Diabetes Mellitus, Type 2NCT05486390
EMPOWERing Patients With Chronic Diseases Through Smartphone App, Health Coaching and Shared Decision Making
A study testing Nudge, health coaching and shared decision-making in people with Diabetes Mellitus, Type 2 and Hypertension, run by Singapore General Hospital at 3 sites in Singapore.
Trial summary
Chronic diseases are the leading cause of deaths in Singapore. The rising prevalence in chronic diseases with age and Singapore's rapidly aging population calls for new models of care to effectively prevent the onset and delay the progression of these diseases. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypertension
- What is being tested?
- Nudge, health coaching and shared decision-making
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 3 sitesSingapore
- Study dates
- 17 Feb 2023to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 21 years old and above
- Have been diagnosed with diabetes at time of recruitment
- Most recent glycated haemoglobin (HbA1c) ≥ 7.0%
- Systolic blood pressure≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg on two or more prior visits, physician-diagnosed hypertension, or on antihypertensive medication
- Physically able to exercise
- Literate in English
- Agreeable to be monitored by EMPOWER and/or Fitbit apps
- Able to conform to monitoring schedule
Who cannot join
- On bolus insulin treatment
- Require assistance with basic activities of daily living (BADL)
- Have planned major operation or surgical procedure within next 9 months
- Cognitively impaired (scored ≥ 6 on the Abbreviated Mental Test)
Trial locations and contacts
3 sites in 1 country.
Singapore3 sites
SingHealth Polyclinic (Bedok)
Singapore
SingHealth Polyclinic (Punggol)
Singapore
SingHealth Polyclinic (Tampines)
Singapore
About this study
Chronic diseases are the leading cause of deaths in Singapore. The rising prevalence in chronic diseases with age and Singapore's rapidly aging population calls for new models of care to effectively prevent the onset and delay the progression of these diseases. Advancement in medical technology has offered new innovations that aid healthcare systems in coping with the rapid rising in healthcare needs. These include mobile applications, wearable technologies and machine learning-derived personalized behaviorial interventions. The overall goal of the project is to improve health outcomes in chronic disease patients through delivering targeted nudges via mobile application and wearable to sustain behavioral change. Our overall objective is to design, develop, and evaluate an adaptive intervention platform on wearable devices and shared decision-making during consultations for patients with diabetes and hypertension. Our aim for this study is to assess the clinical effectiveness of real-time personalized educational and behavioural interventions delivered through wearable (Fitbit) and an integrative mobile application in improving patient glycaemic control measured using HbA1c over 9 months. Secondary outcomes will include change in systolic blood pressure, quality of life (QoL), patient activation, medication adherence, physical activity level, diet, direct healthcare cost and indirect healthcare cost over 9 months. We will conduct a randomized controlled trial among patients with comorbid diabetes and hypertension. This proposal aims to develop sustainable and cost-effective behavioural change among patients with comorbid diabetes and hypertension through patient empowerment and targeted chronic disease care.
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Being tested
- Nudge, health coaching and shared decision-making
- Keywords
- Nudge, Wearable, Behavioural change
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nudge, health coaching and shared decision-makingBehavioural
The EMPOWER app aims to nudge the participant towards successful self-management of their diabetes condition by encouraging and reinforcing positive lifestyle behaviors in 3 main aspects - diet, physical activity, medication adherence. Notifications included content based on behavioural change technique including feedback on performance, positive reinforcement, and prompts to self-monitor. Each notification focused on a single behaviour (physical activity, medication adherence or diet).
The participants in the intervention group will also interact with health coach throughout the study duration. In this study, the health coach will be responsible for the following roles :
- Goal setting and action plan
- After-visit summary
A report card summarizing the lifestyle behaviour, goals will be made available to facilitate shared decision making.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Nudge, health coaching and shared decision-making |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
HbA1c over 9 months
Measured: 9 months
Secondary outcomes (7)
Systolic blood pressure
Systolic blood pressure over 9 months
Measured: 9 months
Physical activity as measured by number of steps
Physical activity over 9 months
Measured: 9 months
Physical activity as measured by moderate to vigorous active minutes
Physical activity over 9 months
Measured: 9 months
Patient activation score as measured by patient activation measure
Difference in patient activation score between intervention and control over 9 months
Measured: 9 months
Medication adherence as measured by Voils Scale
Difference in medication adherence between intervention and control over 9 months
Measured: 9 months
Quality of life as measured by EQ-5D-5L
Difference in quality of life between intervention and control over 9 months
Measured: 9 months
Healthcare cost
Healthcare cost over 9 months
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start17 Feb 2023
- Primary completionAug 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SingHealth Polyclinics, National University of Singapore, Duke-NUS Graduate Medical School
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486390
- Sponsor's protocol ID
- 202203-00046
- Status last verified
- Apr 2024
- First submitted
- 1 Aug 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kwan YH, Yoon S, Tai BC, Tan CS, Phang JK, Tan WB, Tan NC, Tan CYL, Koot D, Quah YL, Teo HH, Low LL. Empowering patients with comorbid diabetes and hypertension through a multi-component intervention of mobile app, health coaching and shared decision-making: Protocol for an effectiveness-implementation of randomised controlled trial. PLoS One. 2024 Feb 26;19(2):e0296338. doi: 10.1371/journal.pone.0296338. eCollection 2024.
