Authors
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Queensland University of Technology -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2012
INTERVENTION: National randomised controlled trial of an automated, web‐based program aimed to improve Type 2 diabetes self‐management and dysphoria (depression, anxiety, and diabetes‐specific distress) by primarily targeting physical activity, nutrition, health routines, and emotional well‐being. Being a self‐guided program, participants use the program at their own discretion. The Intervention group are sent an email reminder if they have not logged on in >/= 2 weeks. The prgoram has not set duration, as in, participants are free to access the program indefinitely, although the main trial period is 12 months (or, for participants who choose to be followed up in the future, 5 years). There are three treatment arms in this trial, which involve the (i) usual care, (ii) wait‐list control, and (iii) intervention arms. Usual care receives access to limited components of the full program throughout the trial (information resources, quizzes, and the health routines program module). The wait‐list control arm receives access only to information resources and brief quizzes for the initial 3 months of participation, and then receives full program access. The intervention arm receives access to the full OnTrack Diabetes program. This includes information resources and brief quizzes on diabetes self‐care (as accessible by treatment arms i and ii); self‐monitoring tools and automated feedback graphs for physical activity and nutrition goal progress, blood glucose levels (daily highest and lowest), and mood (daily best and worst); access to My Diary, which is an electronic diary; and signposts for physical activity, eating, health routines, emotional wellbeing, and keeping ontrack, which each contain interactive tools based on cognitive behavioural therapy techniques of goal‐setting, planning, problem‐solving, etc, as well as mindfulness and meditation resources. CONDITION: Dysphoria Type 2 diabetes PRIMARY OUTCOME: Glycaemic control (glyosylated haemoglobin level; HbA1c) Mood (depression, anxiety, diabetes‐specific distress symptoms, asmeasured by the DASS‐21, and two sub‐scales of the Diabetes Distress Scale. SECONDARY OUTCOME: Diabetes self‐care behaviours (physical activity participation, dietary intake, medication adherence...) INCLUSION CRITERIA: (a)Type 2 diabetes diagnosis >/= 3 months; (b)aged 18‐75; reside in Australia; (c)HbA1c >/= 6.5%; (d)stable medication type >/= 3 months; (e)stable medication dose >/= 4 weeks; (f)access to computer with internet at least weekly. ; Physical activity participation is measured by the Active Australia Survey and Time Line Follow‐back procedure (by phone interview); nutrition intake is assessed using the time line follow back procedure; and diabetes self‐care is assessed by the Diabetes Self‐care Activities Survey and the AusDiab Diabetes Self‐Care Survey. Program cost‐effectiveness, as assessed using the Health Services Utilisation survey and self‐reported medication intake. Qualitative outcomes ‐ program acceptability, user satisfaction and acceptance, program usability, utility and implementation feasibility, as measured by the OnTrack Diabetes Evaluation survey ‐ devised by Principal Investigator Kavanagh and CI Cassimatis, and by brief phone interview. Quality of life, as measured by the SF‐36 Quality of Life Questionnaire and the EQ‐5D. Self‐efficacy for diabetes self‐care, as measured by Kavanagh et al.'s Diabetes Self‐Efficacy Scale.
Epistemonikos ID: 7e46db90d3a9e3798269bbdd9ee73d92d9dbbb4f
First added on: Aug 22, 2024