90Second IBD for the Improvement of Self Efficacy and Quality of Life in Inflammatory Bowel Disease Patients

Sponsor
Jennifer Jones (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05686135
Collaborator
90 Second Health (Other), Takeda (Industry)
500
1
12

Study Details

Study Description

Brief Summary

Patients with Inflammatory Bowel Disease (IBD) have poorer quality of life than healthy people. Despite the high prevalence of psychological issues and its profound influence on quality of life, most IBD patients have limited access to mental health support. As well, many may decline support if it is offered because mental health is often not thought of as part of IBD care. Patients may be able to access cognitive behavioural therapy (CBT) through a psychologist, however this intervention is costly and requires considerable commitment on the part of person with IBD. There is a need for new methods of reaching IBD patients to provide information on their psychological needs, and normalize the psychological effects of IBD. These new methods should integrate medical issues with psychosocial issues while being effective, scalable, and low cost to the health care system. 90SecondIBD is a novel way of delivering health information about IBD using Persuasive Design technology embedded in a planned behavior model. This project will investigate the effect of the intervention "90SecondIBD", a weekly online health letter, on IBD patients' quality of life and self efficacy. Regression modelling will be performed to explore the ability of clinical and demographic factors to predict quality of life and self efficacy scores following receipt of 90SecondIBD educational health letters weekly for 6 months and 12 months.

Condition or Disease Intervention/Treatment Phase
  • Other: 90Second IBD
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
90Second IBD for the Improvement of Self Efficacy and Quality of Life in Inflammatory Bowel Disease Patients
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 90Second IBD

Participants will receive 90SecondIBD weekly at no charge via text message or email linked to a website.

Other: 90Second IBD
Patients will receive 90SecondIBD weekly at no charge via text message or email linked to a website.Each 90SecondIBD letter has an attractive photo, 250 words of targeted information on a specific topic and 3 specific action suggestions on the first page. The second page is a seven-item quiz on attitudes and behavior on the designated topic. The reader gets immediate feedback and advice. The third page is a personal story of someone with IBD about this topic. Finally, there is an evaluation of the specific 90SecondIBD issue and an opportunity to recommend topics.

Outcome Measures

Primary Outcome Measures

  1. IBD Specific Quality of life [month 0 (baseline), month 6, month 12]

    IBD specific quality of life, measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

  2. Self Efficacy [month 0 (baseline), month 6, month 12]

    Self efficacy measured using the New General Self Efficacy Scale

Secondary Outcome Measures

  1. Participant Satisfaction with 90SecondIBD [month 6, month 12]

    Participant Satisfaction will be assessed using 3 questions which are answered on a 1-10 point scale: Please rate the overall value of the 90SecondIBD , Would you recommend 90SecondIBD to a friend or family member with IBD, How much did 90SecondIBD help with your management of the psychological aspects of IBD?

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult, resident of Canada, diagnosis of IBD, access to a computer or cell phone
Exclusion Criteria:
  • N/A

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Jennifer Jones
  • 90 Second Health
  • Takeda

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jennifer Jones, Gastroenterologist, Nova Scotia Health Authority
ClinicalTrials.gov Identifier:
NCT05686135
Other Study ID Numbers:
  • 51239
First Posted:
Jan 17, 2023
Last Update Posted:
Jan 17, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 17, 2023