Combination of specialist treatment and psychosocial intervention in women after a cardiac event

ISRCTN	ISRCTN69468314
DOI	https://doi.org/10.1186/ISRCTN69468314
Protocol serial number	N/A
Sponsor	Public Health Committee/ EXPO-95 (Sweden)
Funder	EXPO-95/ Public Health Committee, Stockholm County Council (Sweden)

Submission date: 07/11/2008
Registration date: 11/12/2008
Last edited: 11/12/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Staffan Ahnve
Scientific

Norrbacka level 6
Department of Public Health Sciences
Karolinska University Hospital
Stockholm
17176
Sweden

Phone	+46 8 737 38 97
Email	Staffan.Ahnve@ki.se

Study information

Primary study design	Interventional
Study design	Open-label randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Combination of specialist treatment and psychosocial intervention in women after a cardiac event: a randomised controlled trial
Study acronym	HFH
Study objectives	Combined intervention of specialist treatment and psychosocial rehabilitation specifically tailored for women's needs improves prognosis and psychosocial functioning.
Ethics approval(s)	Ethics Committee of the Karolinska Institute (Karolinska Institutet), approve on 20/07/1995 (ref: 196/94)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/01/2000

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	250
Key inclusion criteria	1. Women aged <=75 years 2. Those who had either acute myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting
Key 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
Date of first enrolment	21/08/1996
Date of final enrolment	31/01/2000

Locations

Countries of recruitment

Sweden

Study participating centre

Norrbacka level 6

Stockholm
17176
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2008		Yes	No