Clinical trial NCT04054258: Program Using a Mobile Application Versus Telephone Advice on Patients at Risk of Coronary Heart Disease : a Pilot RCT
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease
Keywords: coronary heart disease
e-health
self-efficacy
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Tuen Mun Hospital
First posted: 2019-08-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of Self-efficacy and self-management behaviour
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Blood pressure
timeFrame: 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 Health literacy
timeFrame: Baseline, 3 months
measure: Change of Quality of Life:ED-5D
timeFrame: Baseline, 3 months
measure: Chest pain frequency
timeFrame: 3 months
measure: Satisfactory level of the programme
timeFrame: 3 months
measure: Hospitalization frequency
timeFrame: 3 months
Other outcomes:
measure: Change in body weight
timeFrame: baseline 3 months
measure: Change in LDL cholesterol
timeFrame: baseline, 3 months
measure: Change in HDL cholesterol
timeFrame: baseline, 3 months
Locations:
city: Hong Kong
country: Hong Kong
facility: Tin Shui Wai Hospital
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital
Study officials:
affiliation: Tuen Mun Hospital
name: Shuk Yee Ko
role: PRINCIPAL_INVESTIGATOR
affiliation: Tin Shui Wai Hospital
name: Lip Yip Lee
role: PRINCIPAL_INVESTIGATOR
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