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Trial registered on ANZCTR


Registration number
ACTRN12616001212448
Ethics application status
Approved
Date submitted
24/08/2016
Date registered
1/09/2016
Date last updated
8/02/2019
Date data sharing statement initially provided
8/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Evaluation of iNdividualized Telehealth Intensive Coaching to promote healthy Eating and lifestyle in Chronic Kidney Disease
Scientific title
ENTICE-CKD: the Evaluation of iNdividualized Telehealth Intensive Coaching to promote healthy Eating and lifestyle in Chronic Kidney Disease
Secondary ID [1] 290001 0
Nil Known
Universal Trial Number (UTN)
U1111-1186-8080
Trial acronym
ENTICE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 300011 0
Condition category
Condition code
Renal and Urogenital 299906 299906 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: ENTICE Intervention

Materials and mode of delivery: Telehealth coaching delivered using mobile phones, and a workbook to be provided to all participants. Workbook content is based on the Australian Dietary Guidelines for Adults and contains self-monitoring checklists for salt and food groups serves each day. Workbooks also contain sections to record goals and progress towards those goals.

Procedure: Telehealth coaching aimed at supporting a dietary pattern that includes reduced dietary sodium intake and adheres to Australian Dietary Guidelines. Using a patient-centred approach, intervention delivery is based on empirical evidence that supports a focus on self-management; repeated support and two-way feedback and monitoring and underpinned by Social Cognitive Theory. Each call is anticipated to last 30-45 minutes.

Mode of delivery and number of contacts: Phase 1, Week 0-12: Telehealth coaching (fortnightly coaching calls with text messages scheduled twice per fortnight between calls); Phase 2, Week 12-24: Tailored text messages (2 x 10 minute tailoring phone calls to determine the number, frequency and content of text messages to be provided based on participant’s goals and perceived barriers, educational tips, and reinforcement).

Who and Location: Coaches will be accredited practicing dietitians with training in renal nutrition and will deliver the intervention from a central calling centre within the local health service.

Personalisation: Educational content will be personalised to the participant’s goal for dietary change and associated co-morbidities, which will be continuously assessed at baseline and at each coaching call.

Fidelity: standardised training to coaches in behaviour change, motivational interviewing and renal nutrition and standard call content checklists. Regular peer-review of counselling and fortnightly case discussions with the lead investigator will support counselors in intervention delivery and standardisation.
Intervention code [1] 295709 0
Lifestyle
Comparator / control treatment
Control: Usual care with delayed contact beginning at week 12. Participants randomised to usual care will receive the study workbook, without individualised telehealth coaching. Usual care includes a referral to a nephrologist and may or may not include referral to a dietitian over the 12 week period. Delayed contact will be undertaken at week 12 to 24, including 1-4 text messages sent per week (at the discretion of the participant) to support adherence to a dietary pattern consistent with Australian Dietary Guidelines and lowered dietary sodium intake.
Control group
Active

Outcomes
Primary outcome [1] 299389 0
Feasibility - assessed as a composite of;
1. Recruitment and refusal rate:
2. Retention rate
3. Intervention delivery - including assessing the number, duration and content of coaching phone calls; number and type of text messages actually delivered; number and type of text message responses from participants; and the delivery personnel (including their time spent (as full-time equivalents)).
Timepoint [1] 299389 0
3 and 6 months post commencement of intervention.
Primary outcome [2] 299423 0
Acceptability of the intervention - assessed as a composite of;
- Qualitative interviews with participants to explore their experience and acceptability of the ENTICE intervention.
- Utility and acceptability questionnaire (5-point Likert scale) to assess the acceptability of the two telehealth components to the intervention, including repeated calls, scheduled text messages, technological issues, and what participants perceived utility of the telehealth package was.
Timepoint [2] 299423 0
3 and 6 months post commencement of intervention.
Secondary outcome [1] 327022 0
Safety
a) Maintain blood pressure within safe limits over the 6 month study period, assessed by sphygmomanometry and standard protocols..
Timepoint [1] 327022 0
3 and 6 months post commencement of intervention.
Secondary outcome [2] 327115 0
Safety
b) Maintain blood electrolyte levels within safe and acceptable parameters for CKD, as assessed by 3 monthly pathology collection.
Timepoint [2] 327115 0
3 and 6 months post commencement of intervention.
Secondary outcome [3] 327116 0
Effectiveness
- Dietary intake, measured by Dietary Guidelines Index; Dietary Habits Questionnaire; and scored sodium questionnaire
Timepoint [3] 327116 0
3 and 6 months post commencement of intervention.
Secondary outcome [4] 327321 0
Effectiveness
- Blood pressure, assessed by sphygmomanometry.
Timepoint [4] 327321 0
3 and 6 months post commencement of intervention.
Secondary outcome [5] 327322 0
Cost
- Intervention costs (Information on health care resource use associated with the intervention will be collected, including development, delivery and food costs to participants)
Timepoint [5] 327322 0
3 and 6 months post commencement of intervention.
Secondary outcome [6] 327323 0
Cost
- Healthcare utilisation (downstream healthcare using a patient-report calendar approach)
Timepoint [6] 327323 0
3 and 6 months post commencement of intervention.
Secondary outcome [7] 327324 0
Cost
- Health utility: using ‘Assessment of Quality of Life’ questionnaire (AQoL-4D)
Timepoint [7] 327324 0
3 and 6 months post commencement of intervention.

