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

July 12, 2021 updated by: Dr Eliza Wong, The Hong Kong Polytechnic University

Effectiveness of the Nurse-led Support Programme Using a Mobile Application Versus Telephone Advice on Patients at Risk of Coronary Heart Disease - a Pilot Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Aims and Hypotheses to be Tested:

This study compares the effects of a nurse-led support programme - an app support programme (ASP) - with telephone support (TS) for patients discharged from the ED who are at risk of developing CHD. We hypothesize that:

Within 3 months, when compared with the TS group clients, clients who participate in the ASP will have:

Primary outcome: Better self-efficacy and self-management behaviour

Secondary outcomes:

  • Less ED attendance and hospitalization frequency;
  • A better physiological health profile (e.g., blood pressure, body mass index, blood cholesterol level, blood triglyceride level, and blood glucose level) and better cardiovascular functional endurance;
  • An increase in the total amount of exercise;
  • A lower perceived stress level; and
  • Better health literacy regarding cardiac care.

Plan of Investigation:

(i)Methods: A prospective multi-center, parallel, randomized controlled trial with two arms - an app support programme (ASP) group vs a telephone support (TS) group - will be adopted. 1. Settings: Data will be collected from an EDs at a regional Hong Kong hospital, namely Tuen Mun Hospital and the community centres. The demographic profile of the residents and the setting and care protocol will be similar, to minimize the cluster effect. Each ED includes a short stay unit and an emergency medical unit (EMW) with about 26 beds. Patients with cardiac disorders account for approximately 25% of all EMW admissions (n=1900 per year) and generally have hypertension or hyperlipidemia and angina 4.

2. Recruitment of subjects: The admission records of all eligible clients with a medical diagnosis of at-risk CHD in the study ED will be screened. Identified patients will be approached by the research assistant (RA1) for further screening and those deemed to be eligible will be invited to join the study. Appendix 2 presents the CONSORT flow diagram of the study.

About 80 potential patients will be approached. Eligible patients who consent to participate in the study and then who submit to the collection of their baseline data will be randomly allocated to either the ASP group or the TS group according to the pre-set randomization sequence. Participants will attend an appointment with a research nurse (A) who has experience in cardiac nursing and specific training in the intervention. Follow-ups will be conducted at 1 month, and 3 months by another RA (2), who will be blinded to the intervention allocation.

Regarding patient recruitment, we estimate that 75% of eligible CHD patients (n=5-7 per week) will agree to join the study at an ED and that at least 8-10 patients will be recruited from both EDs per week. These estimations are based on local departmental statistics and on a previous study that we conducted in a regional ED. 4 We further estimate that 10 weeks will be required to recruit all of the patients required for the study (60 patients). Due to the Covid- 19 situation that subject recruitment is not allowed, we also extend the subject recruitment to community centres..Subject inclusion criteria are the same. Ethical approval has been obtained from the university and the study venues.

3. Follow-up data collection: During the 1-, and 3-month follow-ups, the trained RA (2) and student research assistants (who are master's nursing students), who will be blinded to group allocation, will collect data and perform physical assessments of the participants at the university's research laboratory office. This office has sufficient space and equipment to perform health assessments and laboratory tests. "Item e" shows the facilities in detail. All participants will be asked to complete the questionnaires, place them in an envelope, and hand the envelope to the research assistants.

To ensure the quality of patient recruitment, intervention, and data collection processes, the research team will ensure that the RAs and research nurses are capable of carrying out the proper procedures. All of the research nurses are qualified and experienced in cardiac nursing. They will be provided with specific training workshops by the PI and Co-Is prior to the commencement of the study. One research nurse (A) who is skilled in cardiac nursing and counseling will deliver all of the educational interventions to ensure consistency. Audit procedures will be conducted to ensure the quality and uniformity of the educational intervention. Another research nurse (B) will provide the telephone advice intervention to the TSG. The team will visit the EDs at least once per week during the initial recruitment period. Weekly meetings with research nurses and research assistants will be held to ensure good quality in data collection and to solve any logistical problems.

Data processing and analysis To minimize subject contamination, the different groups will be assigned different follow-up dates. The research assistants who are responsible for collecting data will be blinded to the group allocations. They will receive a briefing and training session on collecting data, taking blood using the finger-stick method, and using the auto blood analyzers. All questionnaires will be distributed to the individual participants, who will be asked to place their own completed questionnaire in a locked box.

