Individual Nurse-led Counselling Programme for Patients Early Discharged After Myocardial Infarction.

Study Overview
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Brief Summary
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The European guidelines of cardiovascular disease prevention recommend treatment modalities, such as lifestyle changes in order to minimize the risk of further cardiac event after a myocardial infarction (MI). However, a considerable gap exists between guidelines and their implementation in clinical practise. Further, less is known about the impact of different interventions on patient's knowledge, skills and confidence necessary for self-management after MI. Aim: To evaluate and compare the short- and long-term effects of an individual nurse-led counselling programme together with usual care for patients early discharged after MI on self-management behaviour.

Official Title
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Self-management Behaviour After an Individual Nurse-led Counselling Programme for Patients Early Discharged After Myocardial Infarction: A Randomised Controlled Trial.

Conditions
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Cardiovascular Diseases, Coronary Disease, Myocardial Infarction

Intervention / Treatment
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* Behavioral: Nurse-led counselling programme
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Patients with documented evidence of myocardial infarction during hospitalisation will be considered for inclusion. patients over 18 years old living at home in the local hospital area after hospital discharge able to receive telephone calls, fill in questionnaire and communicate in Norwegian. Exclusion Criteria: cognitive impaired/dementia planning for coronary artery bypass graft surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The intervention is an individual nurse-led counselling programme in addition to usual care. | Behavioral: Nurse-led counselling programme<br>* The intervention is an individual nurse-led counselling programme in addition to usual care. The intervention includes 3 outpatient clinic visits (at weeks 2, 14 and 26) and two telephone calls (at weeks 4 and 16) by a cardiovascular nurse during the first 6 months early discharged. The counselling focuses on cardiac risk reduction behaviour based on guidelines issued by European Society of Cardiology and self-management support.<br>Other: Usual care<br> <br> |
| Other: Control group<br>usual care | Other: Usual care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in self-management | Patient activation measure (PAM) consists of 13 items. The questionnaire assesses the patients' knowledge, skill and confidence for managing ones' own health care. | from baseline to 6 and 12 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in health behaviour | The SmartDiet questionnaire consists of 21 questions registering average use of certain group of food and lifestyle. The questions about physical activity is a questionnaire about frequency, duration and intensity of physical activities. | from baseline to 6 and 12 months of follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Practise Patterns, Nurses', Directive Counseling, Self Care