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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] 289785 0
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 299490 0
Condition category
Condition code
Cardiovascular 300295 300295 0 0
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] 296012 0
Rehabilitation
Intervention code [2] 296013 0
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] 298953 0
6 minute walking test distance
Timepoint [1] 298953 0
Baseline, and 5 months after randomisation
Secondary outcome [1] 328056 0
Quality of life (PROMIS) questionnaire scores
Timepoint [1] 328056 0
Baseline, and 5 months after randomisation
Secondary outcome [2] 328057 0
Heart rate - Assess using Fitbit devices and the pacemaker if the participant has one
Timepoint [2] 328057 0
Baseline, and 5 months after randomisation
Secondary outcome [3] 328058 0
Waist circumference
Timepoint [3] 328058 0
Baseline, and 5 months after randomisation
Secondary outcome [4] 328059 0
B-type natriuretic peptide (BNP) serum concentration
Timepoint [4] 328059 0
Baseline, and 5 months after randomisation
Secondary outcome [5] 328095 0
Troponin T (TnT) serum concentration
Timepoint [5] 328095 0
Baseline, and 5 months after randomisation

Eligibility
Key inclusion criteria
Patients diagnosed with congestive heart failure
Patients under the medical care of the Cardiovascular Medicine Department, SCGH
Aged between 18-75 years old
Able to give informed consent
Medically stable at time of recruitment
60 patients with the additional inclusion criterion of having an internal cardiac pacemaker in situ
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant comorbidities as determined by the principal investigator
Inability to exercise (severe musculoskeletal disorder, advanced valvular heart disease)
Atrial fibrillation patients
Significant history of smoking and alcohol consumption
Patients requiring palliative care for cardiac or other conditions

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/10/2016
Actual
Date of last participant enrolment
Anticipated
14/11/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 6305 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 13840 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 294166 0
University
Name [1] 294166 0
University of Western Australia Cost Centre
Country [1] 294166 0
Australia
Primary sponsor type
University
Name
University of Western Australia Cost Centre
Address
School of Medicine and Pharmacology, University of Western Australia, M503, 35 Stirling Hwy
Crawley, WA 6009
Country
Australia
Secondary sponsor category [1] 292998 0
None
Name [1] 292998 0
Address [1] 292998 0
Country [1] 292998 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 296044 0
Sir Charles Gairdner Group (SCGG) Human Research Ethics Committee (HREC)
Ethics committee address [1] 296044 0
Ethics committee country [1] 296044 0
Australia
Date submitted for ethics approval [1] 296044 0
10/08/2016
Approval date [1] 296044 0
Ethics approval number [1] 296044 0

Summary
Brief summary
An exercise rehabilitation program based in the hospital or home is commonly used to manage patients with congestive heart failure to improve their quality of life. However, the proportion of patients who follow these programs is low. In this project the researchers will assess the use of regular motivational text messaging in keeping you motivated towards your exercise program. This will be looked at using questionnaires about your health and quality of life, and by measuring your walking distance in a 6 minute walking test. The use of physical activity trackers, Fitbits, will also be used to assess your ability as a way of monitoring your health (heart rate and level of exercise) remotely. We will also be measuring your waist circumference and level of key biomarkers in your blood samples at the beginning and end of the study to help monitor your progress, At the end of this study, we hope to have improved our understanding of using these new technologies as a means of improving a patient’s motivation for their rehabilitation programs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67002 0
A/Prof Brendan McQuillan
Address 67002 0
School of Medicine and Pharmacology, University of Western Australia
M503, 35 Stirling Hwy
Crawley, WA 6009
Country 67002 0
Australia
Phone 67002 0
+61865472677
Fax 67002 0
Email 67002 0
[email protected]
Contact person for public queries
Name 67003 0
Brendan McQuillan
Address 67003 0
School of Medicine and Pharmacology, University of Western Australia
M503, 35 Stirling Hwy
Crawley, WA 6009
Country 67003 0
Australia
Phone 67003 0
+61865472677
Fax 67003 0
Email 67003 0
[email protected]
Contact person for scientific queries
Name 67004 0
Brendan McQuillan
Address 67004 0
School of Medicine and Pharmacology, University of Western Australia
M503, 35 Stirling Hwy
Crawley, WA 6009
Country 67004 0
Australia
Phone 67004 0
+61865472677
Fax 67004 0
Email 67004 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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