End Stage Heart DiseaseNCT02086305
Transitional Palliative Care in End-stage Heart Failure
A study testing Transitional Care Model in people with End Stage Heart Disease and Heart Failure, run by The Hong Kong Polytechnic University at 3 sites in Hong Kong.
Trial summary
Palliative care for end-stage organ failure patients has been included as one of the key programs to be implemented in 2011-2012 in the Hospital Authority, Hong Kong. Among all the disease groups, end-stage heart failure patients have the highest mortality rate. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Heart Disease, Heart Failure
- What is being tested?
- Transitional Care Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 3 sitesHong Kong
- Study dates
- Jan 2013to Dec 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ability to speak Cantonese
- Living within the hospital service area
- Ability to be contacted by phone
- Identified as end-stage heart failure eligible for palliative care, guided by Prognostic Indicator Guidance, National Gold Standards Framework,to fulfill at least two of the indicators below:
- Congestive heart failure New York Heart Association stage III or IV (ii) Patient thought to be in the last year of life by the care team (iii) Repeated hospital admissions with symptoms of heart failure (3 hospital admissions within one year) (iv) Existence of physical or psychological symptoms despite optimal tolerated therapy
Who cannot join
- Discharged to nursing home or other institution
- Inability to communicate
- Diagnosed with severe psychiatric disorders such as schizophrenia, bipolar disorder
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
Grantham Hospital
Hong Kong
Haven Of Hope Hospital
Hong Kong
United Christian Hospital
Hong Kong
About this study
Official title: Effects of a Transitional Palliative Care Model on Patients With End-stage Heart Failure
Palliative care for end-stage organ failure patients has been included as one of the key programs to be implemented in 2011-2012 in the Hospital Authority, Hong Kong. Among all the disease groups, end-stage heart failure patients have the highest mortality rate. Patients at the end stage of heart failure have health concerns shared by other end-stage patients including cancer patients. Many guidelines, local and world-wide, have advocated a palliative approach of care for those heart failure patients who are at end stage. Studies have shown that end-stage heart failure patients tend to have frequent emergency room visits and repeated hospital admissions. Also, these patients suffer from a number of health problems that adversely affect their Quality Of Life.
There is scarcity of experimental studies informing practitioners which models work best for palliative patients in Hong Kong. There were randomized controlled trials conducted outside Hong Kong which suggest multidisciplinary approach of palliative care is possible to reduce readmissions but evidence is not present for other outcomes such as symptom control and carer burden.
Read more
In an attempt to fill knowledge gap and inform practice using evidence, this study is launched to compare the effects of a customary hospital-based palliative heart failure care and an interventional Home-based Palliative heart failure Program.
Hypothesis
- there is no difference in health care utilization for end-stage heart failure patients between the customary hospital-based group and the Home based palliative heart failure program group
- there is no difference in evaluated health outcomes (functional status, symptom intensity, and satisfaction with care) between the customary hospital-based group and the Home based palliative heart failure program group
- there is no difference in perceived health outcomes (quality of life, caregiver burden) between the customary hospital-based group and the Home based palliative heart failure program group
- there is no difference in cost effectiveness between the customary hospital-based group and the Home based palliative heart failure program group
- there is no difference In patients' lived experiences between the customary hospital-based group and the Home based palliative heart failure program group
Read the detailed description
As described
- Conditions
- End Stage Heart Disease, Heart Failure
- Being tested
- Transitional Care Model, Usual care
- Keywords
- Transitional care, Supportive and palliative care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitional Care ModelBehavioural
Symptom assessment and management, care goal setting, post-discharge support
Usual careBehavioural
Usual care is the routine practice in the hospital
| Study group | Role | What they receive |
|---|---|---|
