Inflammatory Bowel DiseaseIMPACT-IBDNCT02085083
Improving OutcoMes in the Pediatric to Adult Care Transition in Inflammatory Bowel Disease
A study testing Telephone and email correspondence with an Inflammatory Bowel Disease Nurse and Minimal Intervention Arm in people with Inflammatory Bowel Disease and Crohn Disease, run by Mount Sinai Hospital, Canada at 3 sites in Canada.
Trial summary
The transition from pediatric to adult IBD care can be stressful and wrought with challenges including access to care and establishment of new physician-patient relationships. There a few studies which characterize patterns of healthcare utilization during this critical period and its impact on outcomes. Read more about this study
- Who is it for?
- Ages 16 to 18 years
- Conditions the study is for
- Inflammatory Bowel Disease, Crohn Disease, Colitis, Ulcerative
- What is being tested?
- Telephone and email correspondence with an Inflammatory Bowel Disease Nurse and Minimal Intervention Arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesCanada
- Study dates
- Jul 2014to Dec 2017
- 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 16 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- This study comprises adolescent subjects recruited from the IBD clinics of the Hospital for Sick Children and McMaster Children's Hospital who meet the following inclusion criteria: (1) diagnosis of IBD; (2) at least age 16 years or older; (3) planning to undergo transition of care and will be followed by a gastroenterologist in either an academic center or the community; (4) have access to email or other means of telecommunication.
Who cannot join
- We will exclude any subjects who will not be residing in Canada or who will not be enrolled in the Ontario Health Insurance Plan (OHIP) after exiting pediatric care. Registration with OHIP, even if residing in a different province, is required for the monitoring of health utilization.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
McMaster University Medical Center
Hamilton, Ontario, L8N 3Z5
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
The Hospital for Sick Children (SickKids)
Toronto, Ontario, M5G 1X8
About this study
The transition from pediatric to adult IBD care can be stressful and wrought with challenges including access to care and establishment of new physician-patient relationships. There a few studies which characterize patterns of healthcare utilization during this critical period and its impact on outcomes. We hypothesize that uninterrupted healthcare utilization in academic centers and optimized communication with patients during the pediatric-adult transition period is associated with lower hospitalizations and surgery. This hypothesis will be addressed by a randomized clinical trial to determine the impact of monthly regular telephone contact with an IBD Registered Nurse versus standard of care during the pediatric-adult transition period. Outcomes will include healthcare utilization, health-related quality of life, patient satisfaction, and treatment adherence over 12 months of follow-up. Randomization and analyses will be stratified by whether subjects were transferred to adult care in an academic center or in a community practice. We hope that this research will facilitate optimal delivery of healthcare during the pediatric-adult transition.
Read the detailed description
Rationale: The years marking the transition from pediatric-to-adult transition can be particularly difficult and transitioning patients with IBD may be at increased risk for loss to follow-up. As patient advocates, we need an intervention that would enable continuity of care especially among young adults who may face obstacles in accessing regular office visits. An intervention such as regular email contact with an IBD nurse may especially benefit those who are transitioning to community gastroenterology practices or to geographic regions where there is difficulty in accessing gastroenterology care. The lack of continuity of care may lead to delayed treatment which may be associated with poor clinical outcomes.
Research Question and Hypothesis: Our primary question is whether regular email contact with an IBD nurse can improve health outcomes. We hypothesize that such interaction, through augmented continuity of care will lead to increased patient satisfaction, increased medical adherence, improved transition readiness, decreased disease activity, and consequently decreased costly visits to the emergency department and hospitalizations.
Study Design: Multi-center randomized controlled clinical trial
Study population and inclusion/exclusion criteria: This study comprise adolescent subjects recruited from the IBD clinics of the Hospital for Sick Children, McMaster Children's Hospital or Children's Hospital of Eastern Ontario who meet the following inclusion criteria: (1) diagnosis of IBD; (2) at least age 16 years or older; (3) planning to undergo transition of care and will be followed by a gastroenterologist in either an academic center or the community; (4) have access to email or other means of telecommunication. We will exclude any subjects who will not be residing in Canada or who will not be enrolled in the Ontario Health Insurance Plan after exiting pediatric care. Registration with OHIP, even if residing in a different province, is required for monitoring of health utilization.
