Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001432101
Ethics application status
Approved
Date submitted
30/09/2019
Date registered
16/10/2019
Date last updated
16/10/2019
Date data sharing statement initially provided
16/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A mobile based multidisciplinary virtual clinic for patients with Heart Failure: A Controlled Randomised Trial of MoTER-HF
Scientific title
A Randomized Controlled Trial to investigate uptake and adherence of patients with Heart Failure to a mobile based multidisciplinary virtual clinic: MoTER-HF project
Secondary ID [1] 299450 0
NIL
Universal Trial Number (UTN)
Trial acronym
MoTER-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 314651 0
Cardiovascular Disease 314652 0
Cardiac Disease 314653 0
Chronic Heart Failure 314654 0
Condition category
Condition code
Cardiovascular 312990 312990 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MoTER-HF intervention include educational information related to Heart Failure (HF), monitoring physical and biological parameters (body weight, blood pressure and pain) and support from healthcare providers. The educational information covers topics including heart HF related educational instructions, healthy lifestyle and body, heart and mind. These information either developed by the CSIRO research team or linked to the related pages of the Heart Foundation Website. We sought authorization from the Heart Foundation.
The intervention will be delivered by a nurse practitioner who acts as mentor and participants will be recruited from the Prince Charles hospital located in Brisbane. The mode of intervention delivery in this study is through smartphone application and its web-portal.
Participants in the intervention group will have access to the MoTER-HF application for the period of three months. Participants are asked to measure their blood pressure and body weight every day using medical devices. They also record their possible pain and heart related symptoms. Participants can access to the relaxation audio tracks embedded in the MoTER-HF app. This audio has developed by the Australian Cancer Council and CSIRO purchased a licence to use the audio in MoTER-HF app. It is expected that each participant spend 30 minutes daily using the app.
The mentor will provide her support through weekly phone calls or face time during the intervention. The length of the phone call depends on patients needs and the mentor's opinion.
The primary outcome of this study is to assess participants' uptake and adherence to smartphone based intervention
Intervention code [1] 315695 0
Lifestyle
Intervention code [2] 315777 0
Treatment: Other
Comparator / control treatment
Routine hospital follow-up. Usual care for patients with HF at hospital outpatient clinic includes 30-45 minutes Nurse Practitioner consultation including physical assessments, medication and blood test review and health education.
Control group
Active

Outcomes
Primary outcome [1] 321558 0
The primary outcome is patients' uptake to the smartphone based intervention.
Patient’s uptake is scored based on the pattern developed for patients’ uptake to clinical interventions. The score of uptake is identified using a table from the book " Riekert, K. A. (2006). Promoting Treatment Adherence: A Practical Handbook for Health Care Providers Integrating Regimen Adherence Assessment into Clinical Practice.: Sage Publication."
Timepoint [1] 321558 0
3 months post baseline assessment
Primary outcome [2] 321559 0
The primary outcome is patients' adherence to the smartphone based intervention. Patient’s adherence is scored based on the pattern developed for patients’ adherence to clinical interventions.The score of adherence is identified using a table from the book "Riekert, K. A. (2006). Promoting Treatment Adherence: A Practical Handbook for Health Care Providers Integrating Regimen Adherence Assessment into Clinical Practice.: Sage Publication."
Timepoint [2] 321559 0
3 months post baseline assessment
Secondary outcome [1] 375353 0
Quality of life measured by European Quality of Life-5 Dimensions (EQ-5D).
Timepoint [1] 375353 0
3 months post baseline assessment
Secondary outcome [2] 375354 0
self-efficacy measured by self-efficacy for managing chronic disease 6 item scale.
Timepoint [2] 375354 0
3 months post baseline assessment
Secondary outcome [3] 375355 0
Body weight measured by patient and send through Bluetooth enabled weight scale.
Timepoint [3] 375355 0
3 months post baseline assessment
Secondary outcome [4] 375356 0
Depression, anxiety and stress will be measured with DASS21.
Timepoint [4] 375356 0
3 months post baseline assessment
Secondary outcome [5] 375357 0
Heart Failure Knowledge will be assessed by the Dutch Heart Failure Knowledge Questionnaire.
Timepoint [5] 375357 0
3 months post baseline assessment

