90Second IBD for the Improvement of Self Efficacy and Quality of Life in Inflammatory Bowel Disease Patients
Primary Purpose
IBD, Crohn Disease, Ulcerative Colitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
90Second IBD
Sponsored by
About this trial
This is an interventional other trial for IBD
Eligibility Criteria
Inclusion Criteria: Adult, resident of Canada, diagnosis of IBD, access to a computer or cell phone Exclusion Criteria: N/A
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
90Second IBD
Arm Description
Participants will receive 90SecondIBD weekly at no charge via text message or email linked to a website.
Outcomes
Primary Outcome Measures
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).
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).
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).
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.
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.
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.
Secondary Outcome Measures
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?
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?
Full Information
NCT ID
NCT05686135
First Posted
January 6, 2023
Last Updated
February 22, 2023
Sponsor
Jennifer Jones
Collaborators
90 Second Health, Takeda
1. Study Identification
Unique Protocol Identification Number
NCT05686135
Brief Title
90Second IBD for the Improvement of Self Efficacy and Quality of Life in Inflammatory Bowel Disease Patients
Official Title
90Second IBD for the Improvement of Self Efficacy and Quality of Life in Inflammatory Bowel Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jennifer Jones
Collaborators
90 Second Health, Takeda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBD, Crohn Disease, Ulcerative Colitis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
90Second IBD
Arm Type
Experimental
Arm Description
Participants will receive 90SecondIBD weekly at no charge via text message or email linked to a website.
Intervention Type
Other
Intervention Name(s)
90Second IBD
Intervention Description
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.
Primary Outcome Measure Information:
Title
IBD Specific Quality of life
Description
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).
Time Frame
month 0 (baseline)
Title
IBD Specific Quality of life
Description
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).
Time Frame
month 6
Title
IBD Specific Quality of life
Description
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).
Time Frame
month 12
Title
Self Efficacy
Description
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.
Time Frame
month 0 (baseline)
Title
Self Efficacy
Description
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.
Time Frame
month 6
Title
Self Efficacy
Description
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.
Time Frame
month 12
Secondary Outcome Measure Information:
Title
Participant Satisfaction with 90SecondIBD
Description
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?
Time Frame
month 6
Title
Participant Satisfaction with 90SecondIBD
Description
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?
Time Frame
month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult, resident of Canada, diagnosis of IBD, access to a computer or cell phone
Exclusion Criteria:
N/A
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Jones, MD
Phone
902-473-1499
Email
jljones@dal.ca
12. IPD Sharing Statement
Learn more about this trial
90Second IBD for the Improvement of Self Efficacy and Quality of Life in Inflammatory Bowel Disease Patients
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