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
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
-
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.