Eligibility
Key inclusion criteria
Patients diagnosed with HF, able to read and write in English, and interested in Information Technology (IT) and smart phone based interventions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants are excluded if they were unable to participate in virtual clinic due to medical care needs, unable to operate a Smartphone for purposes of the trial (e.g. vision, hearing, cognitive or dexterity impairment), had no experience with mobile/smartphones, or were involved in another trial.

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not Applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive analysis :Chi-square, Fishers exact tests and t-tests
Main analysis: ANCOVA

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2019
Actual
Date of last participant enrolment
Anticipated
31/03/2020
Actual
Date of last data collection
Anticipated
31/07/2020
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14916 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 28185 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 303953 0
Charities/Societies/Foundations
Name [1] 303953 0
The Prince Charles Hospital Foundation
Country [1] 303953 0
Australia
Primary sponsor type
Government body
Name
The Australian E-Health Research Center, CSIRO
Address
Level 5 - UQ Health Sciences Building 901/16, Royal Brisbane and Women's Hospital, Herston, QLD 4029
Country Australia
Country
Australia
Secondary sponsor category [1] 304116 0
Hospital
Name [1] 304116 0
THe Prince Charles Hsoptial
Address [1] 304116 0
Building 14, The Prince Charles Hospital, Rode Road, Chermside, QLD 4032
Country [1] 304116 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304453 0
The Prince Charles Hospital Human Research Ethics Committee.
Ethics committee address [1] 304453 0
Building 14, The Prince Charles Hospital, Rode Road, Chermside, QLD 4032
Ethics committee country [1] 304453 0
Australia
Date submitted for ethics approval [1] 304453 0
22/12/2015
Approval date [1] 304453 0
28/01/2016
Ethics approval number [1] 304453 0
HREC/15/QPCH/256

Summary
Brief summary
The aim of this research is to develop a mobile based multidisciplinary virtual clinic based on the existing platform (MoTER) and to investigate the impact of such a clinic on health outcomes and clinical management of patients with HF.
The primary hypothesis is that participants in the MoTER-HF arm will have satisfying uptake and adherence to the intervention.

Patients in the MoTER-HF arm will have access to the mobile based intervention
program which consists of educational materials, self-management interventions and healthcare providers' feedback for the period of three months.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96998 0
Dr Scott McKenzie
Address 96998 0
The Prince Charles Hospital I Northside Clinical Unit , The University of Queensland, Faculty of Medicine, Rode Road, Chermside, QLD 4032
Country 96998 0
Australia
Phone 96998 0
+61 7 3139 5566
Fax 96998 0
+61 7 3139 4426
Email 96998 0
[email protected]
Contact person for public queries
Name 96999 0
Mrs Nazli Bashi
Address 96999 0
The Australian E-Health Research Center
Level 5, UQ Health Sciences Building 901/16
Royal Brisbane and Women's Hospital, Herston, QLD 4029
Country 96999 0
Australia
Phone 96999 0
+61 732533611
Fax 96999 0
Email 96999 0
[email protected]
Contact person for scientific queries
Name 97000 0
Mrs Nazli Bashi
Address 97000 0
The Australian E-Health Research Center
Level 5, UQ Health Sciences Building 901/16
Royal Brisbane and Women's Hospital, Herston, QLD 4029
Country 97000 0
Australia
Phone 97000 0
+61 732533611
Fax 97000 0
Email 97000 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5165Ethical approval    378485-(Uploaded-30-09-2019-12-56-13)-Study-related document.pdf
5166Study protocol    378485-(Uploaded-30-09-2019-12-56-41)-Study-related document.docx



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.