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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]

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

Condition category

Condition code

Renal and Urogenital

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]

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]

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]