Individual Nurse-led Counselling Programme for Patients Early Discharged After Myocardial Infarction.
Self-management Behaviour After an Individual Nurse-led Counselling Programme for Patients Early Discharged After Myocardial Infarction: A Randomised Controlled Trial.
1 other identifier
interventional
71
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cardiovascular-diseases
Started Nov 2013
Typical duration for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 22, 2015
CompletedFirst Posted
Study publicly available on registry
December 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedNovember 3, 2016
October 1, 2016
2.7 years
December 22, 2015
November 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
changes in health behaviour
from baseline to 6 and 12 months of follow-up
Study Arms (2)
Intervention group
EXPERIMENTALThe intervention is an individual nurse-led counselling programme in addition to usual care.
Control group
OTHERusual care
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- cognitive impaired/dementia
- planning for coronary artery bypass graft surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Clinic
Namsos, Namsos, 7801, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liv Heidi Skotnes, phd
Leangen Hospital HNT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2015
First Posted
December 28, 2015
Study Start
November 1, 2013
Primary Completion
July 1, 2016
Study Completion
October 1, 2016
Last Updated
November 3, 2016
Record last verified: 2016-10