EMPOWERing Patients With Chronic Diseases Through Smartphone App, Health Coaching and Shared Decision Making

Singapore Health Services (SingHealth)

Status: Active, not recruiting

Conditions: Hypertension; Diabetes Mellitus, Type 2

Treatments: Behavioral: Nudge, health coaching and shared decision-making

Study type: Interventional

Funder types: Other

Identifiers

NCT05486390

202203-00046

Details and patient eligibility

About

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.

Enrollment: 320 patients

Sex: All

Ages: 21 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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320 participants in 2 patient groups

Intervention

Experimental group

Treatment:

Behavioral: Nudge, health coaching and shared decision-making

Control

No Intervention group