NCT03746626

Brief Summary

Naturalistic pre-post survey design. People with palliative care needs referred to day care in participating hospices will be invited to participate in the study. Those consenting to take part will complete a baseline survey consisting of demographic data on age, gender, reason for admission and whether they self report as religious, spiritual, both, or neither. They also complete he Scottish Patient Reported Outcome Measure (PROM), a five item measure of spiritual outcome/well-being and a free text box. The patient then attends the day care for eight weeks, during which time they may see a chaplain regularly, infrequently, or not at all, entirely dependent on personal preference. The study is designed to be as naturalistic as possible. At the end of the 8 weeks patients complete a follow-up survey containing the same surveys as previous, plus four items about their experiences (or not) with the chaplain. During these eight weeks the chaplain also records the frequency and their interpretation of the depth of the visits with the patient. The primary purpose of the study is to explore the relationship between any change in Scottish PROM scores and the a) frequency and b) chaplain reported depth of the encounters. Secondary objectives are to examine the relationship between the change in PROM scores and the patient's experience of the chaplain interventions. It is hypothesised that the better the chaplain and/or patient self reported experience of the chaplain the greater the improvement in PROM scores. Whether there is any relationship between improvement in PROM scores and whether the patient self describes as religious, spiritual, both or neither will also be analysed.

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

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

November 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 18, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

January 22, 2019

Status Verified

January 1, 2019

Enrollment Period

12 months

First QC Date

November 13, 2018

Last Update Submit

January 18, 2019

Conditions

Keywords

Spiritual carePalliative careChaplainDay care

Outcome Measures

Primary Outcomes (1)

  • Scottish PROM

    The Scottish Patient Reported Outcome Measure is a five-item patient reported outcome measure of spiritual wellbeing. It generates a single score, minimum zero, maximum 20, representing spiritual wellbeing. The measure was validated to measure the impact of chaplain interventions. In a study of over 600 people who had seen a chaplain, scores ranged from 3 to 19, the mean was 12 and standard deviation 2.2. More work is required to calibrate the scale, but early indicators are positive in that scores appear normally distributed and the scale does not have ceiling or floor effects.

    baseline to follow-up = 8 weeks

Secondary Outcomes (1)

  • EQ5D-3L

    baseline to follow-up = 8 weeks

Other Outcomes (2)

  • 'Depth' of chaplain encounter as recorded by chaplain

    every week for 8 weeks

  • Experience of chaplain encounter(s) as recalled by patient

    At week 8 for each participant

Study Arms (3)

Hospice 1

Strathcarron Hospice, Scotland. All consenting patients will either see chaplain or not as many times as per their choice, over eight week stay in day care at the hospice.

Behavioral: Chaplain visit

Hospice 2

Arthur Rank Hospice, England. All consenting patients will either see chaplain or not as many times as per their choice, over eight week stay in day care at the hospice.

Behavioral: Chaplain visit

Hospice 3

All consenting patients will either see chaplain or not as many times as per their choice, over eight week stay in day care at the hospice.

Behavioral: Chaplain visit

Interventions

Chaplain visitBEHAVIORAL

The patients will all see a chaplain routinely during 8-week stay according to their personal preference. The chaplain records the 'depth' and frequency of these encounters.

Hospice 1Hospice 2Hospice 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People referred to day care at participating hospices. All will be invited to participate excepting criteria above

You may qualify if:

  • Patient attending the day unit for minimum 8 weeks
  • Aged 18 and over

You may not qualify if:

  • Patient unable to consent.
  • Under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Strathcarron Hospice

Denny, United Kingdom

RECRUITING

Related Publications (1)

  • Snowden, A., Lobb, E. A., Schmidt, S., Swing, A., McFarlane, C., & Logan, P. (2018). What's on your mind? The only necessary question in spiritual care. Journal of the Study of Spirituality, 8(1), in press. http://doi.org/https://doi.org/10.1080/20440243.2018.1431031

    BACKGROUND

Study Officials

  • Austyn Snowden, PhD

    Edinburgh Napier University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Austyn Snowden, PhD

CONTACT

Anne Vandenhoeck, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Mental Health

Study Record Dates

First Submitted

November 13, 2018

First Posted

November 20, 2018

Study Start

January 18, 2019

Primary Completion

December 31, 2019

Study Completion

March 31, 2020

Last Updated

January 22, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

Anonymised datasets will be made available in line with local data protection policies.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Supporting information available now.
Access Criteria
Please contact Dr Paula Stevenson at p.stevenson@napier.ac.uk
More information

Locations