Palliative CareESRFNCT02139917
Effects of a Transitional Palliative Care Model on Patients With End-stage Renal Failure
A study testing Transitional community based palliative care in people with Palliative Care and Renal Failure, End-stage, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Primary aim: 1. To compare the effects of customary care and an interventional Home-based Palliative Renal Program (HBPRP) for ESRF patients 2. To compare the effects of customary care and Home-based Palliative Program (HBPP) for ESRF patients Secondary aim: 3. To explore the lived experiences of patients with ESRF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Renal Failure, End-stage
- What is being tested?
- Transitional community based palliative care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteHong Kong
- Study dates
- Aug 2014to Nov 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with chronic kidney disease and diabetic mellitus with Creatinine ≥350 milli mole (uM) or those without diabetic mellitus with Creatinine ≥450 milli mole (uM) who refused renal replacement therapy (RRT);
- Patient not suitable for long term renal replacement therapy (RRT) after assessment by renal team (e.g. multiple co morbidities, poor functional status and social support)
- Identified as ESRF patient eligible for palliative care without prior renal replacement therapy
- Ability to speak Cantonese
- Living within the hospital service area
- Ability to be contacted by phone
Who cannot join
- Discharged to nursing home or other institution
- Inability to communicate
- Cognitive impairment, mini mental stage examination (MMSE) < 20
- Diagnosed with severe psychiatric disorders such as schizophrenia and bipolar disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Transitional Palliative Care Model on Patients With ESRF
Primary aim:
- To compare the effects of customary care and an interventional Home-based Palliative Renal Program (HBPRP) for ESRF patients
- To compare the effects of customary care and Home-based Palliative Program (HBPP) for ESRF patients Secondary aim:
- To explore the lived experiences of patients with ESRF. Hypothesis The transitional renal palliative care model is associated with decreased in unscheduled hospital readmission, reduce length of stay as well as improved quality of life for patients with end-stage renal failure.
Read the detailed description
Objectives
Related to the primary aim:
- Are there differences in healthcare utilization between the ESRF patients in the customary care group and those in the HBPRP group; in the HBPRP group and HBPP group?
- Are there differences in evaluated health outcomes (functional status, symptom intensity, and satisfaction with care) between the customary care group and the HBPRP group ; in the HBPRP group and HBPP group?
- Are there differences in perceived health outcomes (quality of life, caregiver burden) between the customary care group and the HBPRP group; in the HBPRP group and HBPP group? Related to the secondary aim:
- How are the lived experiences compared and contrasted between the customary care group and the HBPRP group; in the HBPRP group and HBPP group?
- Conditions
- Palliative Care, Renal Failure, End-stage
- Being tested
- Transitional community based palliative care
- Keywords
- transitional palliative care, end stage renal failure
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitional community based palliative careBehavioural
Also called Transitional palliative care
transitional palliative care include:-
- telephone follow up for early identification of signs and symptoms
- relief of signs and symptoms encountered
- home visit with spiritual support
| Study group | Role | What they receive |
|---|---|---|
| Transitional Palliative Care | Experimental | Transitional palliative care include:-
* telephone follow up for early identification of signs and symptoms
* home visit for spiritual support Receives: Behavioral: Transitional community based palliative care |
| Customary care | No intervention | Customary care receive care :- * hospital based medical follow up * general nursing assessment and advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare utilization composite - The dates of re-hospitalizations, length of stay, and number of other hospital services used, including clinics and emergency room visits, will be extracted from the hospital administrative systems.
Measured: for 12 months
Secondary outcomes (1)
Evaluated health outcomes composite (functional status, symptom intensity) - The functional status will be measured by the Palliative Performance Scale (PPS )(appendix 6).
