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Trial registered on ANZCTR


Registration number
ACTRN12616000206426
Ethics application status
Approved
Date submitted
14/02/2016
Date registered
16/02/2016
Date last updated
16/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Survivors of intensive care with type 2 diabetes and the effect of shared care follow-up clinics: the SWEET-AS feasibility study
Scientific title
The effect of shared care follow-up clinics on survivors of intensive care with type 2 diabetes: a randomised controlled feasibility study
Secondary ID [1] 288089 0
None
Universal Trial Number (UTN)
U1111-1177-3392
Trial acronym
SWEET-AS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 296953 0
Type 2 diabetes mellitus 296954 0
Condition category
Condition code
Metabolic and Endocrine 297199 297199 0 0
Diabetes
Physical Medicine / Rehabilitation 297200 297200 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intensive care unit (ICU) survivors in the intervention group will attend a shared care follow-up clinic led by both an intensivist and a diabetologist one month after hospital discharge (+/- 14 days).
Patients in the intervention group will be asked to record their blood glucose level after hospital discharge. When feasible, patients will undergo continuous glucose monitoring in the week prior to clinic attendance.
All patients in the intervention group will receive a 10-minute telephone call from a research coordinator or one of the investigators two weeks after hospital discharge as a reminder of the upcoming clinic appointment. During this phone call, inquiries about significant hypoglycaemic (blood glucose level < 4mmol/L) or hyperglycaemic (blood glucose level > 13mmol/L) blood concentrations will be made. If necessary, changes in treatment will be instituted by the study diabetologist and recorded for each patient. Patients will also undergo blood testing for glycated haemoglobin, complete blood count, electrolytes, renal and liver function, calcium profile, vitamin D level, lipid profile, vitamin B12 level, folate level, iron studies, thyroid function, gonadotrophin levels and testosterone level (male patients) during the week prior to the clinic attendance and prior to the six-month assessment . Fructosamine will be measured as an additional marker of glycaemic control prior to the clinic attendance.
Attendance at a shared care follow-up clinic will occur one month after hospital discharge (+/- 14 days). Patients will be assessed by both an intensivist and a diabetologist at the clinic (two separate 45-minute appointments with each staff member at a single clinic visit). Evaluation will include measurement of vital signs and basic anthropometric data; history-taking regarding diabetes and its treatment; review of blood glucose levels and continuous glucose monitoring data; adjustment of oral hypoglycaemic agents or insulin dosing as required; overall medication review; and cardiovascular risk assessment. Glycaemic targets will be tailored for each patient taking into consideration diabetes duration, diabetes medication regimen, the presence of cardiovascular disease, comorbidities and problems with hypoglycaemia. Blood pressure, lipid profile and requirement for aspirin will be assessed and treatment instituted based upon published guidelines for patients with diabetes . Patients will also undergo evaluation for complications of diabetes including: nephropathy (serum urea and creatinine, spot and, if required 24-hour, urine albumin); distal peripheral sensorimotor neuropathy; cardiovascular autonomic neuropathy using validated cardiovascular autonomic reflex tests performed by ANX 3.0 Autonomic Nervous System monitoring technology (The ANSAR Group, Philadelphia, USA); and macrovascular complications (ischaemic stroke, myocardial ischaemia, peripheral vascular disease) when appropriate.
Patients and, if necessary, their carers will be interviewed and systematically asked about problems which have developed since ICU admission including pain, airway obstruction, symptoms of autonomic neuropathy, sexual dysfunction, concerns about cosmesis, and any impairments of vision, hearing, taste, swallowing, appetite, cognition or communication. Patients will be screened for mobility limitations using the Modified Rivermead Mobility Index and patients of concern will be referred to the physiotherapy department of the hospital. The ICU experience will be discussed and patients will be screened for psychological distress using the Hospital Anxiety and Depression Scale (HADS). Patients with a high HADS score will be referred to the hospital’s psychology clinic if eligible or otherwise to their general practitioner for formation of a Medicare-funded Mental Health Treatment Plan.
Following the above assessments, patients may require referral to additional healthcare professionals including diabetes nurse educators, podiatrists, ophthalmologists, dietitians, and other medical or surgical specialists. All referrals will follow standard hospital pathways. If deemed required, an additional clinic visit will be offered to patients in the intervention group prior to the assessment at six months. A written summary of the outcomes from the clinic visit/s will be provided to each patient’s general practitioner.
All patients in the intervention and control groups will be contacted by mail and telephone and invited back at six months after hospital discharge for outcome assessment. Patients will be assessed by two blinded assessors (an intensivist and a diabetologist) who were not present at the follow-up clinic. The outcome assessment visit will last approximately two hours. Before undergoing this assessment, patients in the intervention group will be instructed not to refer to their prior attendance at the follow-up clinic so that the assessors remain blinded.
A register of attendance at clinic appointments will be kept in order to monitor adherence.
Intervention code [1] 293399 0
Treatment: Other
Intervention code [2] 293400 0
Rehabilitation
Comparator / control treatment
ICU survivors in the control group will have usual care in accordance with standard clinical practice, so that follow-up after ICU will be at the discretion of the primary inpatient hospital team and the patient’s general practitioner.
Control group
Active

