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

NCT04054258 | Unknown

• 1 other identifier: 16172411
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

coronary heart disease; e-health; self-efficacy

Outcome Measures

Primary Outcomes (1)

• Change of Self-efficacy and self-management behaviour

  Self-efficacy and self-management behaviour can be reflected by a total sum of score of a subscale of Self-efficacy in illness management (six items) and communication with healthcare professionals (three items) of the Self-Management Behaviour Questionnaire

  Baseline, 3 months

Secondary Outcomes (9)

• Blood pressure

  3 months

• Change of cardiovascular endurance test

  Baseline, 3 months

• Change of total physical exercise

  Baseline, 3 months

• Change of perceived stress scale (PSS-10)

  Baseline, 3 months

• Change of Health literacy

  Baseline, 3 months

Other Outcomes (3)

• Change in body weight

  baseline 3 months

• Change in LDL cholesterol

  baseline, 3 months

• Change in HDL cholesterol

  baseline, 3 months

Study Arms (2)

App support programme group

EXPERIMENTAL

In addition to the usual care, the participant and one family member will receive a CHD app and a briefing from a trained research nurse (A). The reason to invite an additional family member to install the app is to ensure that he/she can be informed automatically when the patient presses an icon during a chest pain attack. The patient may be too stressed during an angina attack and may not be able to follow the 'Things to Do List' quickly. In addition, automatic reminders of the individual's medication times and follow-up times will be pre-set in the app for individual use.

Device: App support Programme (ASP) group

Telephone support group

ACTIVE COMPARATOR

In addition to the above usual care, bi-weekly 20-minute telephone follow-ups will be provided by a trained research nurse (B) for up to 3 months. Patients can ask about related health problems if any. The nurse will address their problem by providing advice or referring them to the ED follow-up clinic. The team has set up a telephone advice guide to support the research nurse in giving phone advice.

Device: App support Programme (ASP) group

Interventions

App support Programme (ASP) group DEVICE

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.

Also known as: Telephone support group

App support programme group; Telephone support group

Eligibility Criteria

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

You may qualify if:

• Chinese adults with a medical diagnosis of at-risk CHD disorders, including those with angina but no change in ST elevation on ECG and an acceptable troponin level 4 and those discharged from an ED; or those have at least two CHD risk factors : i) current regular smoker, ii) over 50 years of age; iii) has a medical diagnosis of diabetes or hypertension; iv) has a family history of ischaemic heart disease or hyperlipaedmia ;v) has hyperlipidaemia or is regularly taking drugs for hyperlipidaemia; vi) is obese (BMI\>25); vii) has had a Percutaneous Coronary Intervention performed; and viii) was diagnosed with stable angina and prescribed with TNG drugs
• Those able to perform a brisk walking exercise and who have passed the 3-minute walking test
• Those who possess a smart phone and are able to use it.

You may not qualify if:

• Those with physical, mental, visual, or cognitive impairments for which they are undergoing regular medical follow-ups and treatment
• Those with musculoskeletal disorders or other disabling diseases that may limit the practice of any walking exercise.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Tuen Mun Hospital: collaborator

Study Sites (2)

Tin Shui Wai Hospital

Hong Kong, Hong Kong

ACTIVE NOT RECRUITING

Tuen Mun Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (21)

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Related Links

• World Health Organization. Cardiovascular diseases (CVDs). 2017.
• Department of Health, The Hong Kong Special Administrative Region. Number of Deaths by Leading Causes of Death, 2001 - 2017. Department of Health, The Hong Kong Special Administrative Region

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Shuk Yee Ko

  Tuen Mun Hospital

  PRINCIPAL INVESTIGATOR

• Lip Yip Lee

  Tin Shui Wai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mi Ling ML Wong

CONTACT

2766-6544; eliza.wong@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomization will be 1:1 to each treatment arm and will be stratified by the center. Block randomization with varying block sizes will be used to recruit equal numbers to each arm. A computer-generated randomizer will be used to generate the random allocation list. A statistician (DL) from the research team who is not involved in recruiting patients or collecting data will perform the randomization. Each eligible subject will be assigned a number generated by the computer. Subjects will be randomly allocated to different groups according to their number. In this study, the statisticians, outcome assessors, and research assistants assigned to perform data inputting will be blinded to the allocation sequence. Given the type of intervention, however, the intervention will be unmarked to the participants and the research nurse performing the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A prospective multi-center, parallel, randomized controlled trial with two arms: app support (ASP) group v.s. a telephone support (TS) group. Two-Armed study design may yield reliable evidence about the interventional use of app support v.s. telephone support, and will allow us to directly investigate the cause and effects. This design is guided by the CONSORT checklist.

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 13, 2019
• Study Start: October 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: September 30, 2021
• Last Updated: July 16, 2021

Record last verified: 2021-07

Locations

HK (2)