Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000104156
Ethics application status
Approved
Date submitted
19/01/2019
Date registered
24/01/2019
Date last updated
29/06/2021
Date data sharing statement initially provided
24/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effectiveness of a Personalised Digital Health Intervention (Naluri) on Self-Care Behaviours and Quality of Life Outcomes among Cardiac Patients at the Malaysian National Heart Institute: A Randomized Controlled Trial
Scientific title
The Effectiveness of a Personalised Digital Health Intervention (Naluri) on Self-Care Behaviours and Quality of Life Outcomes among Cardiac Patients at the Malaysian National Heart Institute: A Randomized Controlled Trial
Secondary ID [1] 297080 0
Nil known
Universal Trial Number (UTN)
U1111-1226-7768
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease 311168 0
Condition category
Condition code
Cardiovascular 309788 309788 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will be approached individually and face-to-face by the researcher for consent and to complete a baseline assessment which includes the Adherence to Healthy Lifestyle Questionnaire, Brief Illness Perception Questionnaire (BIPQ), International Physical Activity Questionnaire (IPAQ), Hospital Anxiety and Depression Scale (HADS) and Heart Quality of Life (HeartQOL). Information on basic demographic information will be obtained and height, weight, blood pressure, HbA1c and cholesterol levels will also be measured.

Participants in the intervention group will be requested to download a digital health intervention called Naluri on their smartphone. Participants will be approached individually. Participants are required to engage with the app for 16 weeks. The Naluri app consists of real-time chat with a dedicated health coach and expert coaches such as dietitian, fitness coach, medical advisor, pharmacist and executive coach. There are over 70 daily modules which participants can complete one daily. This series of proprietary daily modules cover topics like mental readiness, diet, exercise, stress management and self-care. There is a food journal feature that allows patients to log their daily food intake and the coaches will comment and suggest healthier alternatives. The thought journal feature encourages participants to log any helpful or unhelpful thoughts and behaviors related to those thoughts. The participants are then guided by the health coach to understand what were the underlying beliefs and emotions behind those unhelpful actions and to learn skills to eventually prevent recurrence of those behaviours.

Participants are encouraged to engage the app at least 5-10 minutes, once a day by using any of the available features of the app - modules, food journal, thought journal, chat channels, progress planner. Participants are expected to complete at least the first 14 modules which looks into the baseline of participant's current diet and exercise behaviours. Subsequent modules will be recommended by the coaches. Each module takes about 5 to 10 minutes to complete. The modules can be divided into three categories - informational (provides information for the participants), self-help/functional (participants learn a practical skill/technique from the module), and assessment (gather useful information for coaches).

Exercises prescribed in the modules include stretching exercises, bodyweight exercises and also identifying daily activities that can be considered as exercise, for example taking the stairs instead of the lift, parking the car further so that participants can walk further to reach the office. The stretching exercises module allows the participant to choose between warm-up or cool down stretching, select the intensity of the stretching and there are short videos on the different types of stretching such as high knees, calf stretch and butt kicks. The bodyweight exercises module consists of a 7-minute simple workout which includes planks, sit-ups, burpees, abs crunches and squats. There are video tutorials to illustrate these different exercises. Participants may choose the level of intensity for these workouts.

Nutritional information includes educating participants on smart choices for carbohydrates, fats, salt, beverages and snacks. The diet modules also teaches participants about eating mindfully and slowly; planning for flexibility (allowing for cheat meals), calculating and meeting daily water intake, healthy food portions and also differentiating between hunger, desire and cravings.

To monitor user’s progress, the Naluri app is linked to a weighing scale which allows the user to track their weight and body fat percentage trends. Naluri’s approach to lasting healthy habit changes is based on one small change or task a day, with regular feedback and coaching. Examples of small changes or tasks can be encouraging participants to limit sugary drinks to only 1 glass per day for a week, or suggesting participants to take at least two flights of stairs everyday for a week. For the following week, participants can be encouraged to improve those behaviour goals.

The first 12-weeks cover daily exercises, improvements to food intake and regular feedback, and the final 4 weeks switches to self-management to get user’s ready to independently take charge of their lifestyle.

To assess and monitor adherence to the app, app analytics allows the researcher to monitor which feature of the app the participants have used everyday. If user is not active, the health coach can send a message which will pop-up as a notification on the participant's smartphone. The app also has a Challenges feature, whereby the participants can set daily/weekly behaviour tasks to do. The app will send reminders of these tasks at the set time and when the participants complete these tasks, they can acknowledge them in the app. The health coach can work together with the participants in setting these tasks.
Intervention code [1] 313402 0
Lifestyle
Comparator / control treatment
Patients in the control group will receive usual care for their cardiovascular health as determined by their doctors, including cardiovascular medication prescription and advice, as well as lifestyle counselling. Usual care includes a session with the doctors on treatment and medication plans, a session with allied healthcare professionals (dietitian/counselors) and also nurses to educate patients on appropriate diet, exercise and stress management for cardiac patients, Lifestyle coaching refers to counseling on diet, exercise and stress management for the patients.
Control group
Active

