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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04054258
• Other study ID #: 16172411
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: July 2021
• Source: The Hong Kong Polytechnic University
• Contact: Mi Ling ML Wong
• Phone: 2766-6544
• Email: eliza.wong[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Tin Shui Wai Hospital	Hong Kong
Hong Kong	Tuen Mun Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Tuen Mun Hospital

Country where clinical trial is conducted

Hong Kong, 

References & Publications (21)

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Siow E, Leung DYP, Wong EML, Lam WH, Lo SM. Do Depressive Symptoms Moderate the Effects of Exercise Self-efficacy on Physical Activity Among Patients With Coronary Heart Disease? J Cardiovasc Nurs. 2018 Jul/Aug;33(4):E26-E34. doi: 10.1097/JCN.0000000000000491. — View Citation

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Wong EM, Chair SY, Leung DY, Sit JW, Leung KP. Home-based interactive e-health educational intervention for middle-aged adults to improve total exercise, adherence rate, exercise efficacy, and outcome: a randomised controlled trial. Hong Kong Med J. 2018 Feb;24 Suppl 2(1):34-38. — View Citation

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in body weight	body weight will be measured at baseline and 3 months	baseline 3 months
Other	Change in LDL cholesterol	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
Other	Change in HDL cholesterol	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
Primary	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	Blood pressure	systolic and diastolic blood pressure will be collected by trained research assistant.	3 months
Secondary	Change of cardiovascular endurance test	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
Secondary	Change of total physical exercise	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
Secondary	Change of perceived stress scale (PSS-10)	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
Secondary	Change of Health literacy	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 a=0.91) and good test-retest reliability (intraclass correlation coefficient=0.77; p<0.01).	Baseline, 3 months
Secondary	Change of Quality of Life:ED-5D	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
Secondary	Chest pain frequency	the frequency of chest pain attack will be record.	3 months
Secondary	Satisfactory level of the programme	the satisfactory level will be asked with the scale 0-10	3 months
Secondary	Hospitalization frequency	frequency of hospitalization will be asked.	3 months

External Links

•   American Heart Association (AHA). 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes.
•   Centers of Disease and Prevention (CDC). The Benefits of Physical Activity. 2018.
•   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
•   World Health Organization (WHO) mHealth, New Horizons for Health through Mobile Technologies, World Health Organization, 2011.
•   World Health Organization. Cardiovascular diseases (CVDs). 2017.