Health Implications: Our study may demonstrate cost-savings from decreased non-routine healthcare utilization coupled with improvement in health outcomes that may support the more widespread use of routine email-based interactions with IBD allied health providers in the pediatric-adult transition period.
- Being tested
- Telephone and email correspondence with an Inflammatory Bowel Disease Nurse, Minimal Intervention Arm
- Keywords
- Inflammatory Bowel Disease, Transition, Adolescent, Chronic Disease, Colitis, Ulcerative
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone and email correspondence with an Inflammatory Bowel Disease NurseBehavioural
The IBD pediatric-adult transition nurse will send an email each month containing:
Brief Questionnaire: A link to a secured website will be provided where participants will respond to a questionnaire.
Direct Nurse Contact: Telephone and email correspondence with an Inflammatory Bowel Disease Nurse
Educational module: Every other month, we will include in the email another link to an optional educational module that will be part of a curriculum to facilitate transition readiness.
MyHealth Passport
Study Questionnaire: A personalized link to a more comprehensive study questionnaire similar to the baseline questionnaire will be emailed in the 6th and 12th (final) email.
Minimal Intervention ArmBehavioural
Patients randomized to the control group will have receive email based questionnaires and information relating to the MyHealth Passport application. This intervention is not expected to significantly improve outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Regular telephone and email access to an IBD Nurse | Experimental | The IBD pediatric-adult transition nurse will send an email to each individual randomized to the intervention arm each month. The email will include the following: Brief Questionnaire;The Option For Direct Nurse Contact; Educational modules; MyHealth Passport and a Comprehensive Study Questionnaire. Receives: Behavioral: Telephone and email correspondence with an Inflammatory Bowel Disease Nurse |
| Minimal Intervention | Active comparator | The IBD pediatric-adult transition nurse will send an email to each individual randomized to the control arm every 3 months. The email will include the following: MyHealth Passport and Study Questionnaire. This intervention is not expected to significantly improve outcomes. Receives: Behavioral: Minimal Intervention Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Satisfaction
A comprehensive study questionnaire containing the CACHE questionnaire will be administered to assess patient satisfaction.
Reference: Casellas F, Ginard D, Vera I, Torrejón A. Development and testing of a new instrument to measure patient satisfaction with health care in inflammatory bowel disease: the CACHE questionnaire. Inflamm Bowel Dis. 2013 Mar;19(3):559-68.
Measured: Patient satisfaction will be assessed prior to transfer of care (within 3 months from the time of randomization) and again post-transfer of care (within 12 months from the time of randomization).
Change in Medication Adherence
Medication adherence will be assessed with a comprehensive study questionnaire containing the Morisky questionnaire.
Reference: Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care 1986;24:67-74.
Measured: Medication adherence will be assessed prior to transfer of care (within 3 months from the time of randomization) and again post-transfer of care (within 12 months from the time of randomization).
Change in Non-Routine Healthcare Utilization
IBD related clinic visits, admissions to hospital, emergency department visits, endoscopy and operative procedures, imaging procedures will all be recorded via telephone interview with the patient and also via linkage to the Institute of Clinical and Evaluative Sciences Databases which record health claims by Ontario residents . The date of transfer of care to an adult gastroenterologist will be recorded as well as any continuing appointments with a pediatric gastroenterologist beyond the transfer date.
Measured: Non-routine healthcare utilization will be assessed retrospectively for 12 months prior to transfer of care and compared to 12 months post-transfer of care.
Change in Transition Readiness
The Transition Readiness Assessment Questionnaire will be administered.
