OPTICARE-M/F: Towards a sex and gender sensitive approach of cardiac rehabilitation
Projectomschrijving
Hartrevalidatie is gericht op het ontwikkelen van een actieve leefstijl en op het verbeteren van gezondheid. Er is weinig bekend over het effect van hartrevalidatie bij vrouwen.
Doel
In dit onderzoek bekijken we of mannen en vrouwen gelijkwaardig profiteren van hartrevalidatie en of vrouwen baat hebben bij aanvullende programma’s voor het bevorderen van een actieve leefstijl (een programma in groepsverband of een telefonisch programma).
Resultaten hartrevalidatie bij vrouwen
De resultaten van de OPTICARE-M/F studie laten zien dat vrouwen hartrevalidatie starten met een minder actieve leefstijl, een lagere fysieke fitheid en een lagere mentale gezondheid en kwaliteit van leven dan mannen. Dit wordt ook gezien in de algehele populatie. Niettemin profiteren vrouwen en mannen gelijkwaardig van hartrevalidatie op het gebied van fysieke activiteit, fysieke fitheid, cardiovasculair risicofactorbeheer en kwaliteit van leven. Verbetering van de mentale gezondheid is zelfs iets groter bij vrouwen. Deze resultaten onderstrepen het belang van deelname aan hartrevalidatie voor vrouwen en suggereren dat speciale hartrevalidatie programma’s voor vrouwen niet nodig zijn.
Resultaten op gebied van diversiteit
Aanvullend hebben we gekeken of leeftijd, sociaaleconomische status, etniciteit, en opleidingsniveau van invloed zijn op de effecten van hartrevalidatie. Deelnemers met een hogere leeftijd bereikten minder verbeteringen op het gebied van participatie in de samenleving, mentale gezondheid, vermoeidheid en kwaliteit van leven. Sociaaleconomische status, etniciteit en opleidingsniveau lijken weinig invloed te hebben op de effectiviteit van hartrevalidatie.
Verslagen
Eindverslag
Samenvatting van de aanvraag
BACKGROUND Cardiac rehabilitation (CR) guidelines are mainly based on research performed in men. Previous studies suggest a gender gap: women seem to be in greater need of CR, but are less likely to adhere and benefit. More in-depth research on sex and gender differences in CR outcomes is warranted. OBJECTIVE The primary purpose is to perform additional analyses on the data collected in the randomized controlled OPTICARE trial to explore the role of sex and gender differences in the efficacy of different types of CR on objectively measured physical activity and health. Secondary, the role of age, educational level, ethnicity and socio-economic status in the efficacy of CR will be explored. HYPOTHESIS Previous studies suggest that women enter CR with lower physical activity levels and might benefit less from standard CR. Women seem to need more guidance with lifestyle changes and have other CR needs. Therefore, we hypothesize that women, as compared to men, will profit less from standard CR and relatively more from additional behavioral CR sessions. OPTICARE STUDY AND DATABASE The OPTICARE study is a randomized controlled trial. In total, 914 patients with cardiovascular disease (CVD) participating in CR were enrolled between November 2011 and August 2014, of whom 175 women (19%). OPTICARE provides an unique series of patients: data is collected in a large, representative group of patients with CVD; three different types of behavioral CR interventions were investigated; patients were followed-up for 1.5 years; and physical activity was measured objectively with accelerometers. OPTICARE provides one of the largest randomized controlled trials with objective physical activity outcomes in women with CVD. Patients were randomized to: 1) 3 months of standard CR (CR-only), which combines aerobic fitness training with educational sessions and modules (diet/stress management/smoking cessation); 2) 3 months of standard CR with three face-to-face PA behavioral group counseling sessions followed by 9 months of aftercare with three general lifestyle, face-to-face group counseling sessions (CR+F); 3) 3 months of standard CR, followed by 9 months of aftercare with five to six general lifestyle, telephonic behavioral counseling sessions (CR+T). SEX, GENDER AND DIVERSITY IN OPTICARE DATABASE Biological sex was conceptualized as a binary outcome (woman and man) in the database. A measure of gender is currently not available in the database, but will be determined in the proposed study by calculating a gender-index based on gender roles. Information on age and educational level is available in the database. Information on ethnicity and socio-economic status is currently not available and will be determined as part of the proposed study. OUTCOME MEASURES An objective accelerometer recorded the primary outcome physical activity during 7 days. Secondary outcomes are sedentary behavior, fatigue, participation in society, quality of life, anxiety and depression, cardio metabolic risk, and aerobic capacity. All outcomes were measured at randomization, 3 months, 12 months, and 18 months. ANALYSIS Sex and gender differences in outcomes of standard CR and CR extended with additional interventions (CR+F and CR+T) will be analyzed by stratification. In case sex- or gender differences in intervention effects are found, second level sub-group disaggregation will be performed to unmask whether these differences can be attributed to the factors age, educational level, ethnicity and/or socio-economic status. Furthermore, in case sex and/or gender differences in intervention effects are confirmed, a total of 20 female patients with CVD and 5 health care providers will be contacted for a semi-structured interview to gain additional knowledge on perceived facilitators and barriers for CR participation. In addition, we will perform analyses to determine whether age, socio-economic status, ethnicity and educational status are independent predictors for the efficacy of standard CR and CR extended with additional interventions (CR+F and CR+T). ADDED VALUE The proposed analyses are based on relevant questions by health professionals and patients after publication of our main findings. The outcomes of the additional analyses might improve the quality of CR regarding physical activity, and consequently health, for women in several directions: by improving awareness among health professionals of sex and/or gender differences in CR outcomes; by initiating more targeted new research projects to optimize CR for women; and as a first step towards adapting the CR guidelines for women. In addition, quality of CR might be optimized for other subgroups based on age, educational level, ethnicity and socio-economic status. TIME SCHEDULE Dec 2018-Feb 2019: Data synthesis Feb -May 2019: Analyzing data May-Sept 2019: Writing papers; performing semi-structured interviews Aug -Nov 2019: Publishing and presenting outcomes; writing report with recommendations.