Clinical trial NCT05486390: EMPOWERing Patients With Chronic Diseases Through Smartphone App, Health Coaching and Shared Decision Making
Official title: EMPOWERing Patients With Chronic Diseases Through Smartphone App, Health Coaching and Shared Decision Making
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Hypertension
Keywords: Nudge
Wearable
Behavioural change
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: SingHealth Polyclinics
name: National University of Singapore
name: Duke-NUS Graduate Medical School
First posted: 2022-08-03
Enrollment: 320
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Aged 21 years old and above
2. Have been diagnosed with diabetes at time of recruitment
3. Most recent glycated haemoglobin (HbA1c) ≥ 7.0%
4. Systolic blood pressure≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg on two or more prior visits, physician-diagnosed hypertension, or on antihypertensive medication
5. Physically able to exercise
6. Literate in English
7. Agreeable to be monitored by EMPOWER and/or Fitbit apps
8. Able to conform to monitoring schedule

Exclusion Criteria:

1. On bolus insulin treatment
2. Require assistance with basic activities of daily living (BADL)
3. Have planned major operation or surgical procedure within next 9 months
4. Cognitively impaired (scored ≥ 6 on the Abbreviated Mental Test)

Primary outcomes:
measure: HbA1c
timeFrame: 9 months
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: 9 months
measure: Physical activity as measured by number of steps
timeFrame: 9 months
measure: Physical activity as measured by moderate to vigorous active minutes
timeFrame: 9 months
measure: Patient activation score as measured by patient activation measure
timeFrame: 9 months
measure: Medication adherence as measured by Voils Scale
timeFrame: 9 months
measure: Quality of life as measured by EQ-5D-5L
timeFrame: 9 months
measure: Healthcare cost
timeFrame: 9 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: SingHealth Polyclinic (Bedok)
city: Singapore
country: Singapore
facility: SingHealth Polyclinic (Punggol)
city: Singapore
country: Singapore
facility: SingHealth Polyclinic (Tampines)
Study officials:
References: