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.
- 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.
- 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.
