Condition category
Circulatory System
Date applied
07/11/2008
Date assigned
11/12/2008
Last edited
11/12/2008
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

Prof Staffan Ahnve

ORCID ID

Contact details

Norrbacka level 6
Department of Public Health Sciences
Karolinska University Hospital
Stockholm
17176
Sweden
+46 8 737 38 97
Staffan.Ahnve@ki.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Combination of specialist treatment and psychosocial intervention in women after a cardiac event: a randomised controlled trial

Acronym

HFH

Study hypothesis

Combined intervention of specialist treatment and psychosocial rehabilitation specifically tailored for women's needs improves prognosis and psychosocial functioning.

Ethics approval

Ethics Committee of the Karolinska Institute (Karolinska Institutet), approve on 20/07/1995 (ref: 196/94)

Study design

Open-label randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting

Intervention

The participants were randomly assigned (randomisation ratio 1:1) to the following two groups:

Intervention group: A combination of the following two interventions:
1. Specialist treatment (cardiologist) as opposed to usual care
2. A 1-year intervention consisting of a psychosocial rehabilitation based on cognitive-behavioural therapy principles tailored to women's needs (20 x 2-hour sessions)

Control group: Usual care only.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Patients were followed-up for the following primary outcomes for 6.5 years on average through Swedish health care registers:
1. Mortality
2. Non-fatal myocardial infarction

Secondary outcome measures

Psychosocial functioning, assessed by the following questionnaires:
1. Beck Depression Inventory
2. Mastricht Questionnaire measuring vital exhaustion
3. Daily Stress Behaviour Questionnaire
4. Availability of Social Integration
5. Availability of Attachment

All secondary outcomes were assessed at the following four timepoints:
T1: At baseline (6-8 weeks after randomisation)
T2: After 10 weeks i.e. after 10 intervention sessions
T3: After 1 year (end of intervention)
T4: At 1-2 year follow-up measurement

Overall trial start date

21/08/1996

Overall trial end date

31/01/2000

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women aged <=75 years
2. Those who had either acute myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

250

Participant exclusion criteria

1. Women >75 years of age
2. Those not communicating in the Swedish language
3. Those who participated in other research studies
4. Those who did not belong to the hospital catchment area
5. Those who had serious co-morbidity that would preclude taking part in the 1-year intervention programme, such as malignancy or psychiatric disease

Recruitment start date

21/08/1996

Recruitment end date

31/01/2000

Locations

Countries of recruitment

Sweden

Trial participating centre

Norrbacka level 6
Stockholm
17176
Sweden

Sponsor information

Organisation

Public Health Committee/ EXPO-95 (Sweden)

Sponsor details

Norrbacka level 8
Karolinska University Hospital
Stockholm
17177
Sweden

Sponsor type

Government

Website

http://www.karolinska.se

Funders

Funder type

Government

Funder name

EXPO-95/ Public Health Committee, Stockholm County Council (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18067552

Publication citations

  1. Results

    Koertge J, Janszky I, Sundin O, Blom M, Georgiades A, László KD, Alinaghizadeh H, Ahnve S, Effects of a stress management program on vital exhaustion and depression in women with coronary heart disease: a randomized controlled intervention study., J. Intern. Med., 2008, 263, 3, 281-293, doi: 10.1111/j.1365-2796.2007.01887.x.

Additional files

Editorial Notes