Primary HealthcareNCT07458841
Nurse-Led Discharge Program and Primary Care Outcomes: A Proof-of-concept Cluster Randomized Controlled Trial
A study testing Primary healthcare discharge education, specially-designed health education leaflet and Patient discharge package in people with Primary Healthcare, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this cluster randomized controlled trial is to evaluate whether a nurse-led primary health care (PHC) discharge intervention can improve patient activation and primary health care-related outcomes among hospitalized adult patients after discharge. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Healthcare
- What is being tested?
- Primary healthcare discharge education, specially-designed health education leaflet and Patient discharge package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hong Kong residents aged ≥18 years
- Able to read and communicate in Chinese (Cantonese or Mandarin)
- Being hospitalized for more than 24 hours
- Stable medical condition upon hospital discharge
Who cannot join
- Having a history of psychiatric/psychological disease or currently on regular psychotropic medications
- Currently participating in other primary healthcare programmes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
18/F, Metro South Tower 1, 39 Wong Chuk Hang Road, Wong Chuk Hang, Hong Kong
Hong Kong, Hong Kong, 000000
Siu Long Chau, PhD, +852 6700 9987, cslmatt@hku.hk
Siu Long Chau, PhD
About this study
Official title: Effectiveness of the Nurse-led Discharge Interventions in Promoting Hospital Patients' Primary Health Care Outcomes on Discharge: A Proof-of-concept Cluster Randomized Controlled Trial
The goal of this cluster randomized controlled trial is to evaluate whether a nurse-led primary health care (PHC) discharge intervention can improve patient activation and primary health care-related outcomes among hospitalized adult patients after discharge.
Read the detailed description
Chronic diseases account for approximately 74% of global deaths and remain the leading cause of morbidity and mortality worldwide and in Hong Kong, particularly ischemic heart disease, cerebrovascular disease, and diabetes-related complications. The growing burden of ageing populations and non-communicable diseases highlights the need to shift healthcare systems from secondary and tertiary care toward prevention-oriented primary health care (PHC).
PHC serves as the first point of contact in a continuous healthcare process and is essential to a sustainable healthcare system. In response, Hong Kong is implementing a PHC reform through the establishment of District Health Centres to enhance population health and reduce pressure on public hospitals. Nurses, as the largest healthcare workforce, play a critical role in PHC delivery; however, nursing training in Hong Kong remains predominantly hospital-focused. Strengthening hospital nurses' roles in PHC-oriented discharge education may improve care continuity, patient self-management, and long-term health outcomes while reducing hospital readmissions and healthcare costs.
The aims of study are as follows:
- To determine the main effect of the Intervention vs. Control group on Patient Activation Measure at 3-month follow-up after discharge (Primary)
- To assess the effects on secondary outcomes at 3-month and 6-month follow-ups
- To identify mediators between intervention and outcomes to inform the potential mechanisms
- To qualitatively explore subjects' perceptions of managing their own health conditions after leaving the hospital and their experience of following the primary healthcare discharge intervention suggested by nurses.
- Conditions
- Primary Healthcare
- Being tested
- Primary healthcare discharge education, specially-designed health education leaflet, Patient discharge package, usual hospital discharge practice
- Keywords
- nurse-led discharge intervention, primary healthcare, cluster randomized controlled trail
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary healthcare discharge educationBehavioural
The primary healthcare discharge education begins by identifying priorities to address related to patients' life situations (using the Instrument for Patient Capacity Assessment) and determining the patient's current level of activation (using the Patient Activation Measure). A discharge education guide developed by the research team helps to individualize the teaching according to the patient's priorities and activation level.
specially-designed health education leafletBehavioural
- Introduction of the District Health Centres/Expresses;
- Life Course Preventive Care Plan pamphlet;
- Provide disease-specific discharge/rehabilitation advice and relevant health education materials with an emphasis on prevention and self-care management;
- The hospital nurses will help discharge patients download and install the "HA Go" mobile app.
Patient discharge packageBehavioural
Subjects in the intervention group will receive the following items with instructions for use upon hospital discharge:
- Blood pressure monitor
- Blood glucose test strip
- Soft ruler to measure weight circumference
- Resistance bands for simple exercise
usual hospital discharge practiceBehavioural
The control group will receive the usual hospital discharge practice upon discharge.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 1. primary healthcare discharge education
2. specially-designed health education leaflet
3. patient discharge package Receives: Behavioral: Primary healthcare discharge education; Behavioral: specially-designed health education leaflet; Behavioral: Patient discharge package |
| Control Group | Active comparator | usual hospital discharge practice Receives: Behavioral: usual hospital discharge practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the change in the Patient Activation Measure (PAM) between baseline and 3-month follow-up.
