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

February 4, 2020 updated by: Göteborg University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
    • Huddinge
      • Stockholm, Huddinge, Sweden, 141 86
    • Solna
      • Stockholm, Solna, Sweden, 171 76

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Endpoint after 2.5 years from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Endpoint after 2.5 years from baseline
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.
Endpoint after 2.5 years from baseline
Transition readiness
Time Frame: Change from baseline (16 year) to 18.5 year
Readiness for transition questionnaire RTQ (adolescent version)
Change from baseline (16 year) to 18.5 year
Transition readiness
Time Frame: Change from baseline (16 year) to 18.5 year
Readiness for transition questionnaire RTQ (parent version)
Change from baseline (16 year) to 18.5 year
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.
Endpoint after 2.5 years from baseline
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.
Change from baseline (16 year) to 18.5 year
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.
Endpoint after 2.5 years from baseline
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.
Endpoint after 2.5 years from baseline
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.
Endpoint after 2.5 years from baseline
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.
Endpoint after 2.5 years from baseline
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.
Mean value during study period (16-18.5 year)
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.
From baseline (16 year) to 18.5 year
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.
From baseline (16 year) to 18.5 year
Clinic attendance 1
Time Frame: During and six month after study period
Number of visits. Less number than recommended represent a worse outcome.
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Collaborators

Karolinska University Hospital
The Swedish Research Council
Swedish Council for Working Life and Social Research
Swedish Child Diabetes Foundation
Swedish Diabetes Foundation
Gothenburg Centre for Person-Centred Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 15, 2019

Primary Completion (ANTICIPATED)

January 15, 2024

Study Completion (ANTICIPATED)

June 15, 2024

Study Registration Dates

First Submitted

June 9, 2019

First Submitted That Met QC Criteria

June 19, 2019

First Posted (ACTUAL)

June 21, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/1725-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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