Reference: Sawicki GS, Lukens-Bull K, Yin X, Demars N, Huang IC, Livingood W, Reiss J, Wood D. Measuring the transition readiness of youth with special healthcare needs: validation of the TRAQ--Transition Readiness Assessment Questionnaire. J Pediatr Psychol. 2011 Mar;36(2):160-71.
Measured: Transition readiness will be assessed prior to transfer of care (within 3 months from the time of randomization) and again post-transfer of care (within 12 months from the time of randomization).
Secondary outcomes (3)
Change in Quality of Life
Health Related Quality of Life will be monitored by the Inflammatory Bowel Disease Questionnaire (IBDQ) validated in IBD patients.
Reference: Inflammatory Bowel Disease Questionnaire - Guyatt G, Mitchell A, Irvine EJ, Singer J, Williams N, Goodacre R, Tompkins C. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology. 1989;96:804-10.
Measured: Quality of life will be assessed prior to transfer of care (within 3 months from the time of randomization) and again post-transfer of care (within 12 months from the time of randomization).
Change in Disease Activity
Disease activity will be monitored using the Harvey Bradshaw Index (HBI) for Crohn's Disease related disease activity and the Ulcerative Colitis Disease Activity Index (UCDAI) for UC-related disease activity
References:
Harvey RF, Bradshaw JM. A simple index of Crohn's-disease activity. Lancet. 1980;315(8167):514.
Sutherland LR, Martin F, Greer S, Robinson M, Greenberger N, Saibil F, Martin T, Sparr J, Prokipchuk E, Borgen L: 5-Aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis. Gastroenterology 1987, 92:1894-8.
Measured: Disease activity will be assessed prior to transfer of care (within 3 months from the time of randomization) and again post-transfer of care (within 12 months from the time of randomization).
Change in Knowledge of Disease
The Crohn's and Colitis Knowledge Questionnaire will be used to assess IBD specific knowledge.
Reference: Eaden JA, Abram K, Mayberry JF. The Crohn's and colitis knowledge score: a test for measuring patient knowledge in inflammatory bowel disease. Am J Gastroenterol; 1999: 94(12):3560 - 3566.
Measured: Knowledge of disease will be assessed prior to transfer of care (within 3 months from the time of randomization) and again post-transfer of care (within 12 months from the time of randomization).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Responsible party
- Sponsor
- Investigators
- Geoffrey Nguyen, MD, PhD, Principal investigator, Mount Sinai Hospital, CanadaAnne Griffiths, MD, Principal investigator, The Hospital For Sick Children, Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085083
- Sponsor's protocol ID
- IMPACT-IBD
- Acronym
- IMPACT-IBD
- Status last verified
- Apr 2018
- First submitted
- 23 Dec 2013
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bollegala N, Brill H, Marshall JK. Resource utilization during pediatric to adult transfer of care in IBD. J Crohns Colitis. 2013 Mar;7(2):e55-60. doi: 10.1016/j.crohns.2012.05.010. Epub 2012 Jun 5.
PubMed 22677118Pinzon JL, Jacobson K, Reiss J. Say goodbye and say hello: the transition from pediatric to adult gastroenterology. Can J Gastroenterol. 2004 Dec;18(12):735-42. doi: 10.1155/2004/474232.
PubMed 15605138Baldassano R, Ferry G, Griffiths A, Mack D, Markowitz J, Winter H. Transition of the patient with inflammatory bowel disease from pediatric to adult care: recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr. 2002 Mar;34(3):245-8. doi: 10.1097/00005176-200203000-00001. No abstract available.
PubMed 11964946Scal P, Evans T, Blozis S, Okinow N, Blum R. Trends in transition from pediatric to adult health care services for young adults with chronic conditions. J Adolesc Health. 1999 Apr;24(4):259-64. doi: 10.1016/s1054-139x(98)00127-x.