The PAM is a 13-item self-report questionnaire to measure patient activation level [18]. Patients can go through four levels of activation: (1) disengaged and overwhelmed, (2) becoming aware but still struggling, (3) taking action, and (4) maintaining behaviors and pushing further [18].PAM raw score can be calculated by adding all of the responses to the 13 questions [18]. This score is then converted into an activation score ranging from 0 = no activation to 100 = high activation using a scoresheet provided by Insignia Health.
Measured: From baseline to 3-month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Primary HealthcareStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Responsible party
- Sponsor
- Investigators
- Siu Long Chau, PhD, Principal investigator, HKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458841
- Sponsor's protocol ID
- currently not available
- Status last verified
- Jan 2026
- First submitted
- 4 Mar 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Merkow RP, Kaji AH, Itani KMF. The CONSORT Framework. JAMA Surg. 2021 Sep 1;156(9):877-878. doi: 10.1001/jamasurg.2021.0549. No abstract available.
PubMed 33825818Rowland E, Conolly A. A worked example of contextualising and using reflexive thematic analysis in nursing research. Nurse Res. 2024 Dec 11;32(4):17-27. doi: 10.7748/nr.2024.e1924. Epub 2024 Aug 29.
PubMed 39206491Duarte MP, Vieira FA, Baiao VM, Monteiro JS, Ferreira AP, Inda-Filho AJ, Nobrega OT, Ribeiro HS. The 10-Item Physical Function Scale as a Sarcopenia Screening Tool for Patients on Hemodialysis. J Ren Nutr. 2024 Nov;34(6):546-551. doi: 10.1053/j.jrn.2024.05.012. Epub 2024 Jun 5.
PubMed 38848807Ingram PB 4th, Clarke E, Lichtenberg JW. Confirmatory Factor Analysis of the Perceived Stress Scale-4 in a Community Sample. Stress Health. 2016 Apr;32(2):173-6. doi: 10.1002/smi.2592. Epub 2014 Jul 4.
PubMed 24995556Adzrago D, Walker TJ, Williams F. Reliability and validity of the Patient Health Questionnaire-4 scale and its subscales of depression and anxiety among US adults based on nativity. BMC Psychiatry. 2024 Mar 18;24(1):213. doi: 10.1186/s12888-024-05665-8.
PubMed 38500115Shmueli A. The Visual Analog rating Scale of health-related quality of life: an examination of end-digit preferences. Health Qual Life Outcomes. 2005 Nov 14;3:71. doi: 10.1186/1477-7525-3-71.
PubMed 16285884Weiss ME, Piacentine LB. Psychometric properties of the Readiness for Hospital Discharge Scale. J Nurs Meas. 2006 Winter;14(3):163-80. doi: 10.1891/jnm-v14i3a002.
PubMed 17278337Benson T, Potts HWW, Bark P, Bowman C. Development and initial testing of a Health Confidence Score (HCS). BMJ Open Qual. 2019 Jun 7;8(2):e000411. doi: 10.1136/bmjoq-2018-000411. eCollection 2019.
PubMed 31259277Chalmers KI, Luker KA, Bramadat IJ. Students' knowledge of and attitudes towards primary health care. Nurse Educ Today. 1998 Jul;18(5):399-405. doi: 10.1016/0021-8634(92)80010-p.
PubMed 9847729Schmaderer M, Pozehl B, Hertzog M, Zimmerman L. Psychometric Properties of the Patient Activation Measure in Multimorbid Hospitalized Patients. J Nurs Meas. 2015;23(3):128-41. doi: 10.1891/1061-3749.23.3.E128.
PubMed 26673761French SD, Green SE, O'Connor DA, McKenzie JE, Francis JJ, Michie S, Buchbinder R, Schattner P, Spike N, Grimshaw JM. Developing theory-informed behaviour change interventions to implement evidence into practice: a systematic approach using the Theoretical Domains Framework. Implement Sci. 2012 Apr 24;7:38. doi: 10.1186/1748-5908-7-38.
PubMed 22531013Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.
PubMed 21513547Atkins L, Francis J, Islam R, O'Connor D, Patey A, Ivers N, Foy R, Duncan EM, Colquhoun H, Grimshaw JM, Lawton R, Michie S. A guide to using the Theoretical Domains Framework of behaviour change to investigate implementation problems. Implement Sci. 2017 Jun 21;12(1):77. doi: 10.1186/s13012-017-0605-9.