| Usual Care + Transitional Care Model | Experimental | Transitional Care, Evidence-based symptom management, Protocol-driven home visit and telephone follow-up, Trained nurse case manager and volunteer partnership Receives: Behavioral: Transitional Care Model; Behavioral: Usual care |
| Usual Care | Active comparator | Usual care Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare utilization
The time from hospital discharge to hospital readmission using hospital clinical management system to retrieve data
Measured: up to 12 months
Secondary outcomes (6)
Quality of Life
Change from baseline in quality of life on the palliative specific McGill Quality of Life Questionnaire Hong Kong version (MQOL-HK) at 1 month; change from baseline in MQOL-HK at 3 months; change from baseline in MQOL-HK at 6 months; change from baseline in MQOL-HK at 12 months
Measured: baseline, 1 month, 3 months, 6 months, 12 month
Quality of Life
Change from baseline in quality of life on the heart failure specific Chronic Heart Failure Questionnaire-Chinese version (CHQ) at 1 month; change from baseline in CHQ score at 3 months; change from baseline in CHQ score at 6 months; change from baseline in CHQ score at 12 months
Measured: Baseline, 1 month, 3 months, 6 months, 12 months
Functional status
Change from baseline in functional status on the Palliative Performance Scale (PPS) at 1 month; change from baseline in PPS at 3 months; change from baseline in PPS at 6 months; change from baseline in PPS at 12 months
Measured: Baseline, 1 month, 3 months, 6 months, 12 months
Symptom intensity
Change from baseline in symptom intensity on the Edmonton Symptom Assessment System (ESAS) at 1 month; change from baseline in ESAS score at 3 month; change from baseline in ESAS score at 6 month; change from baseline in ESAS score at 12 month.
Measured: Baseline, 1 month, 3 month, 6 month, 12 month
Satisfaction with care
Change from 1 month in satisfaction with care on the 15-item questionnaire developed by the principal investigator which validity confirmed by an expert panel and reported test-retest reliability of .87 (Sat-care) at 3 month; change from 1 month in Sat-care score at 6 months; change from 1 month in Sat-care score at 12 months
Measured: 1 month, 3 months, 6 months, 12 months
Caregiver burden
Change from baseline in caregiver burden on the Zarit Caregiver Burden Scale (ZCBS) at 1 month; change from baseline in ZCBS score at 3 months; change from baseline in ZCBS score at 6 months; change from baseline in ZCBS score at 12 months
Measured: Baseline, 1 month, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startJan 2013
- Primary completionFeb 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Heart DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frances Kam Yuet WONG, The Hong Kong Polytechnic University
- Investigators
- Frances KY Wong, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086305
- Sponsor's protocol ID
- PolyU5492
- Status last verified
- Aug 2017
- First submitted
- 7 Mar 2014
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wong FKY, So C, Ng AYM, Lam PT, Ng JSC, Ng NHY, Chau J, Sham MMK. Cost-effectiveness of a transitional home-based palliative care program for patients with end-stage heart failure. Palliat Med. 2018 Feb;32(2):476-484. doi: 10.1177/0269216317706450. Epub 2017 Apr 24.
PubMed 28434275Ng AY, Wong FK, Lee PH. Effects of a transitional palliative care model on patients with end-stage heart failure: study protocol for a randomized controlled trial. Trials. 2016 Mar 31;17:173. doi: 10.1186/s13063-016-1303-7.
PubMed 27037096
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Transitional Palliative Care Model on Patients With End-stage Heart Failure
- ClinicalTrials.gov ID
- NCT02086305
- Acronym / sponsor ID
- PolyU5492
- Conditions
- End Stage Heart Disease, Heart Failure
- Keywords
- Transitional care, Supportive and palliative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Mar 2014 (estimated)
- 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.
Palliative care for end-stage organ failure patients has been included as one of the key programs to be implemented in 2011-2012 in the Hospital Authority, Hong Kong. Among all the disease groups, end-stage heart failure patients have the highest mortality rate. Patients at the end stage of heart failure have health concerns shared by other end-stage patients including cancer patients. Many guidelines, local and world-wide, have advocated a palliative approach of care for those heart failure patients who are at end stage. Studies have shown that end-stage heart failure patients tend to have frequent emergency room visits and repeated hospital admissions. Also, these patients suffer from a number of health problems that adversely affect their Quality Of Life.
