Intervention in Spirituality at the End of Life. The Kibo Protocol
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2016
Typical duration for not_applicable
1 active site
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
Study Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2019
CompletedFirst Submitted
Initial submission to the registry
June 5, 2019
CompletedFirst Posted
Study publicly available on registry
June 21, 2019
CompletedJune 27, 2019
June 1, 2019
2.8 years
June 5, 2019
June 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Baseline up to 4 weeks
Secondary Outcomes (2)
Change in resilience (PRE and POST measures)
Baseline up to 4 weeks
Change in demoralization (PRE and POST measures)
Baseline up to 4 weeks
Study Arms (2)
Control group
NO INTERVENTIONGroup of participants that received usual psychological attention.
Experimental group
EXPERIMENTALGroup of participants that received usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention).
Interventions
The kibo protocol is a therapeutic interview designed to address the spiritual needs of patients at the end of life.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- a) Estimated time of survival: Patients with a life expectancy of two weeks or less will not be intervened.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitat de València
Valencia, 46010, Spain
Related Publications (1)
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.
PMID: 32973614DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Pilar Barreto Martin, PhD
Universitat de València
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Profesora Titular
Study Record Dates
First Submitted
June 5, 2019
First Posted
June 21, 2019
Study Start
March 1, 2016
Primary Completion
December 31, 2018
Study Completion
March 31, 2019
Last Updated
June 27, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share