Clinical trial NCT04968067: A Programme Using a Mobile Application Versus Phone Advice on Patients at Risk of Coronary Heart Disease - A RCT
Official title: Effectiveness of the Professional-led Support Programme Using a Mobile Application Versus Phone Advice on Patients at Risk of Coronary Heart Disease - A Randomized Controlled Trial (Phase 2)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease
Keywords: e-health
nursing telephone advice
exercise
risk factors
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Tung Wah College
First posted: 2021-07-20
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will employ a prospective randomized controlled trial (RCT) with two arms, namely, the App group, NTA (nursing telephone advice) group. This design is guided by the CONSORT checklist
Primary purpose: SUPPORTIVE_CARE

Brief summary: It aims to compare the effects of a professional -led support programme using a mobile application versus telephone advice on clients at risk of coronary heart disease. A multi-centre, single-blinded, randomized controlled trial will be conducted. 168 Clients who are at risk of coronary heart disease (CHD), able to use a smart phone will be randomized into the App Support group (App group) or the Nursing Telephone advice (NTA) group . All participants will receive same nursing educational briefing related to CHD. The App Group will additional receive an app use to support their self care whereas the NTA group will receive nursing telephone advice for 20 minutes monthly.

Health outcomes will be collected at baseline (T0), 1 months (T1), 3 months (T2). Data analysis will be conducted using a Generalized Estimating Equations model to assess differential changes in all outcome variables.

Detailed description: The aim of this study is to test the effects of a professional-led support programme for clients who are at risk of developing CHD on outcomes of total exercise, self-efficacy and self-management behavior, emergency department attendance and hospitalizations, CHD risk factor profile, and quality of life.

Over 3 months, the investigators will examine the effect on the App group as compared to the NTA group and the control group of: Total amount of exercise (primary outcome) and secondary outcomes:1) Self-efficacy and self-management behavior; 2)Emergency department attendance and hospitalization frequency;3) CHD risk factor profile (smoking, blood pressure, body mass index, blood lipid level);4) Cardiovascular functional endurance;5)Perceived stress ; and 6) Quality of life.

A prospective multi-Centre, parallel, randomized controlled trial (RCT) with two arms - an app support programme (App) group vs a Nursing Telephone advice (NTA) group and a control group - will be adopted. The RCT method follow CONSORT 2010 guideline. 168 subjects will be required (n=84 each group). Subject recruitment will likely take about 14 months.

Intervention protocol: 168 Clients who are at risk of coronary heart disease (CHD), able to use a smart phone will be randomized into the App Support group (App group) or the Nursing Telephone advice (NTA) group. All eligible participants will receive same nursing educational briefing related to CHD. The App Group will additionally receive an app use to support their self -care whereas the NTA group will receive a leaflet and a monthly nursing telephone advice ( about 20 minutes per call. The duration of intervention will be about 3 months. Health outcomes will be collected by research assistant at baseline (T0), 1 months (T1), 3 months (T2) at the community Centre or research Centre. Data analysis will be conducted using SPSS and a Generalized Estimating Equations model to assess differential changes in all outcome variables. All the tests will be two-sided and a p-value of \<0.05 will be considered statistically significant.

Ethical approval and permission will be sought from the study university and the selected community centres. RCT registration has been obtained from the ClinicalTrials.gov Protocol Registration system (https://clinicaltrials.gov/).

Eligibility criteria: The study's subject inclusion criteria will be:

1. Chinese adults with coronary cardiac risk factors (at least two from iv );
2. those able to perform a brisk walking exercise; and
3. those who possess a smart phone and are able to use it.
4. Coronary heart disease risk factors:

   * current regular smoker,
   * over 50 years of age;
   * has a medical diagnosis of diabetes or hypertension;
   * has a family history of ischaemic heart disease or hyperlipaemia ;
   * has hyperlipidaemia or is regularly taking drugs for hyperlipidaemia;
   * is obese (BMI\>25);
   * has had a Percutaneous Coronary Intervention performed;
   * was diagnosed with stable angina and prescribed with Trinitroglycerin (TNG) drugs.

The exclusion criteria will be those :

1. with mental, visual, hearing, or cognitive impairments as a result of which they are unable to perform a brisk walking exercise or communicate using a smart phone;
2. on a waiting list for cardiac angiography within 6 months, and
3. has medical diagnosis of unstable angina.

Primary outcomes:
measure: Change of total physical exercise: the Godin-Shepherd Leisure Time Physical Activity Questionnaire.
timeFrame: baseline, 3 months
Secondary outcomes:
measure: Change of Self-efficacy in illness management
timeFrame: baseline, 3 months
measure: Change of blood pressure
timeFrame: baseline, 3 months
measure: Change of cardiovascular endurance test
timeFrame: baseline, 3 months
measure: Change of total physical exercise
timeFrame: baseline, 3 months
measure: Change of perceived stress scale (PSS-10)
timeFrame: baseline, 3 months
measure: Change of Quality of Life:ED-5D
timeFrame: baseline, 3 months
measure: Hospitalization frequency
timeFrame: 3 months
measure: change of body weight
timeFrame: baseline, 3 months
measure: change in LDL cholesterol
timeFrame: baseline, 3 months
measure: Change in HDL cholestero
timeFrame: baseline, 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Wan chai Methodist Centre for the Seniors
Study officials:
affiliation: Tung Wah College
name: Eliza ML wong, PhD
role: PRINCIPAL_INVESTIGATOR
References: