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Program Using a Mobile Application Versus Telephone Advice on Patients at Risk of Coronary Heart Disease : a Pilot RCT

NCT04054258 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-07-16

No results posted yet for this study

Summary

Topic: Effectiveness of the nurse-led support programme using a mobile application versus telephone advice on patients at risk of coronary heart disease - a randomized controlled trial

Aims: The study aims to compare the effects of a nurse-led support programme using a mobile application versus telephone advice on patients at risk of coronary heart disease who have been discharged from the emergency department (ED).

Methods: A multi-centre, single-blinded, randomized controlled trial will be conducted. 80 patients diagnosed as being at risk of CHD, able to use a smart phone, and who have been discharged from the ED will be randomized into the App Support Programme (ASP) group or the Telephone Support (TS) group. All participants will receive standard medical and nursing care on discharge. The ASP group will receive an app whereas the TS group will receive telephone support provided by the nurse for 20 minutes bi-weekly.

The self-developed mobile app will support clients in managing their health problems and lifestyle. It is comprised of: (1) a knowledge health platform, (2) a membership area for individual health measures and exercise records, (3) a Chest Pain - Things to Do List, and (4) an individual reminder and measure feedback system.

Health outcomes will be collected at baseline (T0), 1 month (T1), 3 months (T2). The primary outcome is Self-efficacy and self-management behavior. Secondary outcomes are: (i) ED and hospitalization frequency; (ii) Physiological health profile and cardiovascular functional endurance; (3) total amount of exercise; (4) perceived stress level; (5) health literacy; and (6) quality of life.

Data analysis: A Generalized Estimating Equations model will be used to assess differential changes in all outcome variables.

Conditions

  • Coronary Heart Disease

Interventions

DEVICE

App support Programme (ASP) group

All subjects will continue their usual care with prescribed medical treatments, ED nursing advice, and follow-ups as indicated. In addition to the above usual care, bi-weekly 20 minutes telephone follow ups will be provided by a trained research nurse (B) up to 3 months. Patients can ask related health problems if any. The nurse will address their problem by providing advices or refer them to the ED follow up clinic if the problems cannot be solved by the nurse.

Sponsors & Collaborators

  • Tuen Mun Hospital

    collaborator OTHER_GOV

  • The Hong Kong Polytechnic University

    lead OTHER

Principal Investigators

  • Shuk Yee Ko · Tuen Mun Hospital

  • Lip Yip Lee · Tin Shui Wai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2021-04-30
Completion
2021-09-30

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04054258 on ClinicalTrials.gov