Clinical trial NCT03994536: Effectiveness of a Transition Program for Adolescents With Type 1 Diabetes in the Transition to Adulthood
Official title: Effectiveness of a Person-Centred Transition Program to Empower Adolescents With Type 1 Diabetes in the Transition to Adulthood: the STEPSTONES-DIAB Project
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Transfer to adult care
Continuity of patient care
Transition program
Empowerment
Adolescents
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
name: Swedish Child Diabetes Foundation
name: Swedish Diabetes Foundation
name: Gothenburg Centre for Person-Centred Care
name: The Swedish Research Council
name: Swedish Council for Working Life and Social Research
First posted: 2019-06-21
Enrollment: 140
Sex: ALL
Minimum age (years): 16
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The transfer of young people with type 1 diabetes (T1D) to adult care occurs during a critical period of life, while many young people with T1D have unsatisfactory glycemic control. The preparation to take over responsibility for their health and self-care as well as increasing their participation in care are important aspects for strengthening people's own ability, an important component of person-centered care. STEPSTONES-DIAB aims to evaluate the effectiveness of a person-centred transition program for adolescents with T1D to empower them to become active partners in their care. The study is conducted at two hospitals in Stockholm, Sweden where 140 patients will be randomized to either a structured, person-centered transition program over a 2.5 -year period or to usual care. Outcome measures is empowerment, participation and responsibility in care, health status, glycemic control as well as the participants' experiences of care during transfer.

Detailed description: Type 1 diabetes (T1D) is one of the most common chronic diseases in childhood. Each year, nearly 86 000 children around the world develop T1D. The annual mean incidence rates varies from 0.1-60/100000 with Sweden as one of the "top" incidence countries. Within diabetes care, most health care professionals agree that a lack of effective transfer from pediatric to adult care may contribute to insufficient continuity of health care and increased risk for adverse outcomes in young adults with T1D diabetes. In order to help the adolescent in the transitions to adulthood and adult care, transitions programs have been proposed as a complex intervention with the objective of maximizing lifelong functioning and potential through appropriate healthcare services. Therefore, research on transition and transfer, and on interventions that have the potential to improve both these clinical processes, is important.

Patient empowerment is recognized as an essential element of transition interventions. Through the promotion of patient empowerment the adolescents can become active partners in their care and have the knowledge and capacity to make decisions that affect their life and health status. The purpose of this study is to assess the effectiveness of a transition program for adolescents with type 1 diabetes within a randomized controlled trial. During the course of the study, participants will be part of a transition program or receive usual care before being transferred to adult care. The primary outcome is level of empowerment and secondary outcomes include health behavior as well as diabetes specific and transfer specific variables.

The investigators will assess the effectiveness of the transition program by comparing the level of empowerment (primary outcome) between the participants who received usual care and those who participated in the transition program. A higher level of empowerment from the group part of the intervention is expected. The economic evaluation entails an impact budget assessment and a cost-effectiveness analysis.

Eligibility criteria: Inclusion Criteria:

* Literate
* Swedish-speaking
* Diagnosed with type 1 diabetes (one year duration)
* Age: 16 years

Exclusion Criteria:

* Conditions affecting cognitive abilities
* If other diagnosis are present, type 1 diabetes must be the primary diagnosis