PubMed 28637486Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
PubMed 15230939Chau SL, Luk TT, Wong BYC, Wu YS, Cheung YTD, Ho SY, Kim JH, Lo HHM, Lam TH, Wang MP. A Brief Intervention With Instant Messaging or Regular Text Messaging Support in Reducing Alcohol Use: A Randomized Clinical Trial. JAMA Intern Med. 2024 Jun 1;184(6):641-649. doi: 10.1001/jamainternmed.2024.0343.
PubMed 38587827
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Nurse-led Discharge Interventions in Promoting Hospital Patients' Primary Health Care Outcomes on Discharge: A Proof-of-concept Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07458841
- Acronym / sponsor ID
- currently not available
- Conditions
- Primary Healthcare
- Keywords
- nurse-led discharge intervention, primary healthcare, cluster randomized controlled trail
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 9 Mar 2026 (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.
The goal of this cluster randomized controlled trial is to evaluate whether a nurse-led primary health care (PHC) discharge intervention can improve patient activation and primary health care-related outcomes among hospitalized adult patients after discharge.
Detailed description
Chronic diseases account for approximately 74% of global deaths and remain the leading cause of morbidity and mortality worldwide and in Hong Kong, particularly ischemic heart disease, cerebrovascular disease, and diabetes-related complications. The growing burden of ageing populations and non-communicable diseases highlights the need to shift healthcare systems from secondary and tertiary care toward prevention-oriented primary health care (PHC).
PHC serves as the first point of contact in a continuous healthcare process and is essential to a sustainable healthcare system. In response, Hong Kong is implementing a PHC reform through the establishment of District Health Centres to enhance population health and reduce pressure on public hospitals. Nurses, as the largest healthcare workforce, play a critical role in PHC delivery; however, nursing training in Hong Kong remains predominantly hospital-focused. Strengthening hospital nurses' roles in PHC-oriented discharge education may improve care continuity, patient self-management, and long-term health outcomes while reducing hospital readmissions and healthcare costs.
The aims of study are as follows:
- To determine the main effect of the Intervention vs. Control group on Patient Activation Measure at 3-month follow-up after discharge (Primary)
- To assess the effects on secondary outcomes at 3-month and 6-month follow-ups
- To identify mediators between intervention and outcomes to inform the potential mechanisms
- To qualitatively explore subjects' perceptions of managing their own health conditions after leaving the hospital and their experience of following the primary healthcare discharge intervention suggested by nurses.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Primary healthcare discharge education, Behavioral: specially-designed health education leaflet, Behavioral: Patient discharge package1. primary healthcare discharge education 2. specially-designed health education leaflet 3. patient discharge package |
| Control Group | Active comparator | Behavioral: usual hospital discharge practiceusual hospital discharge practice |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Hong Kong residents aged ≥18 years
- Able to read and communicate in Chinese (Cantonese or Mandarin)
- Being hospitalized for more than 24 hours
- Stable medical condition upon hospital discharge
Key exclusion criteria (2 listed)
- Having a history of psychiatric/psychological disease or currently on regular psychotropic medications
- Currently participating in other primary healthcare programmes
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 |
|---|---|---|
| Primary healthcare discharge educationThe primary healthcare discharge education begins by identifying priorities to address related to patients' life situations (using the Instrument for Patient Capacity Assessment) and determining the patient's current level of activation (using the Patient Activation Measure). A discharge education guide developed by the research team helps to individualize the teaching according to the patient's priorities and activation level. | Behavioural | Intervention group |
| specially-designed health education leaflet1. Introduction of the District Health Centres/Expresses; 2. Life Course Preventive Care Plan pamphlet; 3. Provide disease-specific discharge/rehabilitation advice and relevant health education materials with an emphasis on prevention and self-care management; 4. The hospital nurses will help discharge patients download and install the "HA Go" mobile app. | Behavioural | Intervention group |
| Patient discharge packageSubjects in the intervention group will receive the following items with instructions for use upon hospital discharge: 1. Blood pressure monitor 2. Blood glucose test strip 3. Soft ruler to measure weight circumference 4. Resistance bands for simple exercise | Behavioural | Intervention group |
| usual hospital discharge practiceThe control group will receive the usual hospital discharge practice upon discharge. | Behavioural | Control Group |
Primary outcome
The primary outcome is the change in the Patient Activation Measure (PAM) between baseline and 3-month follow-up.
