Combination of specialist treatment and psychosocial intervention in women after a cardiac event
| ISRCTN | ISRCTN69468314 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69468314 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Norrbacka level 6
Department of Public Health Sciences
Karolinska University Hospital
Stockholm
17176
Sweden
| Phone | +46 8 737 38 97 |
|---|---|
| Staffan.Ahnve@ki.se |
Study information
| Study design | Open-label randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| 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 | 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 study start date | 21/08/1996 |
| Completion date | 31/01/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
17176
Sweden
Sponsor information
Public Health Committee/ EXPO-95 (Sweden)
Government
Government
Norrbacka level 8
Karolinska University Hospital
Stockholm
17177
Sweden
| Website | http://www.karolinska.se |
|---|---|
"ROR" |
https://ror.org/00m8d6786 |
Funders
Funder type
Government
EXPO-95/ Public Health Committee, Stockholm County Council (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
