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

NCT05486390 | Active Not Recruiting

• 1 other identifier: 202203-00046
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus, Type 2; Hypertension

Keywords

Nudge; Wearable; Behavioural change

Outcome Measures

Primary Outcomes (1)

• HbA1c

  HbA1c over 9 months

  9 months

Secondary Outcomes (7)

• Systolic blood pressure

  9 months

• Physical activity as measured by number of steps

  9 months

• Physical activity as measured by moderate to vigorous active minutes

  9 months

• Patient activation score as measured by patient activation measure

  9 months

• Medication adherence as measured by Voils Scale

  9 months

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Nudge, health coaching and shared decision-making

Control

NO INTERVENTION

Interventions

Nudge, health coaching and shared decision-making BEHAVIORAL

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 : 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.

Intervention

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Singapore General Hospital: lead
• SingHealth Polyclinics: collaborator
• National University of Singapore: collaborator
• Duke-NUS Graduate Medical School: collaborator

Study Sites (3)

SingHealth Polyclinic (Bedok)

Singapore, Singapore

Location

SingHealth Polyclinic (Punggol)

Singapore, Singapore

Location

SingHealth Polyclinic (Tampines)

Singapore, Singapore

Location

Related Publications (1)

• 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.

  PMID: 38408067 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 3, 2022
• Study Start: February 17, 2023
• Primary Completion: August 1, 2024
• Study Completion: May 1, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (3)