Effects of a Transitional Palliative Care Model on Patients With End-stage Renal Failure (ESRF)

March 20, 2019 updated by: TAM Mee Ling Bonnie, The Hong Kong Polytechnic University

Effects of a Transitional Palliative Care Model on Patients With ESRF

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. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives

Related to the primary aim:

  1. 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?
  2. 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?

  3. 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:

  4. 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 Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • Hong Kong SAR
      • Hong Kong, Hong Kong SAR, Hong Kong, 852
        • Queen Elizabeth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transitional Palliative Care

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

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
Other Names:
  • Transitional palliative care
No Intervention: Customary care

Customary care receive care :-

  • hospital based medical follow up
  • general nursing assessment and advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
for 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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).
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived outcomes composite (quality of life, caregiver burden, satisfaction with care)
Time Frame: 12 months
Quality of life will be measured by an ESRF-specific quality of life measure. The caregiver burden will be measured by the Zarit Caregiver Burden Scale (ZCBS). Satisfaction with care will be measured by the 15-item questionnaire
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

Hospital Authority, Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

May 5, 2014

First Submitted That Met QC Criteria

May 15, 2014

First Posted (Estimate)

May 16, 2014

Study Record Updates

Last Update Posted (Actual)

March 22, 2019

Last Update Submitted That Met QC Criteria

March 20, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23 January 2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Palliative Care

Clinical Trials on Transitional community based palliative care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe