ewly Diagnosed Type 1 Diabetes Ambulatory Care Service Trial

Completed

• Conditions: Type 1 Diabetes Mellitus; Metabolic and Endocrine - Diabetes; Public Health - Health service research

• Registration Number: ACTRN12612000983808
• Lead Sponsor: Associate Professor Elizabeth Davis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Aged 3-16 years; living within home visit boundaries for Princess Margaret Hospital in the Home service; no immediate family member with existing type 1 diabetes; do not require interpreter; medically suitable for early discharge; no hazards or risks to preclude home visits; no complex social issues or family instability

Exclusion Criteria

Not aged 3-16 years; living outside home visit boundaries for Princess Margaret Hospital in the Home service; immediate family member with existing type 1 diabetes; requires interpreter; medically unsuitable for early discharge; idenitifed hazards or risks that preclude home visits; complex social issues or family instability

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean HbA1c levels (blood test)[3, 6, 9 and 12 months post-diagnosis];Incidence of moderate and severe hypoglycaemia (patient report, clinical notes in the case of hospitalisation)[In the 12 months following diagnosis];Mean readmission rate and hospital bed days (clinical notes)[In the 12 months following diagnosis]

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction score for parents (calculated from 28 question Patient Satisfaction questionnaire developed specifically for this project; uses 5-point Likert scale)[Immediately following discharge (controls) or completion of home-based education (intervention group)];Diabetes knowledge score for parents (calculated from validated 15 multiple choice question Diabetes Knowledge questionnaire)[3 and 9 months post-diagnosis];Quality of Life score for children aged 10 years and over (calculated from validated 52 question Quality of Life Questionnaire; uses 5-point rating scale)[3 and 9 months post-diagnosis];Adjustment and Coping score for adolescents aged 12 years and over and for parents (calculated from validated Problem Areas in Diabetes Questionnaire - there are separate versions for adolescents, parents of adolescents and parents of younger children; all use a 6-point rating scale)[3 and 9 months post-diagnosis]