Improving physical and psychological symptoms in inpatients post heart attack through the symptom self-management programme
| ISRCTN | ISRCTN61027816 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61027816 |
| Protocol serial number | HSRNIG12nov005 |
| Sponsor | National Medical Research Council (Singapore) |
| Funder | National University of Singapore (NUS) (Singapore) - Health Service Research, New Investigator Grant |
- Submission date
- 18/06/2014
- Registration date
- 05/08/2014
- Last edited
- 12/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Heart attack [acute myocardial infarction (AMI)] is the leading cause of death across the world. Generally, people with AMI have severe physical symptoms (such as chest pain, breathlessness, and vomiting) requiring immediate treatment and hospitalization. They are also at a risk for developing psychological symptoms such as stress, depression, and anxiety. Therefore, there is a need to develop nursing interventions to help people manage their physical and psychological symptoms after a heart attack. This study aims to find out if the symptom self-management program can help patients self-manage their physical and psychological symptoms after a heart attack.
Who can participate?
Adult patients admitted in the hospital, who have a confirmed diagnosis of acute myocardial infarction.
What does the study involve?
Enrolled participants will be randomly allocated to one of these treatment conditions: a) hospital standard care (control group), b) standard care with the symptom self-management program delivered through virtual reality device (IManage-VR) which has audio-visual presentations, and c) standard care with the symptom self-management program delivered through a face-to-face method (IManage-FF).
What are the possible benefits and risks of participating?
Those in the IManage-VR and IManage FF groups will have the opportunity to learn how to manage physical and psychological symptoms relating to heart attack. Risks are not expected from participating in this study. Participants in the control group will receive standard care provided by hospital.
Where is the study run from?
Cardiovascular wards at a tertiary hospital in Singapore
When is the study starting and how long is it expected to run for?
The study started in August 2013 and will run for two years
Who is funding the study?
National University of Singapore (NUS) (Singapore)
Who is the main contact?
Dr Piyanee Yobas
nurpk@nus.edu.sg
Contact information
Scientific
Alice Lee Centre for Nursing Studies
National University of Singapore
Level 2, Medical Research Centre, MD11
10 Medical Drive
Singapore
117597
Singapore
| Phone | +65 (0)65167789 |
|---|---|
| nurpk@nus.edu.sg |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Improving physical and psychological symptoms in inpatients with acute myocardial infarction through the symptom self-management programme: a pilot randomised controlled trial |
| Study objectives | Hypothesis 1: In comparison with the control group, inpatients post-acute myocardial infarction (post-AMI) who complete the symptom self-management programme will report significantly: 1.1. Lower levels of chest pain, stress, anxiety, depression, number of re-hospitalization and emergency visits, and health care cost 1.2. Greater levels of perceived relaxation and cardiac self-efficacy Hypothesis 2: Participants in the experiment and control groups will identify strengths, weaknesses, usefulness, areas for improvement, and undesirable effects of the programme they attend. |
| Ethics approval(s) | NHG Domain Specific Review Board (DSRB); 31/10/2013; ref. 2013/00801 |
| Health condition(s) or problem(s) studied | Care for people post-myocardial infarction |
| Intervention | There are three treatment conditions in this study 1. The IManage-VR programme is a two one-hour individual-based symptom self-management intervention delivered in two consecutive days, four weekly follow-up telephone calls, a booster session, and homework assignment. This programme, delivered via a virtual reality (VR) device, comprises an educational component, the practice of relaxation techniques, and a homework assignment. The VR device is perceived to induce quicker and deeper relaxation as it simultaneously offers pleasant visual presentations (e.g., peaceful sceneries) and audio functions (e.g., music and voice instruction). Furthermore, the use of the VR device is perceived to better reduce distractions from the environment and thus may enhance learning outcomes. 2. The IManage-FF programme is a two one-hour individual-based symptom self-management intervention delivered in two consecutive days, four weekly follow-up telephone calls, a booster session, and homework assignment. It will also contain two major components: education and the practice of relaxation techniques. However, this programme will be delivered using a conventional face-to-face method. Only audiotape instruction (i.e. relaxation CD) will be used to guide the practice of relaxation. 3. Standard care includes usual evidence-based treatments and services provided by the hospital. All patients also receive a single-session, individual-based, one-hour long patient education. This session teaches patients about AMI and management of AMI (such as healthy diet and exercise) |
| Intervention type | Other |
| Primary outcome measure(s) |
1.Chest pain will be measured by the perceived chest pain scale. On the single-item Numeric Rating Scale (a 10-centrimetre continuum line), participants will give a number corresponding to their pain level between 0 (no pain) and 10 (unbearable pain). |
| Key secondary outcome measure(s) |
1. Anxiety and depression will be measured with corresponding subscales of the DASS (Lovibond & Lovibond, 1995). Each subscale has seven items with four response categories ranging from 0 (did not apply to me at all) to 3 (applied to me most of the time). Possible scores of each subscale are in the range of 0 - 21 with higher scores indicating higher anxiety or depression levels. Cronbachs alphas of the anxiety subscale (0.86-0.90), and depression (0.82 - 0.90) are in acceptable ranges (Mahmoud et al., 2010). |
| Completion date | 31/08/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 90 |
| Key inclusion criteria | 1. Adult inpatients of any gender aged between 21 to 65 years old 2. Having a confirmed diagnosis of AMI by their attending physician 3. Having an ability to communicate in English 4. Having access to a computer, tablet, or smartphone at home (to review VCD/CD) |
| Key exclusion criteria | 1. Are less than 21 or older than 65 years old 2. Present with severe comorbidity (such as congestive heart failure) 3. Have been diagnosed with mental disorders (such as schizophrenia) |
| Date of first enrolment | 22/08/2013 |
| Date of final enrolment | 31/08/2015 |
Locations
Countries of recruitment
- Singapore
Study participating centre
117597
Singapore
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/06/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/08/2020: No results publications found.
29/02/2016: Publication reference added.