Primary outcomes:
measure: Level of empowerment
timeFrame: Endpoint after 2.5 years from baseline
Secondary outcomes:
measure: Transition readiness
timeFrame: Endpoint after 2.5 years from baseline
measure: Transition readiness
timeFrame: Endpoint after 2.5 years from baseline
measure: Transition readiness
timeFrame: Change from baseline (16 year) to 18.5 year
measure: Transition readiness
timeFrame: Change from baseline (16 year) to 18.5 year
measure: Health behavior
timeFrame: Endpoint after 2.5 years from baseline
measure: Health behavior
timeFrame: Change from baseline (16 year) to 18.5 year
measure: General Quality of Life
timeFrame: Endpoint after 2.5 years from baseline
measure: Health Related Quality of Life
timeFrame: Endpoint after 2.5 years from baseline
measure: Diabetes Burden
timeFrame: Endpoint after 2.5 years from baseline
measure: HbA1c
timeFrame: Endpoint after 2.5 years from baseline
measure: HbA1c
timeFrame: Mean value during study period (16-18.5 year)
measure: Hypoglycemic events
timeFrame: From baseline (16 year) to 18.5 year
measure: Diabetic ketoacidosis
timeFrame: From baseline (16 year) to 18.5 year
measure: Clinic attendance 1
timeFrame: During and six month after study period
measure: Clinic attendance 2
timeFrame: Number of months between the last visit in pediatric care, pre-transfer and the first visit in adult care, post-transfer, assessed up to 2 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Children's Outpatient Diabetes Clinics, Astrid Lindgrens Children's Hospital, Karolinska University Hospital
state: Huddinge
city: Stockholm
country: Sweden
facility: Children's Outpatient Diabetes Clinics, Astrid Lindgrens Children's Hospital, Karolinska University Hospital
state: Solna
Study officials:
References:
citation: Hilderson D, Moons P, Van der Elst K, Luyckx K, Wouters C, Westhovens R. The clinical impact of a brief transition programme for young people with juvenile idiopathic arthritis: results of the DON'T RETARD project. Rheumatology (Oxford). 2016 Jan;55(1):133-42. doi: 10.1093/rheumatology/kev284. Epub 2015 Aug 28.
citation: Hilderson D, Westhovens R, Wouters C, Van der Elst K, Goossens E, Moons P. Rationale, design and baseline data of a mixed methods study examining the clinical impact of a brief transition programme for young people with juvenile idiopathic arthritis: the DON'T RETARD project. BMJ Open. 2013 Dec 2;3(12):e003591. doi: 10.1136/bmjopen-2013-003591.
citation: Small N, Bower P, Chew-Graham CA, Whalley D, Protheroe J. Patient empowerment in long-term conditions: development and preliminary testing of a new measure. BMC Health Serv Res. 2013 Jul 8;13:263. doi: 10.1186/1472-6963-13-263.
citation: Acuna Mora M, Sparud-Lundin C, Bratt EL, Moons P. Person-centred transition programme to empower adolescents with congenital heart disease in the transition to adulthood: a study protocol for a hybrid randomised controlled trial (STEPSTONES project). BMJ Open. 2017 Apr 17;7(4):e014593. doi: 10.1136/bmjopen-2016-014593.
citation: Acuna Mora M, Sparud-Lundin C, Burstrom A, Hanseus K, Rydberg A, Moons P, Bratt EL. Patient empowerment and its correlates in young persons with congenital heart disease. Eur J Cardiovasc Nurs. 2019 Jun;18(5):389-398. doi: 10.1177/1474515119835434. Epub 2019 Mar 5.
citation: Burstrom A, Acuna Mora M, Ojmyr-Joelsson M, Sparud-Lundin C, Rydberg A, Hanseus K, Frenckner B, Nisell M, Moons P, Bratt EL. Parental uncertainty about transferring their adolescent with congenital heart disease to adult care. J Adv Nurs. 2019 Feb;75(2):380-387. doi: 10.1111/jan.13852. Epub 2018 Oct 18.
citation: Acuna Mora M, Luyckx K, Sparud-Lundin C, Peeters M, van Staa A, Sattoe J, Bratt EL, Moons P. Patient empowerment in young persons with chronic conditions: Psychometric properties of the Gothenburg Young Persons Empowerment Scale (GYPES). PLoS One. 2018 Jul 20;13(7):e0201007. doi: 10.1371/journal.pone.0201007. eCollection 2018.
citation: Brorsson AL, Bratt EL, Moons P, Ek A, Jelleryd E, Torbjornsdotter T, Sparud-Lundin C. Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol. BMJ Open. 2020 Apr 14;10(4):e036496. doi: 10.1136/bmjopen-2019-036496.