The PPS is a clinical tool commonly used in the local settings. The level of physical performance is rated on a scale of 100 (normal) to 0 (death), measured in 10 % decrement levels. The scale has been validated and the inter-rater reliability between doctors and nurses maintained at .85 with strong kappa values of .97 (Myers J, Gardiner K, Harris K et al., 2010).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2017
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Responsible party
- Principal investigator, TAM Mee Ling Bonnie, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139917
- Sponsor's protocol ID
- 23 January 2014
- Acronym
- ESRF
- Status last verified
- Mar 2019
- First submitted
- 5 May 2014
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. 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 ESRF
- ClinicalTrials.gov ID
- NCT02139917
- Acronym / sponsor ID
- ESRF / 23 January 2014
- Conditions
- Palliative Care, Renal Failure, End-stage
- Keywords
- transitional palliative care, end stage renal failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Study start
- Aug 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 16 May 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.
Primary aim:
- To compare the effects of customary care and an interventional Home-based Palliative Renal Program (HBPRP) for ESRF patients
- To compare the effects of customary care and Home-based Palliative Program (HBPP) for ESRF patients Secondary aim:
- To explore the lived experiences of patients with ESRF. Hypothesis The transitional renal palliative care model is associated with decreased in unscheduled hospital readmission, reduce length of stay as well as improved quality of life for patients with end-stage renal failure.
Detailed description
Objectives
Related to the primary aim:
- Are there differences in healthcare utilization between the ESRF patients in the customary care group and those in the HBPRP group; in the HBPRP group and HBPP group?
- Are there differences in evaluated health outcomes (functional status, symptom intensity, and satisfaction with care) between the customary care group and the HBPRP group ; in the HBPRP group and HBPP group?
- Are there differences in perceived health outcomes (quality of life, caregiver burden) between the customary care group and the HBPRP group; in the HBPRP group and HBPP group? Related to the secondary aim:
- How are the lived experiences compared and contrasted between the customary care group and the HBPRP group; in the HBPRP group and HBPP group?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transitional Palliative Care | Experimental | Behavioral: Transitional community based palliative careTransitional palliative care include:- * telephone follow up for early identification of signs and symptoms * home visit for spiritual support |
| Customary care | No intervention | –Customary care receive care :- * hospital based medical follow up * general nursing assessment and advice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with chronic kidney disease and diabetic mellitus with Creatinine ≥350 milli mole (uM) or those without diabetic mellitus with Creatinine ≥450 milli mole (uM) who refused renal replacement therapy (RRT);
- Patient not suitable for long term renal replacement therapy (RRT) after assessment by renal team (e.g. multiple co morbidities, poor functional status and social support)
- Identified as ESRF patient eligible for palliative care without prior renal replacement therapy
- Ability to speak Cantonese
- Living within the hospital service area
Key exclusion criteria (4 listed)
- Discharged to nursing home or other institution
- Inability to communicate
- Cognitive impairment, mini mental stage examination (MMSE) < 20
- Diagnosed with severe psychiatric disorders such as schizophrenia and 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 community based palliative careAlso: Transitional palliative caretransitional palliative care include:- * telephone follow up for early identification of signs and symptoms * relief of signs and symptoms encountered * home visit with spiritual support | Behavioural | Transitional Palliative Care |
Primary outcome
Healthcare utilization composite - The dates of re-hospitalizations, length of stay, and number of other hospital services used, including clinics and emergency room visits, will be extracted from the hospital administrative systems.
Time frame: for 12 months
1 secondary outcome
Evaluated health outcomes composite (functional status, symptom intensity) - The functional status will be measured by the Palliative Performance Scale (PPS )(appendix 6).
Time frame: 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 Mar 2019.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transitional community based palliative care in people with Palliative Care and Renal Failure, End-stage, run by The Hong Kong Polytechnic University 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 6 inclusion and 4 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 Mar 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 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 composite - The dates of re-hospitalizations, length of stay, and number of other hospital services used, including clinics and emergency room visits, will be extracted from the hospital administrative systems. (time frame: for 12 months). 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 22 Mar 2019.