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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02139917
Recruitment Status : Completed
First Posted : May 16, 2014
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
Hospital Authority, Hong Kong
Information provided by (Responsible Party):
TAM Mee Ling Bonnie, The Hong Kong Polytechnic University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Palliative Care Renal Failure, End-stage Behavioral: Transitional community based palliative care Not Applicable

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?

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of a Transitional Palliative Care Model on Patients With ESRF
Study Start Date : August 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


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 Name: Transitional palliative care

No Intervention: Customary care

Customary care receive care :-

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



Primary Outcome Measures :
  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. [ Time Frame: for 12 months ]

Secondary Outcome Measures :
  1. 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).


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139917


Locations
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Hong Kong
Queen Elizabeth Hospital
Hong Kong, Hong Kong SAR, Hong Kong, 852
Sponsors and Collaborators
The Hong Kong Polytechnic University
Hospital Authority, Hong Kong
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Responsible Party: TAM Mee Ling Bonnie, Clinical Associate, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT02139917    
Other Study ID Numbers: 23 January 2014
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by TAM Mee Ling Bonnie, The Hong Kong Polytechnic University:
transitional palliative care
end stage renal failure
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic