4.2 Methodology
4.3.6 Data Collection
The researcher implemented the study in the JUH with patients in the early recovery phase. Study data were collected via a self-reporting CSEQ, a socio-demographic data sheet, medical records and an activPAL3™ monitor. To fulfil the study requirements, data collection lasted approximately nine months, excluding the month of Ramadan, a month of fasting, when many changes in people’s lifestyle, eating habits and physical activities occur. The data collection procedure began in March 2015 and ended in December 2015.
The researcher held individual meetings with the head of the cardiology department and the JUH director of nursing units to explain the study objectives, design and methods, including the health professional team role of introducing the study to eligible and willing patients. The researcher then gave informal explanations and an outline of the purpose of the study to the CCU and MCU nurses.
Following research ethics and governance approval, the researcher initially contacted the potential participants and the CCU nurses distributed an invitation letter (Appendix I). The CCU nurses approached all eligible patients with AMI admitted to the CCU about collecting data for the study. The researcher provided verbal and written explanations of the study, as well as the PIS and a consent form, once the patient gave outright approval. The PIS outlined the study’s purpose, methods, ethical approval, the participation’s risks and benefits, information confidentiality, contact details of the researcher and explained that participation in the study was voluntary. The general objective of the PIS was to confirm that each willing participant understood the circumstances of the study before deciding whether or not to participate in it (Bateman, 2002). The researcher provided eligible and willing patients with 12 hours to reflect before deciding whether to participate or not. Then, the
118
researcher asked willing participants to sign a consent form, thus granting their informed and written consent.
Data Collection Procedure
Arrangements for the pre-data collection procedure were as follows. All patients diagnosed with AMI who were willing to participate were included in the study. Nurses working in the CCU approached and identified patients with AMI after admission to the CCU between March and December 2015.
The researcher reassured participants that their participation was entirely voluntary, that all information would be confidential, that all participants’ privacy, respect and dignity would be carefully considered, and that participants could withdraw from the study at any time, without having to give a reason. The researcher also informed them that all participants’ information is confidential and kept for three years after the study for further analysis.
Day 1: Admission to CCU: CCU nurses provided all eligible patients diagnosed with AMI with a PIS 24 hours after admission, if they were stable. After receiving the PIS, the CCU nurse asked patients with an AMI for a decision about participating in the study. When the patients with AMI were haemodynamically stable, such as being free of chest pain, the CCU nurses transferred the patients with AMI to the MCU, where post-PCI patients in a stable health condition can stay. Only if eligible patients with AMI were willing to participate did a CCU nurse contact the researcher.
Days 2 and 3 (after transfer from CCU to MCU), 24 to 48 hours after admission after the patients had received the PIS and were willing to proceed, they met with the researcher in a prescheduled meeting room in the MCU. The researcher scheduled meetings depending on the availability of a meeting room, the patients’ readiness and the researcher’s availability. During the meetings, the researcher introduced himself and briefly explained the study, its objectives and phases, and the participants’ role. At this point, the researcher requested informed consent. Willing participants signed a consent form to enrol in the data collection process at both 2 weeks (Time 1) and 6 weeks (Time 2) after hospital discharge. After patients had signed the informed
119
consent form, the researcher gave the CSEQ and the socio-demographic data sheet to the patient whilst they were in-patients of the MCU. The expected time to complete the study questionnaire was 15 to 30 minutes. Furthermore, the researcher used medical-record data to identify the type of treatment and the diagnosis date of participants. Then, the researcher informed participants that the next data collection times would be 2 weeks and 6 weeks after discharge, in the cardiac outpatient clinic, 30 minutes before their scheduled follow-up appointments
Day 14: (2 weeks after discharge – 1st cardiac outpatient clinic appointment): On the first follow-up appointment day, the researcher met the participants in the cardiac outpatient clinic. An activPAL3™ monitor was attached, BMI was calculated, and the CSEQ and daily diary for chest pain were provided and explained, in addition to an envelope to return the completed questionnaire and an activity monitor and a driver who was assigned to collect the envelopes from the participants’ residence. At this time, the researcher obtained permission from the participants to use their telephone number to facilitate ongoing communication.
After a full 7 days had elapsed, the researcher contacted the participants in order to arrange collection of the activPAL3™ monitors and CSEQs from their homes. In agreement with the University of Salford’s lone working policy code of conduct for off- site visits (HSC/AC issue 12.05.10 version 2), the researcher considered the following points to ensure his safety during the data collection period: firstly, the researcher moved between his home and the JUH by public transport to reduce the possibility of physical harm of the researcher. Secondly, because the Jordanian postal system is not accessible to many citizens, a Jordanian driver with a valid, full driving licence and familiarity with places and addresses in Jordan, was assigned to collect the activPAL3™ monitors and CSEQ. The driver received the activPAL3™ monitors and CSEQ in sealed envelopes that had been given to each of the patients when they received a questionnaire and an activity monitor in the OPD.
120
Day 42 (6 weeks after discharge – 2nd cardiac outpatient clinic appointment): The researcher repeated the same arrangement with the participants after 6 weeks (T2) in order to obtain a second measurement for the CSEQ and the activPAL3™ monitor.
4.3.7 Ethics and Data Management