NCT05391529

Brief Summary

This is a qualitative interview study to understand patients' priorities for different aspects of tests when considering a colonic investigation. Patients currently waiting for colon capsule endoscopy (CCE), and colonoscopy will be invited to take part. Semi-structured interviews will be carried out over the telephone following an interview guide. Recorded interviews will be transcribed and undergo thematic analysis. We will seek to publish the results of this study to inform future research and developments for colonic investigations.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

April 11, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

April 11, 2022

Last Update Submit

May 20, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Completion of a qualitative interview discussing the patients priorities for different aspects of tests when considering a colonic investigation

    We will invite patients to undergo qualitative telephone interviews to establish their priorities for different aspects of tests when considering a colonic investigation.

    Through study completion, an average of 6 months

Secondary Outcomes (1)

  • Completion of a qualitative interview discussing what patients' perceptions of the decision-making process are when choosing between colonic investigations

    Through study completion, an average of 6 months

Study Arms (2)

Colonoscopy

Patients awaiting colonoscopy

Behavioral: Interview

CCE

Patients awaiting colon capsule endoscopy

Behavioral: Interview

Interventions

InterviewBEHAVIORAL

Semi structured patient interview via telephone

CCEColonoscopy

Eligibility Criteria

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

This study will involve recruiting patients on the waiting list for colonoscopy or colon capsule endoscopy from one NHS Scotland Health Board.

You may qualify if:

  • Patients over 18 who are on the waiting list for a colonoscopy or CCE. Only patients who can provide valid consent will be included.
  • English language speaking (translation services are not available for this study).

You may not qualify if:

  • Patients undergoing colonoscopy due to positive bowel screening test or due to surveillance of known colonic pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • MacLeod C, Treweek S, Wilson P, Watson AJM, Robinson S. Patient priorities and decision-making process when choosing between colonic investigation alternatives: a qualitative interview study. BMJ Open Gastroenterol. 2025 Aug 22;12(1):e001602. doi: 10.1136/bmjgast-2024-001602.

MeSH Terms

Conditions

Colonic Diseases

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2022

First Posted

May 26, 2022

Study Start

May 1, 2022

Primary Completion

August 1, 2022

Study Completion

November 1, 2022

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

This is a qualitative interview study so individual data will not be available to share