Outcomes
Primary outcome [1] 296803 0
The recruitment and retention at six months of all eligible patients. Success of the feasibility study will be determined if complete six-month data is obtained in greater than or equal to 50% of all eligible patients.
Timepoint [1] 296803 0
Six months after hospital discharge
Secondary outcome [1] 319394 0
Anthropometric measurements (weight using a digital scale, height using a stadiometer, waist circumference using a tape measure, BMI calculated from height and weight)
Timepoint [1] 319394 0
Six months after hospital discharge
Secondary outcome [2] 319395 0
Glycaemic control assessed by glycated haemoglobin and serum fructosamine levels, measured using high-performance liquid chromatography and the colorimetric nitroblue tetrazolium assay respectively
Timepoint [2] 319395 0
Glycated haemoglobin will be measured at randomisation, one month after hospital discharge (intervention group only) and six months after hospital discharge. Fructosamine levels will be measured in the intervention group only one month after hospital discharge.
Secondary outcome [3] 319396 0
Distal peripheral neuropathy measured with the Michigan Neuropathy Screening Instrument
Timepoint [3] 319396 0
At one month after hospital discharge (intervention group only) and six months after hospital discharge
Secondary outcome [4] 319397 0
Cardiovascular autonomic neuropathy - testing will be performed using the ANX 3.0 Autonomic Nervous System monitoring technology (The ANSAR Group, Philadelphia, USA) according to the latest consensus guidelines for the diagnosis of autonomic dysfunction. Patients will be categorised as having autonomic dysfunction if two or more tests are outside the age-adjusted reference range. The sympathetic response will be evaluated following the Valsalva manoeuvre for those unable to perform orthostatic provocation.
Timepoint [4] 319397 0
At one month after hospital discharge (intervention group only) and six months after hospital discharge
Secondary outcome [5] 319398 0
Nephropathy assessed by measurement of serum urea, serum creatinine and spot urine testing for macroalbuminuria. If spot urine samples are suggestive of macroalbuminura, urine will be collected for 24 hours and analysed for protein.
Timepoint [5] 319398 0
At one month after hospital discharge (intervention group only) and six months after hospital discharge
Secondary outcome [6] 319404 0
Health-related quality of life (HRQoL) measured with the EuroQol EQ-5D-5L survey
Timepoint [6] 319404 0
At one month after hospital discharge (intervention group only) and six months after hospital discharge
Secondary outcome [7] 319405 0
HRQoL measured by the short form-36 (SF-36) survey
Timepoint [7] 319405 0
At six months after hospital discharge
Secondary outcome [8] 319406 0
Employment status assessed by interview with the participant and/or their carer
Timepoint [8] 319406 0
At enrolment, one month after hospital discharge (intervention group only) and six months after hospital discharge
Secondary outcome [9] 319407 0
Healthcare utilisation - data will be collected using patient monthly diaries and corroborated with hospital inpatient and outpatient clinical records and self-reports at scheduled study visits.
Timepoint [9] 319407 0
At one month after hospital discharge (intervention group only) and six months after hospital discharge
Secondary outcome [10] 319408 0
Resources necessary for the study will be quantified. This includes time and budget requirements for a research coordinator to assist with screening, recruitment and data management, and for staff at the follow-up clinic.
Timepoint [10] 319408 0
At the conclusion of the study period
Secondary outcome [11] 320770 0
The capacity of patients using insulin or sulphonylureas to detect hypoglycaemia and symptoms of hypoglycaemia will be assessed using the Clarke score.
Timepoint [11] 320770 0
At six months after hospital discharge
Secondary outcome [12] 320771 0
Degree of frailty will be assessed using the Clinical Frailty Scale
Timepoint [12] 320771 0
Degree of frailty before hospital admission will be assessed at enrolment and frailty will also be assessed six months after hospital discharge