PubMed 38408067
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMPOWERing Patients With Chronic Diseases Through Smartphone App, Health Coaching and Shared Decision Making
- ClinicalTrials.gov ID
- NCT05486390
- Acronym / sponsor ID
- 202203-00046
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Keywords
- Nudge, Wearable, Behavioural change
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- SingHealth Polyclinics, National University of Singapore, Duke-NUS Graduate Medical School
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic diseases are the leading cause of deaths in Singapore. The rising prevalence in chronic diseases with age and Singapore's rapidly aging population calls for new models of care to effectively prevent the onset and delay the progression of these diseases. Advancement in medical technology has offered new innovations that aid healthcare systems in coping with the rapid rising in healthcare needs. These include mobile applications, wearable technologies and machine learning-derived personalized behaviorial interventions. The overall goal of the project is to improve health outcomes in chronic disease patients through delivering targeted nudges via mobile application and wearable to sustain behavioral change. Our overall objective is to design, develop, and evaluate an adaptive intervention platform on wearable devices and shared decision-making during consultations for patients with diabetes and hypertension. Our aim for this study is to assess the clinical effectiveness of real-time personalized educational and behavioural interventions delivered through wearable (Fitbit) and an integrative mobile application in improving patient glycaemic control measured using HbA1c over 9 months. Secondary outcomes will include change in systolic blood pressure, quality of life (QoL), patient activation, medication adherence, physical activity level, diet, direct healthcare cost and indirect healthcare cost over 9 months. We will conduct a randomized controlled trial among patients with comorbid diabetes and hypertension. This proposal aims to develop sustainable and cost-effective behavioural change among patients with comorbid diabetes and hypertension through patient empowerment and targeted chronic disease care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Nudge, health coaching and shared decision-making |
| Control | No intervention | – |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 21 years old and above
- Have been diagnosed with diabetes at time of recruitment
- Most recent glycated haemoglobin (HbA1c) ≥ 7.0%
- Systolic blood pressure≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg on two or more prior visits, physician-diagnosed hypertension, or on antihypertensive medication
- Physically able to exercise
Key exclusion criteria (4 listed)
- On bolus insulin treatment
- Require assistance with basic activities of daily living (BADL)
- Have planned major operation or surgical procedure within next 9 months
- Cognitively impaired (scored ≥ 6 on the Abbreviated Mental Test)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nudge, health coaching and shared decision-makingThe EMPOWER app aims to nudge the participant towards successful self-management of their diabetes condition by encouraging and reinforcing positive lifestyle behaviors in 3 main aspects - diet, physical activity, medication adherence. Notifications included content based on behavioural change technique including feedback on performance, positive reinforcement, and prompts to self-monitor. Each notification focused on a single behaviour (physical activity, medication adherence or diet). The participants in the intervention group will also interact with health coach throughout the study duration. In this study, the health coach will be responsible for the following roles : 1. Goal setting and action plan 2. After-visit summary A report card summarizing the lifestyle behaviour, goals will be made available to facilitate shared decision making. | Behavioural | Intervention |
Primary outcome
HbA1c
Time frame: 9 months
HbA1c over 9 months
7 secondary outcomes
Systolic blood pressure
Time frame: 9 months
Physical activity as measured by number of steps
Time frame: 9 months
Physical activity as measured by moderate to vigorous active minutes
Time frame: 9 months
Patient activation score as measured by patient activation measure
Time frame: 9 months
Medication adherence as measured by Voils Scale
Time frame: 9 months
Quality of life as measured by EQ-5D-5L
Time frame: 9 months
Healthcare cost
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Derived from this study: PubMed 38408067Kwan YH, Yoon S, Tai BC, Tan CS, Phang JK, Tan WB, Tan NC, Tan CYL, Koot D, Quah YL, Teo HH, Low LL. Empowering patients with comorbid diabetes and hypertension through a multi-component intervention of mobile app, health coaching and shared decision-making: Protocol for an effectiveness-implementation of randomised controlled trial. PLoS One. 2024 Feb 26;19(2):e0296338. doi: 10.1371/journal.pone.0296338. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nudge, health coaching and shared decision-making in people with Diabetes Mellitus, Type 2 and Hypertension, run by Singapore General Hospital at 3 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05486390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.