PubMed 10227345Dabadie A, Troadec F, Heresbach D, Siproudhis L, Pagenault M, Bretagne JF. Transition of patients with inflammatory bowel disease from pediatric to adult care. Gastroenterol Clin Biol. 2008 May;32(5 Pt 1):451-9. doi: 10.1016/j.gcb.2008.01.044. Epub 2008 May 8.
PubMed 18472377Hait EJ, Barendse RM, Arnold JH, Valim C, Sands BE, Korzenik JR, Fishman LN. Transition of adolescents with inflammatory bowel disease from pediatric to adult care: a survey of adult gastroenterologists. J Pediatr Gastroenterol Nutr. 2009 Jan;48(1):61-5. doi: 10.1097/MPG.0b013e31816d71d8.
PubMed 19172125Greenley RN, Stephens M, Doughty A, Raboin T, Kugathasan S. Barriers to adherence among adolescents with inflammatory bowel disease. Inflamm Bowel Dis. 2010 Jan;16(1):36-41. doi: 10.1002/ibd.20988.
PubMed 19434722
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving OutcoMes in the Pediatric to Adult Care Transition in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02085083
- Acronym / sponsor ID
- IMPACT-IBD / IMPACT-IBD
- Keywords
- Inflammatory Bowel Disease, Transition, Adolescent, Chronic Disease, Colitis, Ulcerative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Study start
- Jul 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 Mar 2014 (estimated)
- 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.
The transition from pediatric to adult IBD care can be stressful and wrought with challenges including access to care and establishment of new physician-patient relationships. There a few studies which characterize patterns of healthcare utilization during this critical period and its impact on outcomes. We hypothesize that uninterrupted healthcare utilization in academic centers and optimized communication with patients during the pediatric-adult transition period is associated with lower hospitalizations and surgery. This hypothesis will be addressed by a randomized clinical trial to determine the impact of monthly regular telephone contact with an IBD Registered Nurse versus standard of care during the pediatric-adult transition period. Outcomes will include healthcare utilization, health-related quality of life, patient satisfaction, and treatment adherence over 12 months of follow-up. Randomization and analyses will be stratified by whether subjects were transferred to adult care in an academic center or in a community practice. We hope that this research will facilitate optimal delivery of healthcare during the pediatric-adult transition.
Detailed description
Rationale: The years marking the transition from pediatric-to-adult transition can be particularly difficult and transitioning patients with IBD may be at increased risk for loss to follow-up. As patient advocates, we need an intervention that would enable continuity of care especially among young adults who may face obstacles in accessing regular office visits. An intervention such as regular email contact with an IBD nurse may especially benefit those who are transitioning to community gastroenterology practices or to geographic regions where there is difficulty in accessing gastroenterology care. The lack of continuity of care may lead to delayed treatment which may be associated with poor clinical outcomes.
Research Question and Hypothesis: Our primary question is whether regular email contact with an IBD nurse can improve health outcomes. We hypothesize that such interaction, through augmented continuity of care will lead to increased patient satisfaction, increased medical adherence, improved transition readiness, decreased disease activity, and consequently decreased costly visits to the emergency department and hospitalizations.
Study Design: Multi-center randomized controlled clinical trial
Study population and inclusion/exclusion criteria: This study comprise adolescent subjects recruited from the IBD clinics of the Hospital for Sick Children, McMaster Children's Hospital or Children's Hospital of Eastern Ontario who meet the following inclusion criteria: (1) diagnosis of IBD; (2) at least age 16 years or older; (3) planning to undergo transition of care and will be followed by a gastroenterologist in either an academic center or the community; (4) have access to email or other means of telecommunication. We will exclude any subjects who will not be residing in Canada or who will not be enrolled in the Ontario Health Insurance Plan after exiting pediatric care. Registration with OHIP, even if residing in a different province, is required for monitoring of health utilization.
