Value of a pragmatic trial in studies involving
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Transition of care in chronic illness
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Adolescents
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Effectiveness of a mobile application designed to change behaviour
Introduction
Background and rationale
Objectives
Primary objective
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To examine the effectiveness of the TMApp on rates of engagement with adult services in young people with chronic illness (such as type 1 diabetes mellitus, inflammatory bowel disease, cystic fibrosis, mixed connective tissue disorders) transitioning from paediatric to adult care.
Secondary objectives
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To examine the rates of retention with adult services at 12 and 18 months in young people with a chronic illness who have successfully transitioned (i.e. successfully engaged) to adult services.
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To understand how disease control changes during the first 18 months post transition
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To understand if the use of the TMApp can assist with preventing deterioration of chronic illness control in young people in the 12 months post transition.
Trial design
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Audit of 239 young adults aged 18–28 years with type 1 diabetes accessing five adult diabetes services before 30 June 2008 in three geographical regions of New South Wales [23]
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Data were collected between August 2004 and October 2005 through face-to-face interviews with over 200 clinicians in 68 clinical services in tertiary paediatric hospitals in New South Wales, providing information on approximately 4200 patients
Explanation for the choice of comparators
Methods: participants, interventions and outcomes
Study setting
Eligibility criteria
Inclusion criteria
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Current patients of the Sydney Children’s Hospital Network who have a chronic physical illness (defined as a long term physical health condition that is likely to have consequences for the overall wellbeing of a patient if inappropriately managed or left untreated).
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16 years of age and over
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Transitioning to adult healthcare services within the next 12 months
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Consent to use the TransitionMate app and follow-up for 18 months
Exclusion criteria
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Intellectual disability affecting use of mobile phone application
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Primary diagnosis of mental health disorder
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No access to personal smartphone
Who will take informed consent?
Interventions
Intervention description
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Application – TransitionMate mobile application
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Engagement – At least one attendance to the adult service in the preceding 6 months at the 6 months follow-up.
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Retention – At least one further attendance to the adult service in the preceding 6 months at 12 and 18 months follow-up.
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To do list
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Measures of illness control
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Contact list
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Medication Lists
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Images (Take and save photos)
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Mood tracker using words or emojis
Other data collection
Chronic illness | Illness marker |
---|---|
Acquired brain injury | Functional Independence Measure (FIM), the Glasgow Outcome Scale (GOS), and the Disability Rating Scale (DRS) |
Autoimmune thyroid disease | Free T4; Free T3; TSH |
Congenital Adrenal Hyperplasia | 17 OHP; Plasma Renin Ratio; Testosterone, Androstenedione, Dehydroepiandrosterone sulfate (DHEAS) |
Cystic fibrosis | FEV1; Weight |
Duchenne muscular dystrophy | Creatinine kinase; Lung function test; GMFCS |
Epilepsy | Number and frequency of seizures |
Inflammatory bowel disease - Crohn’s, Ulcerative colitis | Weight; CRP; Faecal Calprotectin; ESR |
Diabetes (Type 1 and 2) | HbA1c |
Chronic liver disease, including Glycogen storage disorders and Transplant | Liver function tests and albumin level |
Phenylketonuria | Serum Phe and tyrosine levels |
Systemic lupus erythematosus | Antinuclear antibodies |
Congenital heart disease and rhythm disorders | Exercise stress test; Echocardiography; ECG |
Engagement and retention with adult service
Measures of illness control
Chronic illness | Measure of disease control | Definition of Deterioration |
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Cystic Fibrosis | FEV1 | FEV1 decreased by ≥10% |
Type 1 Diabetes Mellitus | HbA1c | Absolute decrease in HbA1C by ≥ 1% (e.g. 9% reducing to 8%) |
Inflammatory Bowel Disease | CRP Hb | CRP ≥ 75% increase ≥ 10% fall from previous level |
Cystic Fibrosis Inflammatory Bowel Disease | Weight Weight | Weight decreased by ≥5% Weight decreased by ≥5% |
All Chronic illnesses | Hospitalisation | ≥ 1 UNPLANNED hospitalisation related to chronic illness |
Feedback about the TMApp
Criteria for discontinuing or modifying allocated interventions
Strategies to improve adherence to interventions
Relevant concomitant care permitted or prohibited during the trial
Outcomes
Primary outcome
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To measure engagement with adult services, we will review attendance of the participants at adult appointments at 6 months. Engagement is defined by at least one attendance to the adult service in the preceding 6 months at the 6 months follow-up. This is obtained from the adult service or patient self-report via study-specific questionnaires. (Questionnaires in Additional files) and will be supplemented by information from hospital databases. TMApp analytics will provide further information on the TMApp usage.
Secondary outcomes
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To measure retention, we will review attendance of the participants at adult appointments at 12 and 18 months. Retention is defined by at least one further attendance to the adult service in the preceding 6 months at the 12 and 18 months follow-up. This is obtained from the adult service or patient self-report via study-specific questionnaires. (Questionnaires in Additional files 4, 5, 6) and will be supplemented by information from hospital databases.
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To understand change in illness control during the first 18 months post transition, we will review the changes in the markers of illness control from baseline. We will also assess the number of unplanned/ emergency hospital admissions of the participants after their last paediatric appointment. These are obtained from the adult service or patient self-report via study-specific questionnaires. (Questionnaires in Additional files 4, 5, 6) and will be supplemented by information from hospital databases.
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To understand if the use of the TMApp can assist with preventing deterioration of chronic illness control in young people in the 12 months post transition, we will analyse the changes in illness control with TMApp usage data. This will be obtained from TMApp analytics as well as adult service or patient self-report via study-specific questionnaires. (Questionnaires in Additional files 4, 5, 6) which will be supplemented by information from hospital databases.
Participant timeline
Example procedures
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Assessment/ Procedure
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Initial Assessment (*Penultimate or Final Paediatric appointment
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6 months
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12 months
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18 months
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Informed Consent
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x
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Demographic Information including standard transition care received
Including information about Adult Service referred to
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x
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Measure of disease control
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x
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x
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x
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x
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Transition Readiness Assessment Questionnaire
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x
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Kessler Psychological Distress Scale (K-10)
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x
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Download and use TransitionMate app
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x
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x
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x
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Phone call or text message to young person re: attendance/engagement with adult service and measure of disease control
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x
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x
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x
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Phone call or written request to adult service re: attendance/engagement with adult service and measure of disease control
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x
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x
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x
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Semi-structured interview (face-face, Skype or Telephone) about effectiveness of TransitionMate app
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x
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