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

Primary Purpose

Palliative Care

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Therapeutic interview: kibo protocol
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Palliative Care focused on measuring Spirituality, Intervention Study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universitat de València

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Experimental group

Arm Description

Group of participants that received usual psychological attention.

Group of participants that received usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention).

Outcomes

Primary Outcome Measures

Change in the dimension of spirituality (PRE and POST measures)
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

Change in resilience (PRE and POST measures)
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).
Change in demoralization (PRE and POST measures)
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).

Full Information

First Posted
June 5, 2019
Last Updated
June 25, 2019
Sponsor
University of Valencia
Collaborators
Sociedad Española de Cuidados Paliativos SECPAL
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1. Study Identification

Unique Protocol Identification Number
NCT03995095
Brief Title
Intervention in Spirituality at the End of Life. The Kibo Protocol
Official Title
Intervention in Spirituality at the End of Life. The Kibo Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
Collaborators
Sociedad Española de Cuidados Paliativos SECPAL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palliative Care
Keywords
Spirituality, Intervention Study

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Group of participants that received usual psychological attention.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Group of participants that received usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention).
Intervention Type
Other
Intervention Name(s)
Therapeutic interview: kibo protocol
Intervention Description
The kibo protocol is a therapeutic interview designed to address the spiritual needs of patients at the end of life.
Primary Outcome Measure Information:
Title
Change in the dimension of spirituality (PRE and POST measures)
Description
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).
Time Frame
Baseline up to 4 weeks
Secondary Outcome Measure Information:
Title
Change in resilience (PRE and POST measures)
Description
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).
Time Frame
Baseline up to 4 weeks
Title
Change in demoralization (PRE and POST measures)
Description
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).
Time Frame
Baseline up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: To be 18 or more years of age. Being in advanced or terminal disease phase (following World Health Organization criteria). To have preserved cognitive capacity. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pilar Barreto Martin, PhD
Organizational Affiliation
Universitat de València
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitat de València
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32973614
Citation
Soto-Rubio A, Perez-Marin M, Rudilla D, Galiana L, Oliver A, Fombuena M, Barreto P. Responding to the Spiritual Needs of Palliative Care Patients: A Randomized Controlled Trial to Test the Effectiveness of the Kibo Therapeutic Interview. Front Psychol. 2020 Aug 21;11:1979. doi: 10.3389/fpsyg.2020.01979. eCollection 2020.
Results Reference
derived

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

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