Effectiveness of a Transition Program for Adolescents With Type 1 Diabetes in the Transition to Adulthood
Effectiveness of a Person-Centred Transition Program to Empower Adolescents With Type 1 Diabetes in the Transition to Adulthood: the STEPSTONES-DIAB Project
1 other identifier
interventional
140
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2019
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2019
CompletedFirst Posted
Study publicly available on registry
June 21, 2019
CompletedStudy Start
First participant enrolled
August 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 15, 2026
April 1, 2025
March 1, 2025
6.8 years
June 9, 2019
March 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Level of empowerment
Gothenburg Young Persons Empowerment Scale (GYPES) will be used to assess the level of empowerment. This scale was developed by the researchers involved in this study and has been tested in a previous cross sectional study in order to determine its psychometric properties in adolescents with congenital heart disease and type 1 diabetes.The five subscales measure: (a) self-perceived level of understanding of their disease (knowledge and understanding); (b) the capacity patients have to handle their disease (personal control); (c) the effect their illness has on their lives and sense of self (identity); (d) the capacity to make decisions along with the healthcare professional (shared decision-making); and (e) the ability to share their experiences and help others who are going through a similar situation (enabling others). The total score ranges from 15 to 75 points, with a higher score reflecting a higher level of empowerment.
Endpoint after 2.5 years from baseline
Secondary Outcomes (15)
Transition readiness
Endpoint after 2.5 years from baseline
Transition readiness
Endpoint after 2.5 years from baseline
Transition readiness
Change from baseline (16 year) to 18.5 year
Transition readiness
Change from baseline (16 year) to 18.5 year
Health behavior
Endpoint after 2.5 years from baseline
- +10 more secondary outcomes
Study Arms (2)
Intervention group: transition program
EXPERIMENTALParticipants come from two clinics and will be randomly allocated to this group. Participants will go through a transition program which will last for 2 years. The intervention will be performed by specialist nurses (transition coordinators) who meet the participants at three occasions during the study period and participants will be offered to meet peers with type 1 diabetes during an adolescent day.
Comparison group: Standard care
EXPERIMENTALParticipants allocated to this group will receive usual care, which includes regular follow-up visits in pediatric diabetes outpatient clinics. Usual care can vary across the two clinics, however, they all include meetings with a nurse and a physician.
Interventions
Behavioral: Transition program Participants will be part of a transition program that aim to prepare them for adult life and adult care wich includes eight key components: 1. A transition coordinator; 2. Education on diabetes, treatments, health behavior, dealing with school, friends; 3. Telephone availability; 4. Information about the adult diabetes service: 5. Guidance of parents; 6. Meeting with peers: 7. A person-centered transition plan; and 8. Preparation and transfer to adult diabetes service.
Participants allocated to this group will receive usual care, which includes regular follow-up visits in pediatric diabetes outpatient clinics. Usual care can vary across the two clinics, however, they all include meetings with a nurse and a physician.
Eligibility Criteria
You may qualify if:
- Literate
- Swedish-speaking
- Diagnosed with type 1 diabetes (one year duration)
- Age: 16 years
You may not qualify if:
- Conditions affecting cognitive abilities
- If other diagnosis are present, type 1 diabetes must be the primary diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Göteborg Universitylead
- Karolinska University Hospitalcollaborator
- Swedish Child Diabetes Foundationcollaborator
- Swedish Diabetes Foundationcollaborator
- Gothenburg Centre for Person-Centred Carecollaborator
- The Swedish Research Councilcollaborator
- Swedish Council for Working Life and Social Researchcollaborator
Study Sites (2)
Children's Outpatient Diabetes Clinics, Astrid Lindgrens Children's Hospital, Karolinska University Hospital
Stockholm, Huddinge, 141 86, Sweden
Children's Outpatient Diabetes Clinics, Astrid Lindgrens Children's Hospital, Karolinska University Hospital
Stockholm, Solna, 171 76, Sweden
Related Publications (8)
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.
PMID: 26320142BACKGROUNDHilderson 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.
PMID: 24302502BACKGROUNDSmall 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.
PMID: 23835131BACKGROUNDAcuna 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.
PMID: 28420661BACKGROUNDAcuna 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.
PMID: 30834772BACKGROUNDBurstrom 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.
PMID: 30209810BACKGROUNDAcuna 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.
PMID: 30028863BACKGROUNDBrorsson 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.
PMID: 32295780DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2019
First Posted
June 21, 2019
Study Start
August 15, 2019
Primary Completion (Estimated)
June 15, 2026
Study Completion (Estimated)
June 15, 2026
Last Updated
April 1, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
Coded files will be available only for research purposes. Information will be given after a letter with the intention of the study has been submitted to the Steering Committee who will determine whether to approve or deny the application.