There is scarcity of experimental studies informing practitioners which models work best for palliative patients in Hong Kong. There were randomized controlled trials conducted outside Hong Kong which suggest multidisciplinary approach of palliative care is possible to reduce readmissions but evidence is not present for other outcomes such as symptom control and carer burden.
In an attempt to fill knowledge gap and inform practice using evidence, this study is launched to compare the effects of a customary hospital-based palliative heart failure care and an interventional Home-based Palliative heart failure Program.
Hypothesis
- there is no difference in health care utilization for end-stage heart failure patients between the customary hospital-based group and the Home based palliative heart failure program group
- there is no difference in evaluated health outcomes (functional status, symptom intensity, and satisfaction with care) between the customary hospital-based group and the Home based palliative heart failure program group
- there is no difference in perceived health outcomes (quality of life, caregiver burden) between the customary hospital-based group and the Home based palliative heart failure program group
- there is no difference in cost effectiveness between the customary hospital-based group and the Home based palliative heart failure program group
- there is no difference In patients' lived experiences between the customary hospital-based group and the Home based palliative heart failure program group
Detailed description
As described
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care + Transitional Care Model | Experimental | Behavioral: Transitional Care Model, Behavioral: Usual careTransitional Care, Evidence-based symptom management, Protocol-driven home visit and telephone follow-up, Trained nurse case manager and volunteer partnership |
| Usual Care | Active comparator | Behavioral: Usual careUsual care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to speak Cantonese
- Living within the hospital service area
- Ability to be contacted by phone
- Identified as end-stage heart failure eligible for palliative care, guided by Prognostic Indicator Guidance, National Gold Standards Framework,to fulfill at least two of the indicators below:
Key exclusion criteria (3 listed)
- Discharged to nursing home or other institution
- Inability to communicate
- Diagnosed with severe psychiatric disorders such as schizophrenia, bipolar disorder
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 |
|---|---|---|
| Transitional Care ModelSymptom assessment and management, care goal setting, post-discharge support | Behavioural | Usual Care + Transitional Care Model |
| Usual careUsual care is the routine practice in the hospital | Behavioural | Usual Care, Usual Care + Transitional Care Model |
Primary outcome
Healthcare utilization
Time frame: up to 12 months
The time from hospital discharge to hospital readmission using hospital clinical management system to retrieve data
6 secondary outcomes
Quality of Life
Time frame: baseline, 1 month, 3 months, 6 months, 12 month
Quality of Life
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months
Functional status
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months
Symptom intensity
Time frame: Baseline, 1 month, 3 month, 6 month, 12 month
Satisfaction with care
Time frame: 1 month, 3 months, 6 months, 12 months
Caregiver burden
Time frame: Baseline, 1 month, 3 months, 6 months, 12 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 22 Aug 2017.
- Derived from this study: PubMed 28434275Wong FKY, So C, Ng AYM, Lam PT, Ng JSC, Ng NHY, Chau J, Sham MMK. Cost-effectiveness of a transitional home-based palliative care program for patients with end-stage heart failure. Palliat Med. 2018 Feb;32(2):476-484. doi: 10.1177/0269216317706450. Epub 2017 Apr 24.
- Derived from this study: PubMed 27037096Ng AY, Wong FK, Lee PH. Effects of a transitional palliative care model on patients with end-stage heart failure: study protocol for a randomized controlled trial. Trials. 2016 Mar 31;17:173. doi: 10.1186/s13063-016-1303-7.
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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. This study is not recruiting at the moment.
Frances KY Wong principal investigator
The Hong Kong Polytechnic University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transitional Care Model in people with End Stage Heart Disease and Heart Failure, run by The Hong Kong Polytechnic University at 3 sites 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 5 inclusion and 3 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 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Healthcare utilization (time frame: up to 12 months). 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 NCT02086305, which also lists 2 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 22 Aug 2017.