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Intervention in Spirituality at the End of Life. The Kibo Protocol

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: NCT03995095
Recruitment Status : Completed
First Posted : June 21, 2019
Last Update Posted : June 27, 2019
Sponsor:
Collaborator:
Sociedad Española de Cuidados Paliativos SECPAL
Information provided by (Responsible Party):
M. Antonia Pérez-Marín, University of Valencia

Brief Summary:

This work aims to study the benefits that the therapeutic interview Kibo in palliative care patients can have for spirituality.

A parallel randomized controlled trial of two groups was performed. Information was collected on 60 palliative care patients during the moments before and after the intervention.


Condition or disease Intervention/treatment Phase
Palliative Care Other: Therapeutic interview: kibo protocol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Intervention in Spirituality at the End of Life. The Kibo Protocol
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
No Intervention: Control group
Group of participants that received usual psychological attention.
Experimental: Experimental group
Group of participants that received usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention).
Other: Therapeutic interview: kibo protocol
The kibo protocol is a therapeutic interview designed to address the spiritual needs of patients at the end of life.




Primary Outcome Measures :
  1. Change in the dimension of spirituality (PRE and POST measures) [ Time Frame: Baseline up to 4 weeks ]

    This variable was assessed with the Spirituality questionnaire from the Spanish Society of Palliative Care (SECPAL). This questionnaire contains 8 items, and it provides scores from 0 to 32, where higher values represent a better outcome.

    In order to observe the change in the dimension of spirituality, it was measured at in two time points:

    First measurement: PRE. Once the participant had signed the informed consent, the initial score for this outcome was assessed.

    Second measurement: POST. Up to 4 weeks after the first measurement, the second measurement of the same variable was carried out.

    Between first and second measurement, the control group received the usual psychological attention, whereas the intervention group received usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention).



Secondary Outcome Measures :
  1. Change in resilience (PRE and POST measures) [ Time Frame: Baseline up to 4 weeks ]

    This variable was assessed with the Brief Resilient Coping Scale (BRCS). This scale contains 4 items, and it provides scores from 4 to 20, where higher values represent a better outcome.

    In order to observe the change in the dimension of resilience, it was measured at in two time points:

    First measurement: PRE. Once the participant had signed the informed consent, the initial score for this outcome was assessed.

    Second measurement: POST. Up to 4 weeks after the first measurement, the second measurement of the same variable was carried out.

    Between first and second measurement, the control group received the usual psychological attention, whereas the intervention group received usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention).


  2. Change in demoralization (PRE and POST measures) [ Time Frame: Baseline up to 4 weeks ]

    This variable was assessed with the Short Demoralization Scale (SDS). This scale contains 5 items, and it provides scores from 0 to 20, where lower values represent a better outcome.

    In order to observe the change in the dimension of demoralization, it was measured at in two time points:

    First measurement: PRE. Once the participant had signed the informed consent, the initial score for this outcome was assessed.

    Second measurement: POST. Up to 4 weeks after the first measurement, the second measurement of the same variable was carried out.

    Between first and second measurement, the control group received the usual psychological attention, whereas the intervention group received usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention).




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:

  1. To be 18 or more years of age.
  2. Being in advanced or terminal disease phase (following World Health Organization criteria).
  3. To have preserved cognitive capacity.
  4. To have signed the informed consent.

Exclusion Criteria:

a) Estimated time of survival: Patients with a life expectancy of two weeks or less will not be intervened.


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): NCT03995095


Locations
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Spain
Universitat de València
Valencia, Spain, 46010
Sponsors and Collaborators
University of Valencia
Sociedad Española de Cuidados Paliativos SECPAL
Investigators
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Principal Investigator: Pilar Barreto Martin, PhD Universitat de València
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Responsible Party: M. Antonia Pérez-Marín, Profesora Titular, University of Valencia
ClinicalTrials.gov Identifier: NCT03995095    
Other Study ID Numbers: H1447334931417
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M. Antonia Pérez-Marín, University of Valencia:
Spirituality
Intervention Study