Eligibility
Key inclusion criteria
Established pre-admission diagnosis of type 2 diabetes mellitus.
Discharge from ICU after five or more days of ICU care.
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Distance from hospital to home greater than 50 kilometres.
Age greater than 85 years.
Major psychiatric illness.
Anticipated to die within six months of ICU discharge.
Pregnancy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes will be used to conceal the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will undergo simple randomisation to either the intervention or control group with a 1:1 allocation by a computerised random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based upon data from the Royal Adelaide Hospital, it is anticipated that there will be 80 eligible patients over the 12-month study period. The study will, accordingly, be deemed successful if complete six-month data is obtained for at least 40 patients (50% of all eligible patients). If participant recruitment is significantly less than this, the study can be extended for a further 6-12 months.
Baseline comparison of patient demographics, severity of illness scores and ICU length of stay will be presented. Glycated haemoglobin will be compared between groups using analysis of covariance. Other scientific outcomes measured at six months after ICU discharge will be compared between groups using a combination of t-tests and chi-square tests.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 4861 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 12368 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 292518 0
Charities/Societies/Foundations
Name [1] 292518 0
Intensive Care Foundation
Address [1] 292518 0
Level 2, 10 levers Terrace
Carlton, Victoria 3053, Australia
Country [1] 292518 0
Australia
Primary sponsor type
Individual
Name
Adam Deane
Address
ICU Research Department,
Level 4 North Wing, Royal Adelaide Hospital,
North Terrace, Adelaide, SA 5000
Australia
Country
Australia
Secondary sponsor category [1] 291225 0
Individual
Name [1] 291225 0
Yasmine Ali Abdelhamid
Address [1] 291225 0
ICU Research Department,
Level 4 North Wing, Royal Adelaide Hospital,
North Terrace, Adelaide, SA 5000
Australia
Country [1] 291225 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293992 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 293992 0
Level 4, Women's Health Centre,
Royal Adelaide Hospital,
North Terrace, Adelaide, SA 5000
Ethics committee country [1] 293992 0
Australia
Date submitted for ethics approval [1] 293992 0
30/07/2015
Approval date [1] 293992 0
27/08/2015
Ethics approval number [1] 293992 0
150818

Summary
Brief summary
For patients that survive ICU there are considerable long-term burdens from being so unwell and the treatments administered in ICU. Because of the long-term health issues it has been proposed that patients who survive ICU should be able to access specialised services via so-called ‘follow-up clinics’. However, the health budget is relatively fixed and so an increase in provision of one health service means that another health service must be reduced. Follow-up clinics are expensive and currently there is no evidence that these follow-up clinics benefit patients. Accordingly, it is imperative that we establish whether these follow-up clinics are helpful or represent a waste of valuable resources.
We will study a very specific group of patients, those with diabetes who have survived ICU. We are studying this group of patients as patients with diabetes make up a significant proportion of patients in ICU. It is also likely, but not yet known, that patients with pre-existing diabetes who survive ICU may be particularly vulnerable to poor health outcomes after ICU.
The intervention we will study is a follow-up clinic run by physicians with expertise in ICU (intensivist) and diabetes (endocrinologist). Our study will provide preliminary information as to whether this type of ICU follow-up clinic is of benefit. If the preliminary data are promising we will undertake a much larger study so that we can precisely measure the effects of these clinics.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62022 0
Dr Yasmine Ali Abdelhamid
Address 62022 0
ICU Research Department,
Level 4 North Wing, Royal Adelaide Hospital,
North Terrace, Adelaide, SA 5000
Australia
Country 62022 0
Australia
Phone 62022 0
+61 8 8222 4624
Fax 62022 0
Email 62022 0
yasmine.aliabdelhamid@sa.gov.au
Contact person for public queries
Name 62023 0
Dr Yasmine Ali Abdelhamid
Address 62023 0
ICU Research Department,
Level 4 North Wing, Royal Adelaide Hospital,
North Terrace, Adelaide, SA 5000
Australia
Country 62023 0
Australia
Phone 62023 0
+61 8 8222 4624
Fax 62023 0
Email 62023 0
yasmine.aliabdelhamid@sa.gov.au
Contact person for scientific queries
Name 62024 0
Dr Yasmine Ali Abdelhamid
Address 62024 0
ICU Research Department,
Level 4 North Wing, Royal Adelaide Hospital,
North Terrace, Adelaide, SA 5000
Australia
Country 62024 0
Australia
Phone 62024 0
+61 8 8222 4624
Fax 62024 0
Email 62024 0
yasmine.aliabdelhamid@sa.gov.au

No information has been provided regarding IPD availability
Summary results
No Results