Condition category
Circulatory System
Date applied
10/02/2009
Date assigned
27/03/2009
Last edited
10/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christa Meisinger

ORCID ID

Contact details

Augsburg Hospital
MONICA/KORA Myocardial Infarction Registry
Stenglinstr. 2
Augsburg
86156
Germany
+ 49 821 400 4373
christa.meisinger@helmholtz-muenchen.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BMBF ref: 01ET0713

Study information

Scientific title

A case management intervention for older patients with myocardial infarction: a randomised parallel-group single-centre trial

Acronym

KORINNA

Study hypothesis

The primary objective is to assess whether a case management intervention by trained nurses can reduce readmission in older patients with myocardial infarction.

Ethics approval

Ethics Committee of the Bavarian Chamber of Physicians, approved on 28/07/2008 (ref: 08064)

Study design

Randomised parallel-group single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Coronary heart disease (CHD), myocardial infarction (MI)

Intervention

Experimental intervention: Case management by trained nurse on the basis of telephone contacts and home visits

The study intervention will consist of an initial information session as well as physical examination (approximate duration 2 hours) which will take place one or two days before hospital discharge. In this session, carried out by the study physician together with the study nurse, the specific problems of the patient will be identified and documented. In addition, the patient will be provided with information material about the disease (and comorbidities), about medication and with behavioural recommendations (nutrition, physical activity, smoking etc.).

Furthermore, an individual plan for each patient will be set up. The activities will be planned in agreement with the patient, as this will improve compliance. A first home visit will be arranged (within one to two weeks after discharge or after completion of the rehabilitation), if accepted by the patient, otherwise an appointment for a telephone call will be made. If possible, close relatives of the patient will also be informed in detail and may participate in the discharge session.

The GP of the patient will be informed about the study participation at discharge. The medication at discharge will not be influenced by the intervention. In case of problems with medication, the study nurse will contact the GP of the patient after the first contact with the patient.

Telephone calls (at least every 3 months) and home visits (1 to 4) will be carried out according to patient need. The patients will primarily be responsible themselves to carry out the planned activities, and the study nurse will only support the patients. If the patient needs further assistance or advices, the study nurses will be achievable for the patient in the daytime by telephone on weekdays.

The most important elements of the home visits will be: to detect problems or risks, to give advice and to refer to the general practitioner, if necessary. Risk assessment will be done according to four prespecified risk categories. The higher the group level the more contacts (telephone and home visits) will be arranged by the study nurse. The risk level will be determined by the compliance, the social network, and the comorbidity. The duration of the visit should be between 60 and 90 minutes. At the first home visit patients will be instructed how the prescribed drugs have to be taken and what would happen in the case of non-compliance with medication. Furthermore, to patients with diabetes advice will be given regarding nutrition and physical activity, and to patients with congestive heart failure (CHF) information to encourage regular weight control. During the visits, measurements of blood glucose, blood pressure, and weight will be performed.

Control intervention: Usual care. Patients can use or apply for all available services in the area. In both groups, patients may be subscribed to a disease management program (DMP) if their general practitioner participates in a DMP of their statutory health insurance company. In addition, they may use out-patient nursing services during the follow-up period. However, patients who already receive out-patient nursing services at time of recruitment will be excluded from the study.

Duration of intervention and follow-up per patient: One year

Patients will receive a baseline assessment and will be contacted by phone after 3, 6, and 9 months. Final investigation: after one year

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Time from randomisation to first (unplanned) hospital readmission.

Secondary outcome measures

1. Activities of daily living: Barthel Index and Health Assessment Questionnaire Disability Index (HAQ-DI) (baseline and 1-year follow-up)
2. Instrumental activities of daily living (IADL) scale developed by Lawton/Brody (baseline and 1-year follow-up)
3. Mobility: Timed up and go (baseline and 1-year follow-up)
4. Hand grip strength measurement (baseline and 1-year follow-up)
5. Cognition: Mini Mental State Test (baseline and 1-year follow-up)
6. Nutrition: Seniors in the Community: Risk evaluation for eating and nutrition, Version II (SCREEN II) (baseline and 1-year follow-up)
7. Quality of life: EQ-5D (baseline and 3-/6-/9-/12-months follow-up) and World Health Organization (WHO) Five Well-being Index (baseline and 1-year follow-up)
8. Social network: Social Support Questionnaire (Fragebogen zur Sozialen Unterst├╝tzung [F-SozU]) (baseline and 1-year follow-up)
9. Depression: Geriatric depression Scale (baseline and 1-year follow-up)
10. Items on vision, hearing, chewing and swallowing from Geriatric Assessment (Lachs) (baseline and 1-year follow-up)
11. Baseline questionnaire including items on multimorbidity and physical examination (baseline and 1-year follow-up)
12. Health care utilisation (baseline and 3-/6-/9-/12-months follow-up)

Overall trial start date

01/09/2008

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

All patients of the age group 70 years and older with a first or recurrent myocardial infarction during the recruitment period (September 2008 to December 2009) who are treated in the Augsburg Hospital.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

304

Participant exclusion criteria

1. Patients who already live in institutionalised care or who are already receiving regular support by ambulatory care services. In addition, patients who already plan to move into institutional care or outside the study region within the next months.
2. Patients with severe comorbidity (e.g., terminal cancer) which makes rehospitalisation within the next months necessary or is associated with a life expectancy of less than one year
3. Patients who are not able to communicate in German language
4. Patients who are unable or unwilling to give written informed consent (e.g., patients with dementia)

All consecutive patients screened for eligibility will be documented in a patient log with anonymous data on age, gender, comorbidity, and reasons for ineligibility.

Recruitment start date

01/09/2008

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Germany

Trial participating centre

Augsburg Hospital
Augsburg
86156
Germany

Sponsor information

Organisation

Federal Ministry of Education and Research (BMBF) (Germany)

Sponsor details

Heinemannstr. 2
Bonn
53175
Germany

Sponsor type

Government

Website

http://www.bmbf.de/

Funders

Funder type

Government

Funder name

Federal Ministry of Education and Research (BMBF) (Germany)

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20507567
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24523431
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24168465
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24645907

Publication citations

  1. Protocol

    Kirchberger I, Meisinger C, Seidl H, Wende R, Kuch B, Holle R, Nurse-based case management for aged patients with myocardial infarction: study protocol of a randomized controlled trial., BMC Geriatr, 2010, 10, 29, doi: 10.1186/1471-2318-10-29.

  2. Results

    Hunger M, Kirchberger I, Holle R, Seidl H, Kuch B, Wende R, Meisinger C, Does nurse-based case management for aged myocardial infarction patients improve risk factors, physical functioning and mental health? The KORINNA trial., Eur J Prev Cardiol, 2014, doi: 10.1177/2047487314524682.

  3. Results

    Meisinger C, Stollenwerk B, Kirchberger I, Seidl H, Wende R, Kuch B, Holle R, Effects of a nurse-based case management compared to usual care among aged patients with myocardial infarction: results from the randomized controlled KORINNA study., BMC Geriatr, 2013, 13, 115, doi: 10.1186/1471-2318-13-115.

  4. Results

    Quinones PA, Seidl H, Holle R, Kuch B, Meisinger C, Hunger M, Kirchberger I, New potential determinants of disability in aged persons with myocardial infarction: results from the KORINNA-study., BMC Geriatr, 2014, 14, 34, doi: 10.1186/1471-2318-14-34.

Additional files

Editorial Notes