Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001213134
Ethics application status
Approved
Date submitted
9/08/2019
Date registered
2/09/2019
Date last updated
18/09/2019
Date data sharing statement initially provided
2/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Mobile Phone Text messaging Intervention for Blood Pressure Control (TEXT4BP)
Scientific title
Feasibility study on Effectiveness and Acceptability of Mobile Phone Text Messaging Intervention for Improving Treatment Adherence and Lifestyle Modification for Blood Pressure Control among Hypertensive Patients in Nepal (TEXT4BP): A Randomized Control Trial
Secondary ID [1] 298846 0
Nil Known
Universal Trial Number (UTN)
U1111-1237-5908
Trial acronym
TEXT4BP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 313800 0
Condition category
Condition code
Cardiovascular 312212 312212 0 0
Hypertension
Public Health 312218 312218 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TEXT4BP: Three-month intervention consisting of mobile phone text messages send thrice a week from provider to patient (unidirectional) in the Nepali language. Messages were developed following formative research, using the COM-B Model to identify barriers and facilitators of treatment and blood pressure control among hypertensive patients seeking treatment at a hospital in Kathmandu Nepal. The content of the text message intervention is developed to align with selected behaviour change techniques (BCTs) information and targets information on hypertension and its complications, taking medication, diet (low sodium, low fat) and physical activity (exercise), quitting/reduction of smoking and alcohol. Hypertensive patients in the intervention arm would receive the text messages in the specified frequency and time using a Bulk SMS provider. Unidirectional text messages will be sent thrice a week for three months so there will be a total of 36-40 text messages. The average length of the text message would be 160 characters. There will be some personalisation of text messages based on smoking and alcoholism status. For example, only smokers will receive messages regarding Cessation/ reduction of smoking.
The intervention uses text messages as most participants may only access the text. The messages were developed to address behaviour change techniques (BCT) identified in the formative research. We will collect data on text messages delivered and viewed through the SMS provider platform.
The text messages include advice on aspects of behaviour change, for example, physical activity levels based on accepted norms. We will collect data on these behaviours at baseline and end of the study.

Intervention code [1] 315111 0
Lifestyle
Intervention code [2] 315112 0
Prevention
Intervention code [3] 315291 0
Behaviour
Comparator / control treatment
The controls arm will receive the usual care according to the hospital protocol. At the end of the study (after three months), they will receive pamphlets containing information about hypertension and its treatment and recommended behavior modification information according to existing protocols.
Control group
Active

Outcomes
Primary outcome [1] 320859 0
Systolic and Diastolic Blood pressure. Blood pressure would be measured using the digital blood pressure monitor (Kenze BPM OS- 30) following the 2018 ESC/ESH Guidelines for the office blood pressure measurement. Before taking the measurements, participants will be asked to sit comfortably and rest for 5 minutes with legs uncrossed. Three readings of the systolic and diastolic blood pressure will be measured 1-2 min apart. The average of the last two reading would be calculated. 
Timepoint [1] 320859 0
Baseline and after 12 weeks (Three months) of intervention commencement
Secondary outcome [1] 373111 0
Adherence to antihypertensive medication measured using Hill and Bone Compliance to antihypertensive therapy scale, It comprises 14 questions which contain sub-scales: reduced sodium intake (three items), appointment-keeping (two items), and medication-taking ( (nine items).
Timepoint [1] 373111 0
Baseline and after 12 weeks (three months) of commencement of the intervention
Secondary outcome [2] 373112 0
Medication adherence self-efficacy measured using medication adherence self-efficacy scale for hypertensive patients consisting of 13 items.
Timepoint [2] 373112 0
Baseline and after 12 weeks of intervention commencement
Secondary outcome [3] 373116 0
Intake of salt measured by standard adapted questionnaire of the WHO STEPS survey.
Timepoint [3] 373116 0
Baseline and after 12 weeks of intervention commencement
Secondary outcome [4] 373880 0
Physical activity measured by standard adapted questionnaire of WHO STEPS survey
Timepoint [4] 373880 0
Baseline and after 12 weeks of intervention commencement

Eligibility
Key inclusion criteria
1. Participants between the ages of 18-69 years of age.

2. Patients diagnosed with hypertension and have been stabilized with a medication regime based on Joint National Committee VII criteria

3. Participants who or whose family have a mobile phone and able to read a text message (SMS) by themselves or with the help of family members.

