ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616001376437p

Ethics application status

Submitted, not yet approved

Date submitted

28/09/2016

Date registered

5/10/2016

Date last updated

5/10/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Fitbit use in congestive heart failure to improve patient motivation and outcomes

Scientific title

Fitbit use in congestive heart failure – A new age technology to improve patient motivation and clinical outcomes

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1185-8329

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Congestive Heart Failure

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention: Weekly motivational text messages + Fitbit device use

The study period will be for approximately 6 months in total and will require the participants to make two visits into the cardiology department of SCGH, with a total intervention stage of 5 months. The first study visit will involve baseline measurements by 3rd year medical students and registered nurses, and will take approximately an hour to complete. The measurements will include a quality of life questionnaire, an initial heart rate recording, waist circumference, a 6MWT and a blood sample. The blood sample will test key biomarkers such as the TnT and BNP concentrations and will be stored for later testing (this will be explained to the participant). Each participant will be provided with a Fitbit device for the duration of the study.

Once baseline measurements are obtained, each participant will be randomised into either an intervention or control group. The intervention period will run for approximately 5 months in duration. Each participant will also have weekly heart rate recordings analysed. Fitbit patients will have the heart rate measured using the Fitbit device, while patients with a pacemaker will have a weekly recording obtained from their pacemaker for analysis.

The second study visit will occur 5 months after the first visit. It will also take an hour to complete and will involve a follow up set of measurements. The follow up measurements will include a quality of life questionnaire, heart rate recording, waist circumference, a 6MWT and another blood sample (assessing key biomarkers). Each participant will also continue their normal exercise regime throughout this intervention period as part of their exercise rehabilitation program for congestive heart failure.

With the weekly motivational text messages, each participant will receive a similarly structured message which will be as follows:
Week 1: Congratulations - you have completed XX steps so far this week. Do you think you could set and reach a higher goal next week?
Week 2: Did you know you can increase your activity without a dedicated exercise session today? For example, instead of taking the elevator, you could take the stairs.
Week 3: Exercising helps you produce endorphins, which can make you feel more positive. Think of how you can make exercising a regular habit for you.
Week 4: You’ve reached XX steps this week – great work!
Week 5: You’ve completed XX steps this week. For access to your activity information, go to my.selfehealth.co and click on ‘My Activity’.
Week 6: Exercise can come in different forms. If you’re getting bored of running and walking, perhaps try something else like a dance lesson or yoga class instead.
Week 7: Exercise can decrease your risk of chronic disease. Most people know that exercise is good for them but find difficult to make it a habit. What is a fun exercise for you?
Week 8; We know it can be hard to find time to exercise, but planning ahead when and where you will exercise can help you achieve your goals.
Week 9: You’ve completed XX steps this week. Keep up the good work. Did you know you can access your activity information via the self eHealth app at any time?
Week 10: You’ve completed XX steps this week. Well done. Including activity in your daily routine helps make it easier to maintain.
Week 11: Well done on completing over XX steps this week. How many more steps do you think you could complete before the end of this week?
Week 12: Sometimes exercising might feel like a chore. That’s fine; many people have similar feelings but once they start exercising they feel more energised.

Due to logistical and time issues with undertaking the measurements for a relatively big number of participants, study visits and the intervention period will be staggered over a 3 month period. This allows for both chief investigators and other staff involved to undertake participant measurements of roughly 10 participants per week, acting conservatively, although this number may vary on a week to week basis.

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Devices

Comparator / control treatment

Control: Weekly neutral text messages + Fitbit device use

In comparison to the intervention group, the control group will receive neutral weekly motivational text messages, and will continue their exercise regime (as part of their normal exercise rehabilitation program for congestive heart failure) with their allocated Fitbit device only.

Weekly neutral text messages will be structured as follows:
Week 1: You have completed XX steps this week
Week 2: You have completed XX steps this week
Week 3: You have completed XX steps this week
Week 4: You have completed XX steps this week
Week 5: You have completed XX steps this week
Week 6: You have completed XX steps this week
Week 7: You have completed XX steps this week
Week 8; You have completed XX steps this week
Week 9: You have completed XX steps this week
Week 10: You have completed XX steps this week
Week 11: You have completed XX steps this week
Week 12: You have completed XX steps this week

Control group

Active

Outcomes

Primary outcome [1]

6 minute walking test distance

Timepoint [1]