search
Back to results

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
Jennifer Jones
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for IBD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 6, 2023
    Last Updated
    February 22, 2023
    Sponsor
    Jennifer Jones
    Collaborators
    90 Second Health, Takeda
    search

    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

    We'll reach out to this number within 24 hrs