4. Participants who are likely to be in the study area during the period of intervention.
Minimum age
18 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded who

i) Have a severe mental illness or cognitive impairment or any physical disability.
ii) Have severe illness needed immediate care.
iii) Are pregnant or post-partum.
iv) Are residing in hospitals, prisons, nursing homes, and other institutions

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The random allocation will take place after baseline data is collected and provider and researchers collecting data at baseline will be blinded of allocation status. Sealed opaque envelopes will be used for assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random sequence would be generated using the online website Random.org.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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
Since this is the feasibility study, the sample size was not determined based on inference testing given the pilot design of the study. Approximately 100 patients will be enrolled in the intervention arm and 100 in the control arm.
We would perform an intention to treat analysis as well as an as-treated analysis for the endpoint of blood pressure control and medication adherence from baseline to the end of three months. We would compare the mean pre-vs post-BP in the intervention and control groups using logistic regression (logit model). Wald test would be used in Proc logistic while testing for a difference in the control group to the intervention group after controlling for a patient starting blood pressure. Before After Control Impact (BACI) design would be used for comparing the changes in behavioral variables like medication adherence, medication adherence self-efficacy, salt intake, and physical activity. An analysis of variance (ANOVA) will be used to an interaction between the outcomes of control/treatment samples and before/after samples.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/09/2019
Actual
9/09/2019
Date of last participant enrolment
Anticipated
30/11/2019
Actual
Date of last data collection
Anticipated
29/02/2020
Actual
Sample size
Target
200
Accrual to date
22
Final
Recruitment outside Australia
Country [1] 21722 0
Nepal
State/province [1] 21722 0
3

Funding & Sponsors
Funding source category [1] 303394 0
Government body
Name [1] 303394 0
Department of Foreign Affairs and Trade
Country [1] 303394 0
Australia
Primary sponsor type
Individual
Name
Buna Bhandari Bhattarai
Address
School of Public Health and Community Medicine
Faculty of Medicine
The University of New South Wales
2052, NSW, Sydney, Australia
Country
Australia
Secondary sponsor category [1] 303459 0
None
Name [1] 303459 0
Address [1] 303459 0
Country [1] 303459 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303923 0
The University of New South Wales Human Research Ethics Committee B
Ethics committee address [1] 303923 0
Ethics committee country [1] 303923 0
Australia
Date submitted for ethics approval [1] 303923 0
06/05/2019
Approval date [1] 303923 0
15/07/2019
Ethics approval number [1] 303923 0
HC190357
Ethics committee name [2] 303941 0
Kathmandu Medical College and Teaching Hospital Institutional Review Committee
Ethics committee address [2] 303941 0
Ethics committee country [2] 303941 0
Nepal
Date submitted for ethics approval [2] 303941 0
15/04/2019
Approval date [2] 303941 0
03/05/2019
Ethics approval number [2] 303941 0
030520192
Ethics committee name [3] 304281 0
Government of Nepal, Nepal Health Research Council
Ethics committee address [3] 304281 0
Ethics committee country [3] 304281 0
Nepal
Date submitted for ethics approval [3] 304281 0
15/05/2019
Approval date [3] 304281 0
04/09/2019
Ethics approval number [3] 304281 0
302/2019

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

Contacts
Principal investigator
Name 95266 0
Mrs Buna Bhandari Bhattarai
Address 95266 0
School of Public Health and Community Medicine
Faculty of Medicine
The University of New South wales
Kensington, Sydney, NSW 2052
Country 95266 0
Australia
Phone 95266 0
+61 410348519
Fax 95266 0
Email 95266 0
[email protected]
Contact person for public queries
Name 95267 0
Buna Bhandari Bhattarai
Address 95267 0
School of Public Health and Community Medicine
Faculty of Medicine
The University of New South wales
Kensington, Sydney, NSW 2052
Country 95267 0
Australia
Phone 95267 0
+61410348519
Fax 95267 0
Email 95267 0
[email protected]
Contact person for scientific queries
Name 95268 0
Buna Bhandari Bhattarai
Address 95268 0
School of Public Health and Community Medicine
Faculty of Medicine
The University of New South wales
Kensington, Sydney, NSW 2052
Country 95268 0
Australia
Phone 95268 0
+61 410348519
Fax 95268 0
Email 95268 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?

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
SourceTitleYear of PublicationDOI
EmbaseTheory-based mobile phone text messaging intervention for blood pressure control (TEXT4BP) among hypertensive patients in Nepal: Study protocol for a feasibility randomised controlled trial.2020https://dx.doi.org/10.1136/bmjopen-2020-040799
EmbaseEffectiveness and Acceptability of a Mobile Phone Text Messaging Intervention to Improve Blood Pressure Control (TEXT4BP) among Patients with Hypertension in Nepal: A Feasibility Randomised Controlled Trial.2022https://dx.doi.org/10.5334/GH.1103
N.B. These documents automatically identified may not have been verified by the study sponsor.