Eligibility
Key inclusion criteria
a) Adults (>18 years of age) with stage III-IV CKD (eGFR 15-59 ml/min/1.73m2);
b) Have current access to a mobile phone; and
c) Provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Treated with dialysis or kidney transplantation;
b) Deemed unsafe to participate by their nephrologist; or
c) Non-English speaking; and/or unable to read and write in English.

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)
Randomisation will be performed centrally by a computer, and allocation concealed from the investigators
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation (1:1); Stratified by study centre and diabetes
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/09/2016
Actual
3/11/2016
Date of last participant enrolment
Anticipated
15/03/2017
Actual
1/06/2017
Date of last data collection
Anticipated
30/09/2017
Actual
8/12/2017
Sample size
Target
80
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6533 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 6534 0
Nambour General Hospital - Nambour
Recruitment hospital [3] 6535 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 14113 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 14114 0
4560 - Nambour
Recruitment postcode(s) [3] 14115 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 294370 0
Other Collaborative groups
Name [1] 294370 0
Australasian Kidney Trial Network
Country [1] 294370 0
Australia
Funding source category [2] 294371 0
University
Name [2] 294371 0
Bond University
Country [2] 294371 0
Australia
Primary sponsor type
Other Collaborative groups
Name
AKTN
Address
Australasian Kidney Trials Network (AKTN)
The University of Queensland, School of Medicine
Building 1, Level 4, Princess Alexandra Hospital
Ipswich Road, Woolloongabba, QLD 4102
Country
Australia
Secondary sponsor category [1] 293213 0
University
Name [1] 293213 0
Bond University
Address [1] 293213 0
Bond University
14 University Drive
Gold Coast Qld 4229
Country [1] 293213 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295788 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 295788 0
Ethics committee country [1] 295788 0
Australia
Date submitted for ethics approval [1] 295788 0
19/05/2016
Approval date [1] 295788 0
26/07/2016
Ethics approval number [1] 295788 0
HREC/16/QPAH/349

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

Contacts
Principal investigator
Name 68494 0
A/Prof Katrina Campbell
Address 68494 0
2 Promethean Way, Robina, QLD 4226
Faculty of Health Science and Medicine
Bond University
Country 68494 0
Australia
Phone 68494 0
+61 7 559 53573
Fax 68494 0
Email 68494 0
kcampbel@bond.edu.au
Contact person for public queries
Name 68495 0
Jaimon Kelly
Address 68495 0
2 Promethean Way, Robina, QLD 4226
Faculty of Health Science and Medicine
Bond University
Country 68495 0
Australia
Phone 68495 0
+61 7 559 53037
Fax 68495 0
Email 68495 0
jkelly@bond.edu.au
Contact person for scientific queries
Name 68496 0
Katrina Campbell
Address 68496 0
2 Promethean Way, Robina, QLD 4226
Faculty of Health Science and Medicine
Bond University
Country 68496 0
Australia
Phone 68496 0
+61 7 559 53573
Fax 68496 0
Email 68496 0
kcampbel@bond.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.