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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03994536
• Other study ID #: 2018/1725-31
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2019
• Est. completion date: June 15, 2024

Study information

• Verified date: February 2020
• Source: Göteborg University
• Contact: Carina Sparud Lundin, PhD
• Phone: +46317866389
• Email: carina.s-lundin[@]fhs.gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Sweden	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

Sponsors (7)

Lead Sponsor	Collaborator
Göteborg University	Gothenburg Centre for Person-Centred Care, Karolinska University Hospital, Swedish Child Diabetes Foundation, Swedish Diabetes Foundation, Swedish Research Council for Health, Working Life and Welfare (FORTE), The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (7)

Acuña 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. — View Citation

Acuña 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. — View Citation

Acuña Mora M, Sparud-Lundin C, Burström Å, 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. — View Citation

Burström Å, Acuna Mora M, Öjmyr-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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Transition readiness	Readiness for transition questionnaire RTQ (adolescent version). These questionnaires examine two aspects. First, the overall transition readiness is assessed, using two items ranging from 1 to 4. The sum of these two items results in a score ranging from 2 to 8. Second, the frequency of adolescent responsibility and parental involvement are reported in 10 different health behaviours, on a ?ve-point Likert scale. Each variable results in a total score ranging from 10 to 40, and higher scores indicate higher adolescent responsibility or parental involvement, respectively.	Endpoint after 2.5 years from baseline
Secondary	Transition readiness	Readiness for transition questionnaire RTQ (parent version). These questionnaires examine two aspects. First, the overall transition readiness is assessed, using two items ranging from 1 to 4. The sum of these two items results in a score ranging from 2 to 8. Second, the frequency of adolescent responsibility and parental involvement are reported in 10 different health behaviours, on a ?ve-point Likert scale. Each variable results in a total score ranging from 10 to 40, and higher scores indicate higher adolescent responsibility or parental involvement, respectively.	Endpoint after 2.5 years from baseline
Secondary	Transition readiness	Readiness for transition questionnaire RTQ (adolescent version)	Change from baseline (16 year) to 18.5 year
Secondary	Transition readiness	Readiness for transition questionnaire RTQ (parent version)	Change from baseline (16 year) to 18.5 year
Secondary	Health behavior	Health Behaviour Scale. Health behaviours are measured with the Health Behavior Scale-CHD. Health behaviours are 'activities a person undertakes to maintain or improve health and prevent diseases'.30 This scale assesses alcohol consumption, tobacco use, dental care and physical activity. The scale has 15 items that help to calculate three summary risk scores: substance use (score 0-100), dental hygiene (score 0-100) and total health risk score (score 0-100). Higher risk scores represent unhealthier behaviours.	Endpoint after 2.5 years from baseline
Secondary	Health behavior	Health Behaviour Scale. Health behaviours are measured with the Health Behavior Scale-CHD. Health behaviours are 'activities a person undertakes to maintain or improve health and prevent diseases'.30 This scale assesses alcohol consumption, tobacco use, dental care and physical activity. The scale has 15 items that help to calculate three summary risk scores: substance use (score 0-100), dental hygiene (score 0-100) and total health risk score (score 0-100). Higher risk scores represent unhealthier behaviours.	Change from baseline (16 year) to 18.5 year
Secondary	General Quality of Life	DISABKIDS Chronic Generic Measure - DCGM-12 measure general quality of life and the level of distress caused by a chronic disease.The short-form of the DISABKIDS chronic generic module consists of 12 five-point Likert-scaled items assigned to the three domains: mental, social and physical. Higher scores represents better outcome.	Endpoint after 2.5 years from baseline
Secondary	Health Related Quality of Life	DISABKIDS Diabetes Module (DM) consists of 13 five-point Likert scaled items and has two scales, an Impact and a Treatment scale. The Impact scale describes emotional reactions of needing to control every day life, and to restrict one`s diet, the Treatment scale refers to carrying equipment and planning treatment. Higher scores represents better outcome.	Endpoint after 2.5 years from baseline
Secondary	Diabetes Burden	Check your Health measures self-perceived physical and emotional health, social relationships, and general QoL on four vertical thermometer scales, ranging from 0 to 100, with 0 indicating low self-perceived health. Each scale indicates self-perceived health with diabetes and, on the same scale, self-perceived health without diabetes. The measured difference between self-perceived health with and without diabetes is defined as the burden of diabetes.	Endpoint after 2.5 years from baseline
Secondary	HbA1c	Glycaemic control measured as HbA1c (mmol/mol), using a capillary test and analysed using the DCA 2000 apparatus (Siemens Medical Solution Diagnostics, Mölndal, Sweden). Higher values represent av worse outcome.	Endpoint after 2.5 years from baseline
Secondary	HbA1c	Glycaemic control measured as HbA1c (mmol/mol), using a capillary test and analysed using the DCA 2000 apparatus (Siemens Medical Solution Diagnostics, Mölndal, Sweden). Higher values represent av worse outcome.	Mean value during study period (16-18.5 year)
Secondary	Hypoglycemic events	Number of severe hypoglycemic events requiring assistance from others. Higher numbers represent a worse outcome.	From baseline (16 year) to 18.5 year
Secondary	Diabetic ketoacidosis	Number of diabetic ketoacidoses requiring hospital care. Higher numbers represent a worse outcome.	From baseline (16 year) to 18.5 year
Secondary	Clinic attendance 1	Number of visits. Less number than recommended represent a worse outcome.	During and six month after study period
Secondary	Clinic attendance 2	Time between last visit in pediatric care and first visit in adult care. Longer time between visits represents a worse outcome.	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