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

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ClinicalTrials.gov Identifier: NCT03994536
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : August 5, 2019
Sponsor:
Collaborators:
Karolinska University Hospital
Swedish Child Diabetes Foundation
Swedish Diabetes Foundation
Gothenburg Centre for Person-Centred Care
The Swedish Research Council
Swedish Research Council for Health, Working Life and Welfare (FORTE)
Information provided by (Responsible Party):
Göteborg University

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: A Person-Centred Transition Program to Empower Adolescents With Type 1 Diabetes in the Transition to Adulthood: the STEPSTONES-DIAB Project Other: Standard care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : January 15, 2024
Estimated Study Completion Date : June 15, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: 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.
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.

Experimental: 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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Transition readiness [ Time Frame: Endpoint after 2.5 years from baseline ]
    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.

  2. Transition readiness [ Time Frame: Endpoint after 2.5 years from baseline ]
    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.

  3. Transition readiness [ Time Frame: Change from baseline (16 year) to 18.5 year ]
    Readiness for transition questionnaire RTQ (adolescent version)

  4. Transition readiness [ Time Frame: Change from baseline (16 year) to 18.5 year ]
    Readiness for transition questionnaire RTQ (parent version)

  5. Health behavior [ Time Frame: Endpoint after 2.5 years from baseline ]
    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.

  6. Health behavior [ Time Frame: Change from baseline (16 year) to 18.5 year ]
    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.

  7. General Quality of Life [ Time Frame: Endpoint after 2.5 years from baseline ]
    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.

  8. Health Related Quality of Life [ Time Frame: Endpoint after 2.5 years from baseline ]
    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.

  9. Diabetes Burden [ Time Frame: Endpoint after 2.5 years from baseline ]
    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.

  10. HbA1c [ Time Frame: Endpoint after 2.5 years from baseline ]
    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.

  11. HbA1c [ Time Frame: Mean value during study period (16-18.5 year) ]
    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.

  12. Hypoglycemic events [ Time Frame: From baseline (16 year) to 18.5 year ]
    Number of severe hypoglycemic events requiring assistance from others. Higher numbers represent a worse outcome.

  13. Diabetic ketoacidosis [ Time Frame: From baseline (16 year) to 18.5 year ]
    Number of diabetic ketoacidoses requiring hospital care. Higher numbers represent a worse outcome.

  14. Clinic attendance 1 [ Time Frame: During and six month after study period ]
    Number of visits. Less number than recommended represent a worse outcome.

  15. 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 ]
    Time between last visit in pediatric care and first visit in adult care. Longer time between visits represents a worse outcome.



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Ages Eligible for Study:   16 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994536


Contacts
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Contact: Carina Sparud Lundin, PhD +46317866389 carina.s-lundin@fhs.gu.se
Contact: Anna-Lena Brorsson, PhD anna-lena.brorsson@ki.se

Locations
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Sweden
Children's Outpatient Diabetes Clinics, Astrid Lindgrens Children's Hospital, Karolinska University Hospital Not yet recruiting
Stockholm, Huddinge, Sweden, 141 86
Contact: Nina Karlsson Forslund, RN       nina.karlsson-forsberg@sll.se   
Contact: Elisabeth Jelleryd, MsC       elisabeth.jelleryd@sll.se   
Children's Outpatient Diabetes Clinics, Astrid Lindgrens Children's Hospital, Karolinska University Hospital Not yet recruiting
Stockholm, Solna, Sweden, 171 76
Contact: Nina Karlsson Forslund, RN       nina.karlsson-forsberg@sll.se   
Contact: Elisabeth Jelleryd, MsC       elisabeth.jelleryd@sll.se   
Sponsors and Collaborators
Göteborg University
Karolinska University Hospital
Swedish Child Diabetes Foundation
Swedish Diabetes Foundation
Gothenburg Centre for Person-Centred Care
The Swedish Research Council
Swedish Research Council for Health, Working Life and Welfare (FORTE)

Publications:

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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03994536     History of Changes
Other Study ID Numbers: 2018/1725-31
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Göteborg University:
Transfer to adult care
Continuity of patient care
Transition program
Empowerment
Adolescents

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases