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

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.

Study Overview

• Status: Withdrawn
• Conditions: Crohn Disease; Ulcerative Colitis; IBD
• Intervention / Treatment: Other: 90Second IBD

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • N.S.
    • Halifax, N.S., Canada, B3H 3A7
      • QEII Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult, resident of Canada, diagnosis of IBD, access to a computer or cell phone

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBD Specific Quality of life	IBD specific quality of life, measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). The SIBDQ comprises a total of 10 questions grouped into four domains: bowel symptoms, emotional health, systemic systems and social function. Each question is scored by a 7-point Likert scale, ranging from 1 to 7, giving an absolute score ranging from 10 (poor health related QoL) to 70 (optimal health related QoL).	month 0 (baseline)
IBD Specific Quality of life	IBD specific quality of life, measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). The SIBDQ comprises a total of 10 questions grouped into four domains: bowel symptoms, emotional health, systemic systems and social function. Each question is scored by a 7-point Likert scale, ranging from 1 to 7, giving an absolute score ranging from 10 (poor health related QoL) to 70 (optimal health related QoL).	month 6
IBD Specific Quality of life	IBD specific quality of life, measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). The SIBDQ comprises a total of 10 questions grouped into four domains: bowel symptoms, emotional health, systemic systems and social function. Each question is scored by a 7-point Likert scale, ranging from 1 to 7, giving an absolute score ranging from 10 (poor health related QoL) to 70 (optimal health related QoL).	month 12
Self Efficacy	Participant self-efficacy rating measured using the 'New General Self Efficacy Scale'. Min score: 1, max score: 8. A higher score indicates a greater self-efficacy.	month 0 (baseline)
Self Efficacy	Participant self-efficacy rating measured using the 'New General Self Efficacy Scale'. Min score: 1, max score: 8. A higher score indicates a greater self-efficacy.	month 6
Self Efficacy	Participant self-efficacy rating measured using the 'New General Self Efficacy Scale'. Min score: 1, max score: 8. A higher score indicates a greater self-efficacy.	month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Satisfaction with 90SecondIBD	Participant Satisfaction will be assessed using 3 questions which are answered on a 1-10 point scale (no short name for the scale, is not a published measurement tool), where 1 is poor/not at all, 10 is excellent/very much : 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?	month 6
Participant Satisfaction with 90SecondIBD	Participant Satisfaction will be assessed using 3 questions which are answered on a 1-10 point scale (no short name for the scale, is not a published measurement tool), where 1 is poor/not at all, 10 is excellent/very much : 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?	month 12

Collaborators and Investigators

• Sponsor: Jennifer Jones
• Collaborators: Takeda; 90 Second Health

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2023
• Primary Completion (Actual): April 24, 2024
• Study Completion (Actual): April 24, 2024

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: January 6, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: November 9, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Crohn Disease; Inflammatory Bowel Diseases
• Other Study ID Numbers: 51239

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No