Data will be analyzed using SPSS. The intention-to-treat principle will be applied. The baseline characteristics of the groups will be compared using a Chi-square or Fisher's exact test for categorical variables, and a t-test or Mann-Whitney test for continuous variables, to examine the comparability of the groups by randomization. Confounding variables will be accounted for in subsequent analyses. The effectiveness of an e-health programme using the app vs telephone support will be evaluated by comparing the study outcomes using Generalized Estimating Equations (GEE) models. For the primary outcomes of self-efficacy and self-management behavior, two GEE models with an identity link function will be performed. For the two secondary outcome variables that are measured in counts (i.e., ED attendance and the number of hospitalizations), GEE models with a log link function and a Poisson distribution will be performed. For the other secondary outcomes, which are continuous, GEE models with an identity link will be fitted. Significant time by group interactions in the GEE models will support our hypotheses on the effects of the e-health intervention using app support. Descriptive statistics will be used to summarize the level of satisfaction with the use of the app at T1 to T3 in the intervention group, and a GEE model will be used to assess changes in satisfaction over time. All of the tests will be two-sided and a p-value of <0.05 will be considered statistically significant.

This pilot study will examine the feasibility of the main RCT study by using the app,identify any recruitment, implementation of the intervention and logistic issues arising from the recruitment, intervention, and follow-ups. It can also provide the preliminary finding for sample size calculation for the main RCT later on.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Tuen Mun Hospital
        • Contact:
          • Shuk Yee Ko
      • Hong Kong, Hong Kong
        • Active, not recruiting
        • Tin Shui Wai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: App support programme group
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
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.
Other Names:
  • Telephone support group
Active Comparator: Telephone support group
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
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.
Other Names:
  • Telephone support group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Self-efficacy and self-management behaviour
Time Frame: Baseline, 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization frequency
Time Frame: 3 months
frequency of hospitalization will be asked.
3 months
Blood pressure
Time Frame: 3 months
systolic and diastolic blood pressure will be collected by trained research assistant.
3 months
Change of cardiovascular endurance test
Time Frame: Baseline, 3 months
Three-minute step test aims to test the client's cardiovascular functional endurance after exercise across the age span and gender. A participant step on and off of a 12-inch high bench/ or stair for 3 minutes. Their pulse is then taken while the participant remains standing. Compare the heart rate with the table according to the age and gender to determine the fitness within a range of 7 scores from excellent to good, above average, average, below average, poor and very poor.
Baseline, 3 months
Change of total physical exercise
Time Frame: Baseline, 3 months
This outcome will be measured using the Godin-Shepherd Leisure Time Physical Activity Questionnaire. This scale measures how often per week and how long per session the respondent has performed strenuous, moderate and mild exercise outside of their work duties.
Baseline, 3 months
Change of perceived stress scale (PSS-10)
Time Frame: Baseline, 3 months
On this scale, 10 self-reported items are used to measure the degree to which situation in a person's life are considered stressful, as well as the current levels of stress experienced in the last month. The summative scores range from 0 to 40, with higher scores indicating higher stress levels. These scores have been used previously to assess the experienced level of stress as an outcome measure and have good psychometric properties in cardiac patients.
Baseline, 3 months
Change of Health literacy
Time Frame: Baseline, 3 months
This outcome will be measured using 24-item Chinese Health Literacy Scale for Chronic Care (CHLCC). This scale has 4 sub scales: remembering, understanding, applying and analyzing. The total scores ranged from 0 to 48, and a higher total score indicates a higher level of health literacy. The CHLCC has good internal reliability ( Cronbach's α=0.91) and good test-retest reliability (intraclass correlation coefficient=0.77; p<0.01).
Baseline, 3 months
Change of Quality of Life:ED-5D
Time Frame: Baseline, 3 months
The ED-5D is a generic instrument used to measure the quality of life in patients with cardiovascular disease in Chinese and other populations. These scale is divided into 5 parts: mobility, self-care, usual activities, pain/discomfort and anxiety/ depression. Participants are asked to respond to the items using the following options: no problem, moderate problems, and extreme problems. The 5 items will also be ranked on a visual analogue scale (VAS) with a range with points from 0 (worst possible health) to 100 (best possible health) to assess the patient's health. The ED-5D was found to be satisfactorily valid and reliable in many populations, including CHD patients.
Baseline, 3 months
Chest pain frequency
Time Frame: 3 months
the frequency of chest pain attack will be record.
3 months
Satisfactory level of the programme
Time Frame: 3 months
the satisfactory level will be asked with the scale 0-10
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body weight
Time Frame: baseline 3 months
body weight will be measured at baseline and 3 months
baseline 3 months
Change in LDL cholesterol
Time Frame: baseline, 3 months
Blood samples for measuring LDL cholesterol will be taken by using a finger stick using auto-analysed and the participants are asked to have 8 hours fasting.
baseline, 3 months
Change in HDL cholesterol
Time Frame: baseline, 3 months
Blood samples for measuring HDL cholesterol will be taken by using a finger stick using auto-analysed and the participants are asked to have 8 hours fasting.
baseline, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

Tuen Mun Hospital

Investigators

  • Principal Investigator: Shuk Yee Ko, Tuen Mun Hospital
  • Principal Investigator: Lip Yip Lee, Tin Shui Wai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

April 30, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

August 5, 2019

First Submitted That Met QC Criteria

August 12, 2019

First Posted (Actual)

August 13, 2019

Study Record Updates

Last Update Posted (Actual)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 12, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16172411

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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