NCT04900103

Brief Summary

How can offer support to patients and families through a volunteer caring program based on new technologies? The aim of this study is to implement and evaluate a volunteer training programme in the use of new technologies: ITV-Pal Programme to support patients facing a life-threatening illness and their families. It will created two groups of volunteers, one group will follow the CUDECA standard training program, the other will follow the proposed intervention, ITV-Pal programme. Volunteers will be allocated randomly to each group. Second stage will consist in the implementation of the direct support to patients and families through the volunteers. The expectation is that ITV-Pal volunteers trained will be able to increase general welfare of patients and families they care for. To test it, the quality of life of patients, families and volunteers, the quality of the dying process, and identify how new technology supports volunteer end of life care will be measure.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

December 10, 2021

Status Verified

November 1, 2021

Enrollment Period

11 months

First QC Date

April 5, 2021

Last Update Submit

November 29, 2021

Conditions

Palliative Care

Keywords

Palliative CareVolunteeringNew technologies

Outcome Measures

Primary Outcomes (2)

  • Distress thermometer

    Distress is an unpleasant experience of a mental, physical, social, or spiritual nature. It can affect the way you think, feel, or act. Distress may make it harder to cope with having cancer, its symptoms, or its treatment. 0 no distress 10 extreme distress

    Through study completion, an average of 3 months

  • ICECAP-SCM

    The ICECAP Supportive Care Measure (ICECAP-SCM) has been developed as a tool for use in economic evaluation conducted in an end of life setting

    Through study completion, an average of 15 days

Secondary Outcomes (6)

  • EuroQoL 5D-5L

    Baseline, 15 and 30 days after inclusion.

  • Satisfaction Volunteer Programme

    Through study completion, an average of 12 months

  • Service Improvement Metrics: fidelity

    Through study completion, an average of 12 months

  • Service Improvement Metrics: dose

    Through study completion, an average of 12 months

  • Service Improvement Metrics: reach

    Through study completion, an average of 12 months

  • +1 more secondary outcomes

Other Outcomes (5)

  • PHTech questionnaire

    Through study completion, an average of 3 months

  • Volunteer Motivation (VFI)

    Baseline

  • Age

    Baseline

  • +2 more other outcomes

Study Arms (2)

Tech-volunteer

EXPERIMENTAL

A complex intervention with two phases is proposed. * First phase: volunteers new technologies training (tech-volunteering). Volunteers will be trained in the use of NT and their interconnectivity as tools to support their volunteer work. This training will be integrated into the PC volunteer training programme. * Second phase: using the NT with patients and relatives.

Other: ITV-Pal

Usual volunteer

NO INTERVENTION

the control group will receive standard volunteer service.

Interventions

ITV-PalOTHER

Use of new technologies for volunteering

Tech-volunteer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients/relatives:
  • Over 18 years; PC patients and relatives eligible for volunteer support according to the PC team assessment.
  • Acceptance to participate in the study by signing the Informed Consent.
  • PC Volunteers:
  • \- Acceptance to participate in the study by signing the Informed Consent.

You may not qualify if:

  • \- No acceptance to participate in the study by signing the Informed Consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación CUDECA

Benalmádena, Málaga, 29631, Spain

RECRUITING

Related Publications (1)

  • Barnestein-Fonseca P, Vibora-Martin E, Ruiz-Torreras I, Chapinal-Bascon H, Martin-Rosello ML, Gomez-Garcia R. ITV-Pal programme: protocol of evaluation of the implementation of tech-volunteer programme in palliative care services. BMJ Open. 2023 Aug 24;13(8):e065222. doi: 10.1136/bmjopen-2022-065222.

    PMID: 37620277DERIVED

Central Study Contacts

Pilar Barnestein-Fonseca, PhD

CONTACT

+34657201115pilarbarnestein@cudeca.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2021

First Posted

May 25, 2021

Study Start

November 1, 2021

Primary Completion

September 30, 2022

Study Completion

December 31, 2022

Last Updated

December 10, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)