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

November 2, 2016 updated by: Helse Nord-Trøndelag HF

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Namsos, Norway, 7801
        • Medical Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
usual care
Other: Usual care
Experimental: Intervention group
The intervention is an individual nurse-led counselling programme in addition to usual care.
Other: Usual care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from baseline to 6 and 12 months of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from baseline to 6 and 12 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Nord-Trøndelag HF

Investigators

  • Principal Investigator: Liv Heidi Skotnes, phd, Leangen Hospital HNT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

December 22, 2015

First Submitted That Met QC Criteria

December 22, 2015

First Posted (Estimate)

December 28, 2015

Study Record Updates

Last Update Posted (Estimate)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/1568/REK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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