Digital Delivery of Person-centered Transitional Care

NCT06823622 | Recruiting

• 1 other identifier: Digi Stepstones
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Advances in medical care have extended the life expectancy of individuals with congenital and pediatric-onset diseases, leading to an increased need for effective transition programs as these individuals move from pediatric to adult healthcare. The STEPSTONES project in Sweden is designed to evaluate the effectiveness of a person-centered transition program to support teenagers with chronic conditions during this transition. The project's innovative digital adaptation, Digi-STEPSTONES, seeks to address challenges related to accessibility and continuity of care by delivering the program remotely. This study will assess the non-inferiority of the digital program compared to traditional, in-person care, focusing on outcomes such as patient empowerment, transition readiness, and quality of life. Additionally, the project will explore the implementation and scalability of the digital transition model across various chronic conditions. Preliminary studies have highlighted the importance of structured, person-centered care in improving empowerment and other outcomes in adolescents with chronic illnesses. The Digi-STEPSTONES project aims to provide crucial evidence for the digital delivery of transition programs, potentially enhancing the accessibility and effectiveness of care for young people with chronic conditions in Sweden.

Conditions

Asthma in Children; Transplantation

Keywords

Transition; Transfer; Chronic condition; Adolescents; Youth; Young people; Transition program

Outcome Measures

Primary Outcomes (1)

• Patient empowerment

  Gothenburg Young Persons Empowerment Scale (GYPES)

  At baseline T0 when the participant is 16 years with follow up at T1 when the participants are 18.5 years

Secondary Outcomes (2)

• Satisfaction with transition

  18.5y

• Transition readiness

  At baseline T0 when the participant is 16 years with follow up at T1 when the participants are 18.5 years

Other Outcomes (1)

• Transition readiness

  Parents fills out the questionnaire at baseline T0 when their adolescent (participant) is 16 years with follow up at T1 when the participant are 18.5 years

Study Arms (2)

Arm A

EXPERIMENTAL

Arm A involves a pre-test/post-test design where individuals will participate in the digital delivery of the transition program.

Behavioral: Stepstones transition program

Arm B

OTHER

Arm B is a historical comparison cohort that includes participants from two previous RCTs who received the intervention (the transition program) in-person.

Behavioral: Stepstones transition program

Interventions

Stepstones transition program BEHAVIORAL

The STEPSTONES transition program is an 8-component intervention designed to support adolescents with chronic conditions transitioning to adult care. It includes: a transition coordinator (TC), education about the condition, phone support, guidance on transitioning to adult care, parental guidance, peer meetings, a personalized transition plan, and the actual transfer to adult care. The intervention is implemented in five steps, starting with outpatient visits and culminating in the transfer to adult care. Delivered via the "Mitt vårdmöte" digital platform, the program includes the HEADDDSS adolescent health interview and is conducted by trained specialized nurses.

Arm A; Arm B

Eligibility Criteria

• Age: 15 Years - 20 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Participants: Arm A - Literate and Swedish-speaking adolescents with asthma/allergy or went through a solid organ transplantation aged minimum 15 years. Their parents will be asked to fill out one questionnaire (proxy). Arm B: \- Literate and Swedish-speaking adolescents with asthma/allergy or went through a solid organ transplantation aged minimum 15 years. Their parents will be asked to fill out one questionnaire (proxy). Sample size calculation: Arm A: approximately100 patients will be recruited consecutively. Arm B: the approximate sample for individuals who received the intervention in-person is of

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (2)

Queen Silvia Childrens hospital, Sahlgrenska university hospital

Gothenburg, Vastra Gotalandsregionen, 416 50, Sweden

RECRUITING

Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg

Gothenburg, 41674, Sweden

NOT YET RECRUITING

Related Publications (9)

• Vallmark M, Brorsson AL, Sparud-Lundin C, Bratt EL, Moons P, Saarijarvi M, Mora MA. Development and psychometric evaluation of TEXP-Q: a questionnaire measuring transition and transfer experiences in emerging adults with type 1 diabetes. J Patient Rep Outcomes. 2023 Nov 8;7(1):111. doi: 10.1186/s41687-023-00652-1.

  PMID: 37938469 BACKGROUND

• Bratt EL, Mora MA, Sparud-Lundin C, Saarijarvi M, Burstrom A, Skogby S, Fernlund E, Fadl S, Rydberg A, Hanseus K, Kazamia K, Moons P. Effectiveness of the STEPSTONES Transition Program for Adolescents With Congenital Heart Disease-A Randomized Controlled Trial. J Adolesc Health. 2023 Oct;73(4):655-663. doi: 10.1016/j.jadohealth.2023.02.019. Epub 2023 Apr 8.

  PMID: 37032211 BACKGROUND

• Saarijarvi M, Wallin L, Moons P, Gyllensten H, Bratt EL. Implementation fidelity of a transition program for adolescents with congenital heart disease: the STEPSTONES project. BMC Health Serv Res. 2022 Feb 5;22(1):153. doi: 10.1186/s12913-022-07549-7.

  PMID: 35123454 BACKGROUND

• Saarijarvi M, Wallin L, Moons P, Gyllensten H, Bratt EL. Mechanisms of impact and experiences of a person-centred transition programme for adolescents with CHD: the Stepstones project. BMC Health Serv Res. 2021 Jun 10;21(1):573. doi: 10.1186/s12913-021-06567-1.

  PMID: 34112174 BACKGROUND

• 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.

  PMID: 32295780 BACKGROUND

• Acuna Mora M, Saarijarvi M, Moons P, Sparud-Lundin C, Bratt EL, Goossens E. The Scope of Research on Transfer and Transition in Young Persons With Chronic Conditions. J Adolesc Health. 2019 Nov;65(5):581-589. doi: 10.1016/j.jadohealth.2019.07.014. Epub 2019 Sep 17.

  PMID: 31540780 BACKGROUND

• Saarijarvi M, Wallin L, Moons P, Gyllensten H, Bratt EL. Transition program for adolescents with congenital heart disease in transition to adulthood: protocol for a mixed-method process evaluation study (the STEPSTONES project). BMJ Open. 2019 Aug 2;9(8):e028229. doi: 10.1136/bmjopen-2018-028229.

  PMID: 31377699 BACKGROUND

• 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.

  PMID: 30028863 BACKGROUND

• 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.

  PMID: 28420661 BACKGROUND

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A two-arm, comparative, non-inferiority study, using a causal inference methodology will be performed. Arm A involves a pre-test/post-test design where individuals will participate in the digital delivery of the transition program. Arm B is a historical comparison cohort that includes participants from two previous RCTs who received the intervention (the transition program) in-person.

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: February 12, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

SE (2)