We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of a Health-social Partnership Program for Discharged Non-frail Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04434742
Recruitment Status : Completed
First Posted : June 17, 2020
Last Update Posted : June 17, 2020
Sponsor:
Collaborator:
The Queen Elizabeth Hospital
Information provided by (Responsible Party):
Arkers, Wong, The Hong Kong Polytechnic University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Previous studies supporting discharged patients are hospital-based which admission criteria tend to include mainly those with complex needs and/or specific disease conditions. This study captured the service gap where these non-frail older patients might have no specific medical problem upon discharge but they might encounter residual health and social issues when returning home.

Condition or disease Intervention/treatment Phase
Transition Partner Communication Other: Complex interventions Other: Usual care Not Applicable

Detailed Description:

Objective: To compare the effect of a community-based health-social partnership program with usual care for discharged community-dwelling non-frail older adults on their health-related quality of life, activities of daily living, depressive symptoms, and use of health services.

Design: A randomized controlled trial. Participants: Discharged community-dwelling non-frail older adults from an emergency medical ward in an intervention (n=37) and a control (n=38) group.

Interventions: Discharged older adults were randomized to receive usual care or complex interventions, including structured assessment, health education, goal empowerment, and care coordination supported by a health-social team.

Main measures: The outcomes were measured at pre-intervention (T1) and at three months post-intervention (T2) using the Medical Outcomes Study 12-item Short Form, the Modified Barthel Index and the Geriatric Depression Scale.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of a Health-social Partnership Program for Discharged Non-frail Older Adults: a Pilot Study
Actual Study Start Date : June 19, 2017
Actual Primary Completion Date : April 30, 2020
Actual Study Completion Date : April 30, 2020
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Intervention group
The subjects in this group receive complex interventions, including structured assessment, health education, goal empowerment, and care coordination supported by a health-social team.
 Other: Complex interventions
An advanced practice nurse (APN) from a hospital discharge team visited them to familiarize him/herself with their condition and prepare a discharge plan. A face-to-face or telephone call handover between the APN and the project nurse case manager (NCM) was performed before the client was discharged. The past and current medical conditions, medical and nursing management, and follow-up appointments were discussed. After discharge home, the NCM, functioning as the leader of health-social care team, conducted the initial assessment in the first home visit to identify the client's health and social problems within one week of discharge. Community workers, supervised by both the nurse case manager and social worker, provided telephone follow-up and subsequent home visits to monitor the client's progress and provide support when necessary.
Control group
The control group received usual discharge care and community resources that were made available to them as appropriate. A monthly social call was made to each client in the control group in order to exclude social effects. The contents of the social call, such as asking about entertainment and clients' hobbies, were set in the protocol.
 Other: Usual care
Social call was given to this group.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change from baseline Health-related quality of life: SF-12 at 3 months [ Time Frame: At baseline pre-intervention and at three months when the interventions were completed. ]
    The goal for this program was to enable older adults to live with optimum quality of life in their own environment through receiving support from the collaboration of nurse case managers and social workers. Quality of life was measured by SF-12, which has been shown to be useful in Chinese elderly patients. The questionnaire has 12 items organized into eight categories (physical functioning, role limitation due to emotional and physical problems, mental health scale, general health, bodily pain, social functioning, and vitality), and has been validated in numerous studies.


Secondary Outcome Measures :
  1. Change from baseline Activity of daily living at 3 months [ Time Frame: At baseline pre-intervention and at three months when the interventions were completed. ]
    Use Modified Barthel index to measure the subjects' ability to do basic activity of daily livings such as grooming, eating, and walking. The score is from 0-100, with higher scores representing better activity of daily living.

  2. Change from baseline Presence of depressive symptoms at 3 months [ Time Frame: At baseline pre-intervention and at three months when the interventions were completed. ]
    The presence of depressive symptoms was measured by the Geriatric Depression Scale. The scores from each item are summed up. The maximum score is 15, with higher scores representing higher severity of depressive symptoms. Good validity and reliability have been reported in this scale, with criterion-related validity 0.95 and test-retest reliability 0.85 among the older Chinese population.

  3. Change from Total number of unplanned outpatient department, general practitioner, and emergency department visits, hospital admissions and total number of health service attendances at 3 months [ Time Frame: At baseline pre-intervention and at three months when the interventions were completed. ]
    This information was collected from the subjective reports of participants. They were asked about the number of attendances within the last three months prior to both T1 and T2 data collection.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • resided in the service areas of the study hospital,
  • were aged 60 or over,
  • were cognitively competent with a score greater than 26 in the Montreal Cognitive Assessment Hong Kong version,
  • were living at home before and after discharge from the hospital,
  • had scores of <5 on the Clinical Frailty Scale (Note: a patient is considered to be non-frail if they have a score less than 5), and
  • were fit for medical discharge

Exclusion Criteria:

  • were not able to communicate,
  • could not be reached by phone,
  • were bed-bound,
  • had active psychiatric problems,
  • were already engaged in other structured health or social programs, and
  • would not be staying in Hong Kong for the three months of the study
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04434742


Locations
Layout table for location information
Hong Kong
Queen Elizabeth Hospital
Kowloon, Hong Kong
Sponsors and Collaborators
The Hong Kong Polytechnic University
The Queen Elizabeth Hospital
Investigators
Layout table for investigator information
Principal Investigator: Arkers KC Wong, Dr The Hong Kong Polytechnic University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Arkers, Wong, Clinical associate, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT04434742    
Other Study ID Numbers: HSP002
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No