Time frame: From baseline to 3-month follow up.
The PAM is a 13-item self-report questionnaire to measure patient activation level [18]. Patients can go through four levels of activation: (1) disengaged and overwhelmed, (2) becoming aware but still struggling, (3) taking action, and (4) maintaining behaviors and pushing further [18].PAM raw score can be calculated by adding all of the responses to the 13 questions [18]. This score is then converted into an activation score ranging from 0 = no activation to 100 = high activation using a scoresheet provided by Insignia Health.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Background: PubMed 33825818Merkow RP, Kaji AH, Itani KMF. The CONSORT Framework. JAMA Surg. 2021 Sep 1;156(9):877-878. doi: 10.1001/jamasurg.2021.0549. No abstract available.
- Background: PubMed 39206491Rowland E, Conolly A. A worked example of contextualising and using reflexive thematic analysis in nursing research. Nurse Res. 2024 Dec 11;32(4):17-27. doi: 10.7748/nr.2024.e1924. Epub 2024 Aug 29.
- Background: PubMed 38848807Duarte MP, Vieira FA, Baiao VM, Monteiro JS, Ferreira AP, Inda-Filho AJ, Nobrega OT, Ribeiro HS. The 10-Item Physical Function Scale as a Sarcopenia Screening Tool for Patients on Hemodialysis. J Ren Nutr. 2024 Nov;34(6):546-551. doi: 10.1053/j.jrn.2024.05.012. Epub 2024 Jun 5.
- Background: PubMed 24995556Ingram PB 4th, Clarke E, Lichtenberg JW. Confirmatory Factor Analysis of the Perceived Stress Scale-4 in a Community Sample. Stress Health. 2016 Apr;32(2):173-6. doi: 10.1002/smi.2592. Epub 2014 Jul 4.
- Background: PubMed 38500115Adzrago D, Walker TJ, Williams F. Reliability and validity of the Patient Health Questionnaire-4 scale and its subscales of depression and anxiety among US adults based on nativity. BMC Psychiatry. 2024 Mar 18;24(1):213. doi: 10.1186/s12888-024-05665-8.
- Background: PubMed 16285884Shmueli A. The Visual Analog rating Scale of health-related quality of life: an examination of end-digit preferences. Health Qual Life Outcomes. 2005 Nov 14;3:71. doi: 10.1186/1477-7525-3-71.
- Background: PubMed 17278337Weiss ME, Piacentine LB. Psychometric properties of the Readiness for Hospital Discharge Scale. J Nurs Meas. 2006 Winter;14(3):163-80. doi: 10.1891/jnm-v14i3a002.
- Background: PubMed 31259277Benson T, Potts HWW, Bark P, Bowman C. Development and initial testing of a Health Confidence Score (HCS). BMJ Open Qual. 2019 Jun 7;8(2):e000411. doi: 10.1136/bmjoq-2018-000411. eCollection 2019.
- Background: PubMed 9847729Chalmers KI, Luker KA, Bramadat IJ. Students' knowledge of and attitudes towards primary health care. Nurse Educ Today. 1998 Jul;18(5):399-405. doi: 10.1016/0021-8634(92)80010-p.
- Background: PubMed 26673761Schmaderer M, Pozehl B, Hertzog M, Zimmerman L. Psychometric Properties of the Patient Activation Measure in Multimorbid Hospitalized Patients. J Nurs Meas. 2015;23(3):128-41. doi: 10.1891/1061-3749.23.3.E128.
- Background: PubMed 22531013French SD, Green SE, O'Connor DA, McKenzie JE, Francis JJ, Michie S, Buchbinder R, Schattner P, Spike N, Grimshaw JM. Developing theory-informed behaviour change interventions to implement evidence into practice: a systematic approach using the Theoretical Domains Framework. Implement Sci. 2012 Apr 24;7:38. doi: 10.1186/1748-5908-7-38.
- Background: PubMed 21513547Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.
- Individual participant dataSharing planned: No
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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.
Siu Long Chau, PhD principal investigator
HKU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary healthcare discharge education, specially-designed health education leaflet and Patient discharge package in people with Primary Healthcare, run by The University of Hong Kong at 1 site in Hong Kong.
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 2 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: opening soon, as of the sponsor's last update on 9 Mar 2026. 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siu Long Chau, PhD (+852 6700 9987, cslmatt@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the change in the Patient Activation Measure (PAM) between baseline and 3-month follow-up. (time frame: From baseline to 3-month follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07458841, which also lists 26 linked publications.
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 9 Mar 2026.