Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000956101
Ethics application status
Approved
Date submitted
13/06/2019
Date registered
8/07/2019
Date last updated
8/07/2019
Date data sharing statement initially provided
8/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving self management of blood sugar control in people with Type 2 Diabetes.
Scientific title
Reducing Morbidity and Mortality by Initiation of a novel In-Hospital Treatment for Patients with T2DM (REMIT-2-D).
Secondary ID [1] 298485 0
Nil Known
Universal Trial Number (UTN)
U1111-1235-2644
Trial acronym
REMIT-2D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 313265 0
Cardiac condition 313266 0
Condition category
Condition code
Metabolic and Endocrine 311709 311709 0 0
Diabetes
Cardiovascular 311710 311710 0 0
Other cardiovascular diseases
Public Health 311776 311776 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is delivery of a set of diabetes, self-management, health literacy packages and the effect on HbA1C at 6 weeks. The intervention study groups are as follows:

Study group 2:
Study_Self-care, Coping, Sleep, and National Diabetes Service Scheme (NDSS)_Healthy Food Choices

Study group 3:
Study_Self-care, Coping, Sleep, and Study_Eat whole foods and National Diabetes Service Scheme (NDSS) Physical activity

Study group 4:
Study_Self-care, Coping, Sleep AND Study_Eat whole foods and Study_ Muscle resistance activity.

Summary content of health literacy tools developed through evidence and focus groups:
1. Eat fresh whole foods: page 1 the Diabetes wellness wheel, page 2 describes the benefits of healthy eating, page 3 the benefits of drinking water rather than fruit juice, soft drink, alcohol and flavored milk drinks, page 4 suggestions for how to replace processed foods with whole foods, page 5 suggested meal menus and their cost, page 6 shopping trolley quiz - choose what you would put in a healthy shopping basket.
2. Coping with Diabetes and reducing stress: page 1 the Diabetes wellness wheel, page 2 description of healthy environments, sense of belonging, healthy behaviours, coping, resilience and treatment of illness, page 3, make your own coping plan and what to do in an emergency.
3.Diabetes Self-care: page 1 the Diabetes wellness wheel, page 2 to be healthy we need to be aware of what medications you're taking, see a primary care health professional regularly, have regular health checks, advise on foot care, eye care and dental care, page 3 provides resources on how to contact helpful services and websites.
4. Good Sleep, Good Health: page 1 the Diabetes wellness wheel, page 2 the benefits of a good nights sleep, page 3 top tips for getting a good nights sleep, page 4 information about sleep apnoea, insomnia, and shift work and resources for extra help.
5. Muscle resistance Activity: page 1 the Diabetes wellness wheel, page 2 the benefits of physical activity, page 3 instructions on how to do some resistance activity for the upper body (bicep curls, overhead shoulder press, straight arm raise, slide arm raise, holding a 1kg weight in each hand, with 20 repetitions for each exercise and 1-2 mins rest in between. Do these at least 3 days/week) at home at no cost, page 4 instructions on how to do some resistance activity for the lower body(knee/flexion/extension raise, lateral leg raise, toe lifts, straight leg raise, strapping a 1kg weight around each ankle, with 20 repetitions for each exercise and 1-2 mins rest in between. Do these at least 3 days/week) at home at no cost, page 5 resources for extra help.
Summary content of health literacy tools published by National Diabetes Service scheme:
1. Understanding Type 2 Diabetes: 1-page describes what is type 2 diabetes, who is at risk, can it be prevented or cured and provides the NDSS helpline phone number.
2. Making healthy food choices:1-page describes how to make healthy food choices, how to eat regular meals in the right amount, a diagram of a plate with proportions marked for protein, salad/vegetables and carbohydrates and provides the NDSS helpline phone number.
3. Physical Activity: 1-page describes the benefits of physical activity, the types of physical activity and provides the NDSS helpline phone number.

MODE OF DELIVERY: the tools are presented in paper format and are explained to the patient verbally by the study care coordinator. The Care coordinator will then provide the package that the patient is randomised to in a booklet for them to take home along with a free set of weights to do the resistance activity.

INTERVENTION ADMINISTRATION: will be by a single trained Care Coordinator

FREQUENCY AND DURATION: Each patient will answer a set of questionnaires estimated to take 1.5 hours with the assistance of the Care Coordinator. Each patient will have a health literacy tool package explained and provided to them estimated to take up to 30 mins to deliver. There are no further education sessions.

