NCT02139917

Brief Summary

Primary aim:

  1. 1.To compare the effects of customary care and an interventional Home-based Palliative Renal Program (HBPRP) for ESRF patients
  2. 2.To compare the effects of customary care and Home-based Palliative Program (HBPP) for ESRF patients
  3. 3.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

March 22, 2019

Status Verified

March 1, 2019

Enrollment Period

3.1 years

First QC Date

May 5, 2014

Last Update Submit

March 20, 2019

Conditions

Keywords

transitional palliative careend stage renal failure

Outcome Measures

Primary Outcomes (1)

  • 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.

    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).

    12 months

Other Outcomes (1)

  • Perceived outcomes composite (quality of life, caregiver burden, satisfaction with care)

    12 months

Study Arms (2)

Transitional Palliative Care

EXPERIMENTAL

Transitional palliative care include:- * telephone follow up for early identification of signs and symptoms * home visit for spiritual support

Behavioral: Transitional community based palliative care

Customary care

NO INTERVENTION

Customary care receive care :- * hospital based medical follow up * general nursing assessment and advice

Interventions

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

Also known as: Transitional palliative care
Transitional Palliative Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth Hospital

Hong Kong, Hong Kong SAR, 852, Hong Kong

Location

MeSH Terms

Conditions

Kidney Failure, ChronicRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate

Study Record Dates

First Submitted

May 5, 2014

First Posted

May 16, 2014

Study Start

August 1, 2014

Primary Completion

September 1, 2017

Study Completion

November 1, 2018

Last Updated

March 22, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations