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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02640274
• Other study ID #: 2013/1568/REK
• Status: Completed
• Phase: N/A
• First received: December 22, 2015
• Last updated: November 2, 2016
• Start date: November 2013
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Central Norway Regional Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction

Intervention

Behavioral:
• Nurse-led counselling programme
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.

Other:
• Usual care

Locations

Country	Name	City	State
Norway	Medical Clinic	Namsos

Sponsors (1)

Lead Sponsor	Collaborator
Central Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No