MONITORING OF ADHERENCE; none
Intervention code [1] 314735 0
Behaviour
Intervention code [2] 314780 0
Lifestyle
Comparator / control treatment
Study group 1 is the control who will receive:
Standard factsheets from the Diabetes Australia Foundation (NDSS) on Understanding T2 diabetes, Healthy Food Choices and Physical Activity
Control group
Active

Outcomes
Primary outcome [1] 320397 0
Change in glycated haemoglobin measured by a Haemoglobin A1C test which represents an average blood sugar over 3 months.
Timepoint [1] 320397 0
6 weeks post discharge from hospital
Secondary outcome [1] 371467 0
Change in cholesterol measured by triglyceride via a serum assay
Timepoint [1] 371467 0
Change in cholesterol will be measured at baseline and 6-weeks post discharge from hospital
Secondary outcome [2] 371811 0
Change in diabetes distress measured by the Diabetes Distress scale questionnaire
Timepoint [2] 371811 0
Change in diabetes distress will be measured at baseline and 6 weeks post discharge from hospital.
Secondary outcome [3] 371812 0
Readmission to hospital measured by data linkage of patient data with Department of Health administrative data
Timepoint [3] 371812 0
Readmission will be measured 12 months post discharge from hospital.
Secondary outcome [4] 372030 0
Length of stay for patients readmitted to hospital, measured by data linkage of patient data with Department of Health administrative data.
Timepoint [4] 372030 0
Length of stay will be measured at 12 months post discharge from hospital

Eligibility
Key inclusion criteria
1. Non-Indigenous and Indigenous peoples of age 18 years and over.

2. Patients with Type 2 Diabetes Mellitus with an underlying cardiac condition admitted to hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Non-Indigenous and Indigenous peoples under the age of 18 years.

2. Women who are pregnant.

3. Patients unable to give informed consent.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Random numbers generated by a computer-generated number producing table of random numbers,
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central randomisation (site remote from trials location), sequentially numbered stored on password protected database. Statistician blinded, enrollment personnel allocated treament codes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Adaptive randomisation is used. We will implement a two-stage drop-the-loser design initially comparing three experimental interventions against control. The first stage requires 132 patients, with an average accrual of 10 patients per week this will be achieved after 14 weeks. With an additional 6 weeks follow-up we anticipate an interim analysis at 22 weeks after which the two worse performing experimental interventions will be dropped. Accrual will continue during the first stage’s 8-week follow-up period, thereby shortening the overall study length. At 10 patients per week 80 patients are expected to be accrued, of which 40 will be in the final two arms. The second stage requires a further 66 patients, thereby we anticipate accrual (and treatment) end after 25 weeks with final analysis at 31 weeks after study start. The difference in means with control arm as common reference are multivariate normally distributed allowing for strong control of the type I error rate. Being an early phase trial focusing on proof-of-concept evidence of intervention efficacy, we set the type I error rate to be 10% (one-sided), while maintaining a small type II error rate.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/06/2019
Date of last participant enrolment
Anticipated
6/12/2019
Actual
Date of last data collection
Anticipated
4/12/2020
Actual
Sample size
Target
198
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 13991 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 26769 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 303030 0
Government body
Name [1] 303030 0
Medical Research Future Fund
Country [1] 303030 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Health Translation SA, South Australian Health and Medical Research institute
Address
North Tce
Adelaide, South Australia, 5000
Country
Australia
Secondary sponsor category [1] 303012 0
University
Name [1] 303012 0
Adelaide University
Address [1] 303012 0
Administered by College of Health Sciences, Discipline of Medicine, Adelaide University, North Terrace, Adelaide, South Australia, 5000
Country [1] 303012 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303581 0
Aboriginal Human Research ethics committee
Ethics committee address [1] 303581 0
Ethics committee country [1] 303581 0
Australia
Date submitted for ethics approval [1] 303581 0
18/04/2019
Approval date [1] 303581 0
02/05/2019
Ethics approval number [1] 303581 0
04-19-822
Ethics committee name [2] 303586 0
Central Adelaide Local health Network
Ethics committee address [2] 303586 0
Ethics committee country [2] 303586 0
Australia
Date submitted for ethics approval [2] 303586 0
23/04/2019
Approval date [2] 303586 0
13/06/2019
Ethics approval number [2] 303586 0
HREC/19/CALHN/156

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94154 0
Prof Gary Wittert
Address 94154 0
Nutrition and Metabolism Theme, SAHMRI, North Tce Adelaide, SA 5000.
Country 94154 0
Australia
Phone 94154 0
+61 8 8128 4830
Fax 94154 0
none
Email 94154 0
[email protected]
Contact person for public queries
Name 94155 0
Gary Wittert
Address 94155 0
Nutrition and Metabolism Theme, SAHMRI, North Tce Adelaide, SA 5000.
Country 94155 0
Australia
Phone 94155 0
+61 8 8128 4830
Fax 94155 0
none
Email 94155 0
[email protected]
Contact person for scientific queries
Name 94156 0
Gary Wittert
Address 94156 0
Nutrition and Metabolism Theme, SAHMRI, North Tce Adelaide, SA 5000.
Country 94156 0
Australia
Phone 94156 0
+61 8 8128 4830
Fax 94156 0
none
Email 94156 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will adhere to privacy and confidentiality principles, plus there is only a need to report aggregated data for the results of this study.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.