An interventional study of Patient Navigator and Usual Care in Diabetes, Endocrine System Diseases and Gastro-Intestinal Disorder, sponsored by University of Calgary. Completed at 3 sites in Canada. Open to participants aged 16 Years to 21 Years. Per ClinicalTrials.gov, last updated 2023-06-12.
Sponsored by University of Calgary · Not applicable, Interventional, and Health services research
Among 13 studies in Diabetes Mellitus by University of Calgary — 3 open to participants now, 3 under way, none of them phase 3. Diabetes Mellitus · University of Calgary.
Among the 13 studies in Diabetes Mellitus by University of Calgary, this one is the only one that started in 2018, is one of 6 with no phase, and was the 9th registered.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
Browse Diabetes Mellitus studies →3 of the 13 studies in Diabetes Mellitus by University of Calgary are open now, in 1 country. Recruiting first, the newest first:
University of Calgary · Sites in Canada
University of Calgary · Sites in Canada
University of Calgary
By country, each count listing its studies:
Of the 651 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 198 (30%) stop at 75 or younger; 87 take children under 18; 183 take healthy volunteers.
This study: 16 Years to 21 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 1 · Phase 3 2
First in 2003; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 337 is above the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Median enrollment 42 across the 9 interventional studies, 4,192 across the 4 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
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University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
1 of the studies in Diabetes Mellitus by University of Calgary that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07609381University of CalgaryClinical Information System Impact on Hospitalized Patients With Chronic Disease | 2027-06-01 |
Among the 13 studies in Diabetes Mellitus by University of Calgary, from their registry updates:
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The Transition Navigator Trial (TNT) is a pragmatic randomized controlled trial evaluating the effectiveness of usual care plus a patient navigator service versus usual care plus newsletters and other educational materials, to improve transition outcomes among adolescents aged 16-21 who have chronic health conditions requiring transfer to adult specialty care.
The study will provide urgently needed data to guide health care providers and policy makers regarding the provision of coordinated transition care. These results have the potential to:
Transition is the purposeful, planned movement of adolescent and young adults with chronic health conditions from child-centered to adult-oriented health systems. Transition includes, but is not limited to transfer to adult care. Transfer of care, which occurs during a vulnerable developmental period around age 18 introduces gaps in continuity of care that can lead to detrimental health outcomes in young adults. Therefore, provision of coordinated and developmentally appropriate care during the transition period is necessary to maintain health and to sustain investments made in pediatric health care.
Clinical practice guidelines for transition to adult care recommend the use of patient navigators to coordinate the entry of patients into a complex and unfamiliar adult health care system. Patient navigators provide individualized supports to facilitate medical follow-up and adherence. A limited number of studies have shown that access to a patient navigator during transition decreases drop-out from medical care and disease specific adverse events. No study to date has evaluated the benefits of a patient navigator to improve patient and or health system outcomes, when implemented across multiple chronic disease settings.
Objectives/Methods
A qualitative study sampling participants randomized into the intervention arm at the beginning and end of the trial will also be undertaken to understand the patient experience.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient Navigator (Social Worker) will assist youth adapt and attach to adult delivered healthcare for up to 24 months. Participants will receive 5 issues of a provincial generic newsletter on topics around transition. Participants will be asked to complete a health questionnaire at baseline and 4 more times during 24 months. Participants will be asked to complete a transition readiness questionnaire at baseline and 4 more times during 24 months. Participants will be provided the opportunity to journal online about their experiences. Up to 100 participants will be provided the opportunity to be interviewed at baseline and end of study about their transition experience.
Other: Patient Navigator
Youth will receive usual care from their pediatric clinics in preparation and transfer to adult care. Participants will receive 5 issues of a provincial generic newsletter on topics around transition. Participants will be asked to complete a health questionnaire at baseline and 4 more times during 24 months. Participants will be asked to complete a transition readiness questionnaire at baseline and 4 more times during 24 months. Participants will be provided the opportunity to journal online about their experiences.
Other: Usual Care
Social worker/Patient Navigator will be assigned to follow youth in adult care for up to 24 months to assist youth adapt and attach to adult delivered healthcare
Whatever processes are in place in a variety of clinics to support transfer from pediatric to adult care in the pediatric clinics
Health services utilization
verification of health services utilized by up to 600 participants collected via personal health numbers (e.g. National Ambulatory Care Reporting System; Alberta Ambulatory Care Reporting System; Discharge Abstract Database; Physician Claims)
Time frame: 12 to 24 months
cost analysis
did the intervention save high cost service provision
Time frame: up to 24 months
Variation in TRAQ (Transition Readiness Questionnaire) scores
Variation in TRAQ scores; comparing intervention and non-intervention arm
Time frame: Enrollment and 3 subsequent times in 24 months
Variation in SF-12 Scores
Participant reported mental and physical health
Time frame: Enrollment and 3 subsequent times in 24 months
Youth/Caregiver Satisfaction
Qualitative Interviews with sampling of participants from patient navigator intervention arm
Time frame: after 12 to 24 months
Plan to share: No
Ran from Feb 2018 to primary completion in Aug 2021, 42 months.
Of 1,583 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 42 months is above that.
Counting every sponsor, half of 1,743 studies reached it within 21 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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