Improving physical and psychological symptoms in inpatients post heart attack through the symptom self-management programme

• Register: ISRCTN
• Last refreshed on: 24 August 2020
• Main ID: ISRCTN61027816
• Date of registration: 05/08/2014
• Prospective Registration: No
• Primary sponsor: National Medical Research Council (Singapore)
• Public title: Improving physical and psychological symptoms in inpatients post heart attack through the symptom self-management programme
• Scientific title: Improving physical and psychological symptoms in inpatients with acute myocardial infarction through the symptom self-management programme: a pilot randomised controlled trial
• Date of first enrolment: 22/08/2013
• Target sample size: 90
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN61027816
• Study type: Interventional
• Study design: Randomised controlled trial (Quality of life)
• Phase: Not Applicable

Countries of recruitment

Singapore

Contacts

• Name: Piyanee Yobas

Key inclusion & exclusion criteria

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)

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)


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Care for people post-myocardial infarction
Circulatory System

Intervention(s)

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)

Primary Outcome(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).
2. Objective stress will be measured by bio-physiological instruments. Heart rate will be assessed in beats/min. Blood pressure will be measured by using the B-PRO device, a lightweight wristwatch-like blood pressure machine (Dasrao, Yeo, Sim, 2001). Oxygen saturation will be measured by C3G Finger Tip Pulse Oxymeter (Devon Medical, 2011). Skin temperature will be measured by Stress ThermometerTM #SC911 (Biofeedback instrument cooperation, 2003) and lower skin temperature reflects a higher level of stress. Salivary alpha amylase will be analysed using an ELISA method.
3. Subjective stress will be measured with the 7-item Depression subscale of the Depression, Anxiety, and Stress scale (DASS; Lovibond & Lovibond, 1995). The subscale has 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 stress levels. Cronbach?s alphas of the subscale in the range of 0.86 ? 0.90 (Mahmoud et al., 2010).

Secondary Outcome(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. Cronbach?s alphas of the anxiety subscale (0.86-0.90), and depression (0.82 - 0.90) are in acceptable ranges (Mahmoud et al., 2010).
2. Cardiac self-efficacy (participants? confidence in their ability to take care of their health) will be assessed by the 13-item Cardiac Self-efficacy Scale (Sullivan, et al., 1998). Patients will rate on a 5-point scale, from 0 (not at all confident) to 4 (completely confident). Total scores range from 0 to 52 with higher scores indicating greater levels of cardiac self-efficacy. The scale has high internal consistency (? = 0.87) with good discriminant/convergent validity (Sullivan, et al., 1998).
3. Perceived relaxation will be measured by the perceived relaxation scale. Participants will rate their relaxation level on a single-item Numeric Rating Scale: a 10-centimetre continuum line starting from 0 (very tensed) to 10 (very relaxed).
4. The number of rehospitalisation and emergency visits within six months following the current hospitalisation will be retrieved from patients? records.
5. Length of hospital stay associating with the current episode of AMI will be recorded in number of days.
6. Healthcare cost will be retrieved from patients? records. All medical expenses relating to the treatments of AMI within six months will be collected. Patients will also be asked about healthcare expenses relating to AMI treatments they receive at other healthcare facilities during the first follow-up visit (one month) and six months later.
7. Perception of interventions will be obtained through open-ended questions. Participants will describe how they feel about the programmes, identify strengths/weaknesses, list most helpful/least helpful aspects, indicate undesirable effects (if any), and provide suggestion for improvement.
8. Demographic information (including age, gender, education, religion, housing arrangement, occupation, family income) and clinical data (medical diagnoses, length of medical diagnoses, and treatments) will be collected.

Secondary ID(s)

HSRNIG12nov005

Source(s) of Monetary Support

National University of Singapore (NUS) (Singapore) - Health Service Research, New Investigator Grant

Ethics review

Status:
Approval date:
Contact:

NHG Domain Specific Review Board (DSRB); 31/10/2013; ref. 2013/00801

Results

• Results available: Yes
• Date Completed: 31/08/2015