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Completed

NCT Number: NCT02640274

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Clinic

Namsos, 7801, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nurse-led counselling programme

Behavioral

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.

Usual Care

Other

Primary outcomes

  1. Changes in self-management

    Time frame: from baseline to 6 and 12 months of follow-up

    Patient activation measure (PAM) consists of 13 items. The questionnaire assesses the patients' knowledge, skill and confidence for managing ones' own health care.

Secondary outcomes

  1. changes in health behaviour

    Time frame: from baseline to 6 and 12 months of follow-up

    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.

Sponsors and collaborators

Lead sponsor

Helse Nord-Trøndelag HF

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 28, 2015
Registry last updated
Nov 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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