Outcomes
Primary outcome [1] 318750 0
Change in physical activities as measured using the International Physical Activity Questionnaire (IPAQ)
Timepoint [1] 318750 0
Baseline and at 16 weeks after randomization
Primary outcome [2] 318751 0
Change in diet as measured using the Adherence to Healthy Lifestyle questionnaire
Timepoint [2] 318751 0
Baseline and at 16 weeks after randomization
Secondary outcome [1] 365917 0
Quality of life as measured by HeartQOL
Timepoint [1] 365917 0
Baseline and 16 weeks after randomization
Secondary outcome [2] 365918 0
Mean score of the Hospital Anxiety and Depression Scale (HADS)
Timepoint [2] 365918 0
Baseline and at 16 weeks after randomization
Secondary outcome [3] 365919 0
Composite secondary outcomes consisting of height, weight, blood pressure, HbA1c and cholesterol levels. These will be measured respectively using stadiometers, weighing scales, electronic sphygmomanometers and serum assay.
Timepoint [3] 365919 0
Baseline and at 16 weeks after randomization
Secondary outcome [4] 379424 0
Perception of illness as measured by Brief Illness Perception Questionnaire (BIPQ)
Timepoint [4] 379424 0
Baseline and at 16 weeks after randomization

Eligibility
Key inclusion criteria
• Consent to participate in research
• Have been discharged from the hospital not more than four weeks after diagnosis
• Smart mobile telephone users
• Literate in either English or Malay.
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients who are currently pregnant
• Have end stage liver and kidney disease
• Have a history of cancer undergoing active treatment
• Currently on weight loss medications
• Currently on active psychotropic medications
• Bedridden
• Patients who are already using similar health intervention app
• Patients with life-threathening co-morbidities
• Patients with severe cognitive impairments

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)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
By using G*Power 3.1, it was suggested that a sample size of 41 per group can have 80% power to detect 30% improvement in adherence to healthy lifestyle (Pfaeffli Dale et al., 2015). Assuming about 44% dropout rate (Simblett et al., 2018), sample size is set to 100 per group.

The primary analysis will be unadjusted, following an intention-to-treat principle, in which the participants will be analysed in the group that they were randomised to. If there are clear differences in baseline characteristics between groups, then sensitivity analyses with additional adjustments for baseline characteristics will be performed. Continuous variables will be analysed using independent t-tests and categorical variables using Chi-square tests as appropriate. Mann-Whitney U tests will be used if data are not normally distributed. We will also calculate relative risks, 95% CIs and two-sided p values for both primary and secondary outcomes. We will also perform a sensitivity analysis, in which participants with missing data for medication adherence at the follow-up, for example, patients who withdrew from the study or were loss at follow-up, will be considered non-adherent (non-responder imputation). Prespecified subgroup analyses will be performed for age, sex, level of education, adherent/non-adherent participants at baseline, and Naluri app/usual care. The criterion for statistical significance will be set at a 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2019
Actual
30/01/2019
Date of last participant enrolment
Anticipated
30/06/2020
Actual
24/09/2020
Date of last data collection
Anticipated
30/11/2020
Actual
31/03/2021
Sample size
Target
200
Accrual to date
Final
200
Recruitment outside Australia
Country [1] 21215 0
Malaysia
State/province [1] 21215 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 301647 0
Commercial sector/Industry
Name [1] 301647 0
Naluri Hidup Sdn Bhd
Country [1] 301647 0
Malaysia
Primary sponsor type
Commercial sector/Industry
Name
Naluri Hidup Sdn Bhd
Address
M-2-8 Plaza Damas, 60 Jalan Sri Hartamas 1, Taman Sri Hartamas, 50480 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 301469 0
None
Name [1] 301469 0
None
Address [1] 301469 0
None
Country [1] 301469 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302369 0
Institute Jantung Negara (IJN) Research Ethics Committee
Ethics committee address [1] 302369 0
Ethics committee country [1] 302369 0
Malaysia
Date submitted for ethics approval [1] 302369 0
10/12/2018
Approval date [1] 302369 0
10/01/2019
Ethics approval number [1] 302369 0
IJNREC/243/2018

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

Contacts
Principal investigator
Name 89986 0
Mrs Darlina Hani Fadil Azim
Address 89986 0
Perdana University - Royal College of Surgeons in Ireland School of Medicine 
Suite 9.2, 9th Floor, Wisma Chase Perdana, Changkat Semantan,
Damansara Heights, 50490 Kuala Lumpur, Malaysia.
Country 89986 0
Malaysia
Phone 89986 0
+60389418646
Fax 89986 0
Email 89986 0
[email protected]
Contact person for public queries
Name 89987 0
Darlina Hani Fadil Azim
Address 89987 0
Perdana University - Royal College of Surgeons in Ireland School of Medicine 
Suite 9.2, 9th Floor, Wisma Chase Perdana, Changkat Semantan,
Damansara Heights, 50490 Kuala Lumpur, Malaysia.
Country 89987 0
Malaysia
Phone 89987 0
+60389418646
Fax 89987 0
Email 89987 0
[email protected]
Contact person for scientific queries
Name 89988 0
Darlina Hani Fadil Azim
Address 89988 0
Perdana University - Royal College of Surgeons in Ireland School of Medicine 
Suite 9.2, 9th Floor, Wisma Chase Perdana, Changkat Semantan,
Damansara Heights, 50490 Kuala Lumpur, Malaysia.
Country 89988 0
Malaysia
Phone 89988 0
+60389418646
Fax 89988 0
Email 89988 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
Currently no plans to share the IPD.


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
No additional documents have been identified.