Health Implications: Our study may demonstrate cost-savings from decreased non-routine healthcare utilization coupled with improvement in health outcomes that may support the more widespread use of routine email-based interactions with IBD allied health providers in the pediatric-adult transition period.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular telephone and email access to an IBD Nurse | Experimental | Behavioral: Telephone and email correspondence with an Inflammatory Bowel Disease NurseThe IBD pediatric-adult transition nurse will send an email to each individual randomized to the intervention arm each month. The email will include the following: Brief Questionnaire;The Option For Direct Nurse Contact; Educational modules; MyHealth Passport and a Comprehensive Study Questionnaire. |
| Minimal Intervention | Active comparator | Behavioral: Minimal Intervention ArmThe IBD pediatric-adult transition nurse will send an email to each individual randomized to the control arm every 3 months. The email will include the following: MyHealth Passport and Study Questionnaire. This intervention is not expected to significantly improve outcomes. |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- This study comprises adolescent subjects recruited from the IBD clinics of the Hospital for Sick Children and McMaster Children's Hospital who meet the following inclusion criteria: (1) diagnosis of IBD; (2) at least age 16 years or older; (3) planning to undergo transition of care and will be followed by a gastroenterologist in either an academic center or the community; (4) have access to email or other means of telecommunication.
Key exclusion criteria (1 listed)
- We will exclude any subjects who will not be residing in Canada or who will not be enrolled in the Ontario Health Insurance Plan (OHIP) after exiting pediatric care. Registration with OHIP, even if residing in a different province, is required for the monitoring of health utilization.
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 |
|---|---|---|
| Telephone and email correspondence with an Inflammatory Bowel Disease NurseThe IBD pediatric-adult transition nurse will send an email each month containing: Brief Questionnaire: A link to a secured website will be provided where participants will respond to a questionnaire. Direct Nurse Contact: Telephone and email correspondence with an Inflammatory Bowel Disease Nurse Educational module: Every other month, we will include in the email another link to an optional educational module that will be part of a curriculum to facilitate transition readiness. MyHealth Passport Study Questionnaire: A personalized link to a more comprehensive study questionnaire similar to the baseline questionnaire will be emailed in the 6th and 12th (final) email. | Behavioural | Regular telephone and email access to an IBD Nurse |
| Minimal Intervention ArmPatients randomized to the control group will have receive email based questionnaires and information relating to the MyHealth Passport application. This intervention is not expected to significantly improve outcomes. | Behavioural | Minimal Intervention |
Primary outcome
Change in Patient Satisfaction
Time frame: Patient satisfaction will be assessed prior to transfer of care (within 3 months from the time of randomization) and again post-transfer of care (within 12 months from the time of randomization).
A comprehensive study questionnaire containing the CACHE questionnaire will be administered to assess patient satisfaction. Reference: Casellas F, Ginard D, Vera I, Torrejón A. Development and testing of a new instrument to measure patient satisfaction with health care in inflammatory bowel disease: the CACHE questionnaire. Inflamm Bowel Dis. 2013 Mar;19(3):559-68.
Change in Medication Adherence
Time frame: Medication adherence will be assessed prior to transfer of care (within 3 months from the time of randomization) and again post-transfer of care (within 12 months from the time of randomization).
Medication adherence will be assessed with a comprehensive study questionnaire containing the Morisky questionnaire. Reference: Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care 1986;24:67-74.
Change in Non-Routine Healthcare Utilization
Time frame: Non-routine healthcare utilization will be assessed retrospectively for 12 months prior to transfer of care and compared to 12 months post-transfer of care.
IBD related clinic visits, admissions to hospital, emergency department visits, endoscopy and operative procedures, imaging procedures will all be recorded via telephone interview with the patient and also via linkage to the Institute of Clinical and Evaluative Sciences Databases which record health claims by Ontario residents . The date of transfer of care to an adult gastroenterologist will be recorded as well as any continuing appointments with a pediatric gastroenterologist beyond the transfer date.
Change in Transition Readiness
Time frame: Transition readiness will be assessed prior to transfer of care (within 3 months from the time of randomization) and again post-transfer of care (within 12 months from the time of randomization).
