Type 1 DiabetesNCT03994536
Effectiveness of a Transition Program for Adolescents With Type 1 Diabetes in the Transition to Adulthood
A study testing A Person-Centred Transition Program to Empower Adolescents With Type 1 Diabetes in the Transition to Adulthood: the STEPSTONES-DIAB Project in people with Type 1 Diabetes, run by Göteborg University at 2 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 16 to 16 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- A Person-Centred Transition Program to Empower Adolescents With Type 1 Diabetes in the Transition to Adulthood: the STEPSTONES-DIAB Project
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesSweden
- Study dates
- 15 Aug 2019to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Literate
- Swedish-speaking
- Diagnosed with type 1 diabetes (one year duration)
- Age: 16 years
Who cannot join
- Conditions affecting cognitive abilities
- If other diagnosis are present, type 1 diabetes must be the primary diagnosis
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Children's Outpatient Diabetes Clinics, Astrid Lindgrens Children's Hospital, Karolinska University Hospital
Stockholm, Huddinge, 141 86
Children's Outpatient Diabetes Clinics, Astrid Lindgrens Children's Hospital, Karolinska University Hospital
Stockholm, Solna, 171 76
About this study
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
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.
Read the 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
- Being tested
- A Person-Centred Transition Program to Empower Adolescents With Type 1 Diabetes in the Transition to Adulthood: the STEPSTONES-DIAB Project, Standard care
- Keywords
- Transfer to adult care, Continuity of patient care, Transition program, Empowerment, Adolescents
- Medical subject headings
- Diabetes Mellitus, Type 1, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Person-Centred Transition Program to Empower Adolescents With Type 1 Diabetes in the Transition to Adulthood: the STEPSTONES-DIAB ProjectBehavioural
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.
Standard careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: transition program | Experimental | 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. Receives: Behavioral: A Person-Centred Transition Program to Empower Adolescents With Type 1 Diabetes in the Transition to Adulthood: the STEPSTONES-DIAB Project |
| Comparison group: Standard care | Experimental | 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. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Endpoint after 2.5 years from baseline
Secondary outcomes (15)
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 five-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.
Measured: Endpoint after 2.5 years from baseline
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 five-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.
Measured: Endpoint after 2.5 years from baseline
Transition readiness
Readiness for transition questionnaire RTQ (adolescent version)
Measured: Change from baseline (16 year) to 18.5 year
Transition readiness
Readiness for transition questionnaire RTQ (parent version)
Measured: Change from baseline (16 year) to 18.5 year
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.
Measured: Endpoint after 2.5 years from baseline
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.
Measured: Change from baseline (16 year) to 18.5 year
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.
Measured: Endpoint after 2.5 years from baseline
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.
Measured: Endpoint after 2.5 years from baseline
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.
Measured: Endpoint after 2.5 years from baseline
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.
Measured: Endpoint after 2.5 years from baseline
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.
Measured: Mean value during study period (16-18.5 year)
Hypoglycemic events
Number of severe hypoglycemic events requiring assistance from others. Higher numbers represent a worse outcome.
Measured: From baseline (16 year) to 18.5 year
Diabetic ketoacidosis
Number of diabetic ketoacidoses requiring hospital care. Higher numbers represent a worse outcome.
Measured: From baseline (16 year) to 18.5 year
Clinic attendance 1
Number of visits. Less number than recommended represent a worse outcome.
Measured: During and six month after study period
Clinic attendance 2
Time between last visit in pediatric care and first visit in adult care. Longer time between visits represents a worse outcome.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start15 Aug 2019
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Swedish Child Diabetes Foundation, Swedish Diabetes Foundation, Gothenburg Centre for Person-Centred Care, The Swedish Research Council, Swedish Council for Working Life and Social Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994536
- Sponsor's protocol ID
- 2018/1725-31
- Status last verified
- Mar 2025
- First submitted
- 9 Jun 2019
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 26320142Hilderson 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.
PubMed 24302502Small 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.
PubMed 23835131Acuna 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.
PubMed 28420661Acuna 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.
PubMed 30834772Burstrom 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.
PubMed 30209810Acuna 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.
PubMed 30028863Brorsson 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.
PubMed 32295780
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03994536
- Acronym / sponsor ID
- 2018/1725-31
- Conditions
- Type 1 Diabetes
- Keywords
- Transfer to adult care, Continuity of patient care, Transition program, Empowerment, Adolescents
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Swedish Child Diabetes Foundation, Swedish Diabetes Foundation, Gothenburg Centre for Person-Centred Care, The Swedish Research Council, Swedish Council for Working Life and Social Research
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: transition program | Experimental | Behavioral: A Person-Centred Transition Program to Empower Adolescents With Type 1 Diabetes in the Transition to Adulthood: the STEPSTONES-DIAB ProjectParticipants 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 | Experimental | Other: Standard careParticipants 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. |
Who may qualify
- Ages
- 16 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Literate
- Swedish-speaking
- Diagnosed with type 1 diabetes (one year duration)
- Age: 16 years
Key exclusion criteria (2 listed)
- Conditions affecting cognitive abilities
- If other diagnosis are present, type 1 diabetes must be the primary diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A Person-Centred Transition Program to Empower Adolescents With Type 1 Diabetes in the Transition to Adulthood: the STEPSTONES-DIAB ProjectBehavioral: 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. | Behavioural | Intervention group: transition program |
| Standard careParticipants 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. | Other | Comparison group: Standard care |
Primary outcome
Level of empowerment
Time frame: Endpoint after 2.5 years from baseline
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.
15 secondary outcomes
Transition readiness
Time frame: Endpoint after 2.5 years from baseline
Transition readiness
Time frame: Endpoint after 2.5 years from baseline
Transition readiness
Time frame: Change from baseline (16 year) to 18.5 year
Transition readiness
Time frame: Change from baseline (16 year) to 18.5 year
Health behavior
Time frame: Endpoint after 2.5 years from baseline
Health behavior
Time frame: Change from baseline (16 year) to 18.5 year
General Quality of Life
Time frame: Endpoint after 2.5 years from baseline
Health Related Quality of Life
Time frame: Endpoint after 2.5 years from baseline
Diabetes Burden
Time frame: Endpoint after 2.5 years from baseline
HbA1c
Time frame: Endpoint after 2.5 years from baseline
HbA1c
Time frame: Mean value during study period (16-18.5 year)
Hypoglycemic events
Time frame: From baseline (16 year) to 18.5 year
Diabetic ketoacidosis
Time frame: From baseline (16 year) to 18.5 year
Clinic attendance 1
Time frame: During and six month after study period
Clinic attendance 2
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Background: PubMed 26320142Hilderson 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.
- Background: PubMed 24302502Hilderson 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.
- Background: PubMed 23835131Small 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.
- Background: PubMed 28420661Acuna 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.
- Background: PubMed 30834772Acuna 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.
- Background: PubMed 30209810Burstrom 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.
- Background: PubMed 30028863Acuna 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.
- Derived from this study: PubMed 32295780Brorsson 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Person-Centred Transition Program to Empower Adolescents With Type 1 Diabetes in the Transition to Adulthood: the STEPSTONES-DIAB Project in people with Type 1 Diabetes, run by Göteborg University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of empowerment (time frame: Endpoint after 2.5 years from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03994536, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.