<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04434742</url>
  </required_header>
  <id_info>
    <org_study_id>HSP002</org_study_id>
    <nct_id>NCT04434742</nct_id>
  </id_info>
  <brief_title>The Effects of a Health-social Partnership Program for Discharged Non-frail Older Adults</brief_title>
  <official_title>The Effects of a Health-social Partnership Program for Discharged Non-frail Older Adults: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Queen Elizabeth Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous studies supporting discharged patients are hospital-based which admission criteria&#xD;
      tend to include mainly those with complex needs and/or specific disease conditions. This&#xD;
      study captured the service gap where these non-frail older patients might have no specific&#xD;
      medical problem upon discharge but they might encounter residual health and social issues&#xD;
      when returning home.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To compare the effect of a community-based health-social partnership program with&#xD;
      usual care for discharged community-dwelling non-frail older adults on their health-related&#xD;
      quality of life, activities of daily living, depressive symptoms, and use of health services.&#xD;
&#xD;
      Design: A randomized controlled trial. Participants: Discharged community-dwelling non-frail&#xD;
      older adults from an emergency medical ward in an intervention (n=37) and a control (n=38)&#xD;
      group.&#xD;
&#xD;
      Interventions: Discharged older adults were randomized to receive usual care or complex&#xD;
      interventions, including structured assessment, health education, goal empowerment, and care&#xD;
      coordination supported by a health-social team.&#xD;
&#xD;
      Main measures: The outcomes were measured at pre-intervention (T1) and at three months&#xD;
      post-intervention (T2) using the Medical Outcomes Study 12-item Short Form, the Modified&#xD;
      Barthel Index and the Geriatric Depression Scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2017</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline Health-related quality of life: SF-12 at 3 months</measure>
    <time_frame>At baseline pre-intervention and at three months when the interventions were completed.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Activity of daily living at 3 months</measure>
    <time_frame>At baseline pre-intervention and at three months when the interventions were completed.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Presence of depressive symptoms at 3 months</measure>
    <time_frame>At baseline pre-intervention and at three months when the interventions were completed.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>At baseline pre-intervention and at three months when the interventions were completed.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Transition</condition>
  <condition>Partner Communication</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects in this group receive complex interventions, including structured assessment, health education, goal empowerment, and care coordination supported by a health-social team.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Complex interventions</intervention_name>
    <description>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.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Social call was given to this group.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  resided in the service areas of the study hospital,&#xD;
&#xD;
          -  were aged 60 or over,&#xD;
&#xD;
          -  were cognitively competent with a score greater than 26 in the Montreal Cognitive&#xD;
             Assessment Hong Kong version,&#xD;
&#xD;
          -  were living at home before and after discharge from the hospital,&#xD;
&#xD;
          -  had scores of &lt;5 on the Clinical Frailty Scale (Note: a patient is considered to be&#xD;
             non-frail if they have a score less than 5), and&#xD;
&#xD;
          -  were fit for medical discharge&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  were not able to communicate,&#xD;
&#xD;
          -  could not be reached by phone,&#xD;
&#xD;
          -  were bed-bound,&#xD;
&#xD;
          -  had active psychiatric problems,&#xD;
&#xD;
          -  were already engaged in other structured health or social programs, and&#xD;
&#xD;
          -  would not be staying in Hong Kong for the three months of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arkers KC Wong, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>Kowloon</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 13, 2020</last_update_submitted>
  <last_update_submitted_qc>June 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>Arkers, Wong</investigator_full_name>
    <investigator_title>Clinical associate</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04434742
org study id: HSP002
nct id: NCT04434742
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: 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.
description: 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.
measure: 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.
description: 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.
measure: 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.
description: 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.
measure: 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.
description: 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.
arm group label: Intervention group
arm group type: Experimental
description: The subjects in this group receive complex interventions, including structured assessment, health education, goal empowerment, and care coordination supported by a health-social team.
arm group label: Control group
arm group type: Other
description: 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.
intervention type: Other
intervention name: Complex interventions
description: 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.
arm group label: Intervention group
intervention type: Other
intervention name: Usual care
description: Social call was given to this group.
arm group label: Control group
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Arkers KC Wong, Dr
role: Principal Investigator
affiliation: The Hong Kong Polytechnic University
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: Arkers, Wong
investigator title: Clinical associate
sharing ipd: No
ipd description: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.