Effectiveness of a Transition Program for Adolescents With Type 1 Diabetes in the Transition to Adulthood

NCT ID: NCT03994536

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-15
• Study Completion Date: 2026-06-15

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group: transition program

Participants 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.

Group Type: EXPERIMENTAL

A Person-Centred Transition Program to Empower Adolescents With Type 1 Diabetes in the Transition to Adulthood: the STEPSTONES-DIAB Project

Intervention Type: BEHAVIORAL

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.

Comparison group: Standard care

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.

Group Type: EXPERIMENTAL

Standard care

Intervention Type: OTHER

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.

Interventions

A Person-Centred Transition Program to Empower Adolescents With Type 1 Diabetes in the Transition to Adulthood: the STEPSTONES-DIAB Project

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.

Intervention Type: BEHAVIORAL

Standard care

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: collaborator

Swedish Child Diabetes Foundation

OTHER

Sponsor Role: collaborator

Swedish Diabetes Foundation

UNKNOWN

Sponsor Role: collaborator

Gothenburg Centre for Person-Centred Care

UNKNOWN

Sponsor Role: collaborator

The Swedish Research Council

OTHER_GOV

Sponsor Role: collaborator

Swedish Council for Working Life and Social Research

OTHER

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Children's Outpatient Diabetes Clinics, Astrid Lindgrens Children's Hospital, Karolinska University Hospital

Stockholm, Huddinge, Sweden

Children's Outpatient Diabetes Clinics, Astrid Lindgrens Children's Hospital, Karolinska University Hospital

Stockholm, Solna, Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 26320142 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24302502 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23835131 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28420661 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30834772 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30209810 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30028863 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32295780 (View on PubMed)

Other Identifiers

2018/1725-31

Identifier Type: -

Identifier Source: org_study_id