IBDNCT05686135
90Second IBD for the Improvement of Self Efficacy and Quality of Life in Inflammatory Bowel Disease Patients
A study testing 90Second IBD in people with IBD and Crohn Disease, run by Jennifer Jones at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD, Crohn Disease, Ulcerative Colitis
- What is being tested?
- 90Second IBD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 7 Jun 2023to 24 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, resident of Canada, diagnosis of IBD, access to a computer or cell phone
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- IBD, Crohn Disease, Ulcerative Colitis
- Being tested
- 90Second IBD
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
90Second IBDOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 90Second IBD | Experimental | Participants will receive 90SecondIBD weekly at no charge via text message or email linked to a website. Receives: Other: 90Second IBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: month 12
Secondary outcomes (2)
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?
Measured: 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?
Measured: month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start7 Jun 2023
- Primary completion24 Apr 2024
- Study completion24 Apr 2024
Why it stopped: Company could not update IT infrastructure to support the project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Jones
- Sponsor type
- University, hospital or other
- Collaborators
- 90 Second Health, Takeda
- Responsible party
- Sponsor-investigator, Jennifer Jones, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686135
- Sponsor's protocol ID
- 51239
- Status last verified
- Nov 2024
- First submitted
- 6 Jan 2023
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 90Second IBD for the Improvement of Self Efficacy and Quality of Life in Inflammatory Bowel Disease Patients
- ClinicalTrials.gov ID
- NCT05686135
- Acronym / sponsor ID
- 51239
- Conditions
- IBD, Crohn Disease, Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company could not update IT infrastructure to support the project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jennifer JonesUniversity, hospital or other
- Collaborators
- 90 Second Health, Takeda
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 90Second IBD | Experimental | Other: 90Second IBDParticipants will receive 90SecondIBD weekly at no charge via text message or email linked to a website. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult, resident of Canada, diagnosis of IBD, access to a computer or cell phone
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 90Second IBDPatients 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. | Other | 90Second IBD |
Primary outcome
IBD Specific Quality of life
Time frame: month 0 (baseline)
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
Time frame: month 6
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
Time frame: month 12
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
Time frame: month 0 (baseline)
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
Time frame: month 6
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
Time frame: month 12
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.
2 secondary outcomes
Participant Satisfaction with 90SecondIBD
Time frame: month 6
Participant Satisfaction with 90SecondIBD
Time frame: month 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 90Second IBD in people with IBD and Crohn Disease, run by Jennifer Jones at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBD Specific Quality of life (time frame: month 0 (baseline)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.