The Transition Readiness Assessment Questionnaire will be administered. Reference: Sawicki GS, Lukens-Bull K, Yin X, Demars N, Huang IC, Livingood W, Reiss J, Wood D. Measuring the transition readiness of youth with special healthcare needs: validation of the TRAQ--Transition Readiness Assessment Questionnaire. J Pediatr Psychol. 2011 Mar;36(2):160-71.
3 secondary outcomes
Change in Quality of Life
Time frame: Quality of life will be assessed prior to transfer of care (within 3 months from the time of randomization) and again post-transfer of care (within 12 months from the time of randomization).
Change in Disease Activity
Time frame: Disease activity will be assessed prior to transfer of care (within 3 months from the time of randomization) and again post-transfer of care (within 12 months from the time of randomization).
Change in Knowledge of Disease
Time frame: Knowledge of disease will be assessed prior to transfer of care (within 3 months from the time of randomization) and again post-transfer of care (within 12 months from the time of randomization).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Background: PubMed 22677118Bollegala N, Brill H, Marshall JK. Resource utilization during pediatric to adult transfer of care in IBD. J Crohns Colitis. 2013 Mar;7(2):e55-60. doi: 10.1016/j.crohns.2012.05.010. Epub 2012 Jun 5.
- Background: PubMed 15605138Pinzon JL, Jacobson K, Reiss J. Say goodbye and say hello: the transition from pediatric to adult gastroenterology. Can J Gastroenterol. 2004 Dec;18(12):735-42. doi: 10.1155/2004/474232.
- Background: PubMed 11964946Baldassano R, Ferry G, Griffiths A, Mack D, Markowitz J, Winter H. Transition of the patient with inflammatory bowel disease from pediatric to adult care: recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr. 2002 Mar;34(3):245-8. doi: 10.1097/00005176-200203000-00001. No abstract available.
- Background: PubMed 10227345Scal P, Evans T, Blozis S, Okinow N, Blum R. Trends in transition from pediatric to adult health care services for young adults with chronic conditions. J Adolesc Health. 1999 Apr;24(4):259-64. doi: 10.1016/s1054-139x(98)00127-x.
- Background: PubMed 18472377Dabadie A, Troadec F, Heresbach D, Siproudhis L, Pagenault M, Bretagne JF. Transition of patients with inflammatory bowel disease from pediatric to adult care. Gastroenterol Clin Biol. 2008 May;32(5 Pt 1):451-9. doi: 10.1016/j.gcb.2008.01.044. Epub 2008 May 8.
- Background: PubMed 19172125Hait EJ, Barendse RM, Arnold JH, Valim C, Sands BE, Korzenik JR, Fishman LN. Transition of adolescents with inflammatory bowel disease from pediatric to adult care: a survey of adult gastroenterologists. J Pediatr Gastroenterol Nutr. 2009 Jan;48(1):61-5. doi: 10.1097/MPG.0b013e31816d71d8.
- Background: PubMed 19434722Greenley RN, Stephens M, Doughty A, Raboin T, Kugathasan S. Barriers to adherence among adolescents with inflammatory bowel disease. Inflamm Bowel Dis. 2010 Jan;16(1):36-41. doi: 10.1002/ibd.20988.
- Individual participant dataSharing planned: No
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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.
Geoffrey Nguyen, MD, PhD principal investigator
Mount Sinai Hospital, Canada
Anne Griffiths, MD principal investigator
The Hospital For Sick Children, Toronto, Canada
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone and email correspondence with an Inflammatory Bowel Disease Nurse and Minimal Intervention Arm in people with Inflammatory Bowel Disease and Crohn Disease, run by Mount Sinai Hospital, Canada at 3 sites 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: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Patient Satisfaction (time frame: Patient satisfaction will be assessed prior to transfer of care (within 3 months from the time of randomization) and again post-transfer of care (within 12 months from the time of randomization).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02085083, which also lists 7 linked publications.
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 17 Apr 2018.