Individual Nurse-led Counselling Programme for Patients Early Discharged After Myocardial Infarction.
Primary Purpose
Cardiovascular Diseases, Coronary Disease, Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Nurse-led counselling programme
Usual care
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases focused on measuring Practise Patterns, Nurses', Directive Counseling, Self Care
Eligibility Criteria
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
Sites / Locations
- Medical Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention group
Control group
Arm Description
The intervention is an individual nurse-led counselling programme in addition to usual care.
usual care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02640274
First Posted
December 22, 2015
Last Updated
November 2, 2016
Sponsor
Helse Nord-Trøndelag HF
1. Study Identification
Unique Protocol Identification Number
NCT02640274
Brief Title
Individual Nurse-led Counselling Programme for Patients Early Discharged After Myocardial Infarction.
Official Title
Self-management Behaviour After an Individual Nurse-led Counselling Programme for Patients Early Discharged After Myocardial Infarction: A Randomised Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Nord-Trøndelag HF
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Disease, Myocardial Infarction
Keywords
Practise Patterns, Nurses', Directive Counseling, Self Care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention is an individual nurse-led counselling programme in addition to usual care.
Arm Title
Control group
Arm Type
Other
Arm Description
usual care
Intervention Type
Behavioral
Intervention Name(s)
Nurse-led counselling programme
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Primary Outcome Measure Information:
Title
Changes in self-management
Description
Patient activation measure (PAM) consists of 13 items. The questionnaire assesses the patients' knowledge, skill and confidence for managing ones' own health care.
Time Frame
from baseline to 6 and 12 months of follow-up
Secondary Outcome Measure Information:
Title
changes in health behaviour
Description
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.
Time Frame
from baseline to 6 and 12 months of follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liv Heidi Skotnes, phd
Organizational Affiliation
Leangen Hospital HNT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Clinic
City
Namsos
ZIP/Postal Code
7801
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Individual Nurse-led Counselling Programme for Patients Early Discharged After Myocardial Infarction.
We'll reach out to this number within 24 hrs