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

Improving physical and psychological symptoms in inpatients with acute myocardial infarction through the symptom self-management programme: a pilot randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN61027816

Enrollment

Registered

2014-08-05

Start date

2013-08-22

Completion date

Unknown

Last updated

2020-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Care for people post-myocardial infarction Circulatory System

Interventions

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 day

Eligibility

Sex/Gender

All

Inclusion 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

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)

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
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 wi	—

Measure

Time frame

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 wi

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Countries

Singapore

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026