe intervention, the HCOACDM, involves case screening, comprehensive assessment, and care coordination, and will be given over a 6-month period. |
| Routine care | Active comparator | Other: Routine careThe routine care services include home visits, telephone checkups, meals on the wheel, and health promotion activities. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- diagnosed as dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCOACDMThe intervention, the HCOACDM, involves case screening, comprehensive assessment, and care coordination, and will be given over a 6-month period. | Other | HCOACDM |
| Routine careThe routine care services include home visits, telephone checkups, meals on the wheel, and health promotion activities. | Other | Routine care |
Primary outcome
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.
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.
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.
2 secondary outcomes
Healthcare and Social Service Utilizations measured by the Resource Usage of the High-concerned Community Older Adults
Time frame: 6 months
Satisfaction with Care Delivery measured by the Satisfaction Questionnaire of Service Users to Care Managers
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for High-need Older Adults
Recruiting
Annual Wellness Visits vs GRACE-augmented Annual Wellness Visits For Older Adults With High Needs - Phase 2
Aging, Preventive Care
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuei-Min Chen, PhD principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HCOACDM and Routine care in people with High-need Older Adults, run by Kaohsiung Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Ability measured by the Barthel Index (BI) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.