NCT02640274

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 3, 2016

Status Verified

October 1, 2016

Enrollment Period

2.7 years

First QC Date

December 22, 2015

Last Update Submit

November 2, 2016

Conditions

Keywords

Practise Patterns, Nurses'Directive CounselingSelf Care

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

EXPERIMENTAL

The intervention is an individual nurse-led counselling programme in addition to usual care.

Behavioral: Nurse-led counselling programmeOther: Usual care

Control group

OTHER

usual care

Other: Usual 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.

Intervention group
Control groupIntervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseMyocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Liv Heidi Skotnes, phd

    Leangen Hospital HNT

    PRINCIPAL INVESTIGATOR

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

Locations