To develop an effective lifestyle intervention for cardiac patients based on self-regulation theory aimed at health behavior change and maintenance.
ID
Source
Brief title
Condition
- Myocardial disorders
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Short-term targets (6 months after start of cardiac rehabilitation) of the
study are:
a) (maintenance of) risk behavior change (i.e., smoking, exercising, eating
behavior)
b) improved self-regulation skills
c) improved quality of life
Long-term targets (two years after start of cardiac rehabilitation) include:
d) improvement in cardiovascular risk factors (cholesterol, blood pressure,
weight)
(e) reduced health care utilization
(f) better return to work
Secondary outcome
Please see above
Background summary
Coronary heart disease (CHD) is the leading fatal illness in the Netherlands,
accounting for 33% of all deaths in 2003 (Koek, van Dis, Peters & Bots, 2005).
Extensive clinical and epidemiological studies have identified several risk
factors for CHD. The most important factors include smoking, diabetes mellitus,
high blood pressure, high cholesterol, heredity, and obesity. Cardiac
rehabilitation programs focusing on behavior modification and stress management
have been shown to successfully reduce the incidence of new cardiac events and
cardiac mortality and to have positive effects on blood pressure, cholesterol,
body weight, smoking behavior, physical exercise, and eating habits
(Dusseldorp, Van Elderen, Maes, Meulman & Kraaij, 1999). However, these effects
on behavior change were primarily measured on a short-term basis. Research on
the maintenance of health-behavior change indicates that sustaining recommended
health behaviors over time is still problematic. A European survey on
lifestyle and risk factor management in coronary patients six months to one and
a half years after discharge from hospital, showed that in the Netherlands, 28%
of the patients smoked cigarettes, 79% were overweight, 28% were obese, 54% had
raised blood pressure, and 44% had elevated serum total cholesterol (Euroaspire
II Study Group, 2001). Thus, there seems considerable room for improvement.
Study objective
To develop an effective lifestyle intervention for cardiac patients based on
self-regulation theory aimed at health behavior change and maintenance.
Study design
Randomised controlled study.
Upon completion of the cardiac rehabilitation program, patients in the
experimental condition will participate in the self-regulation lifestyle
intervention. Patients in the control condition will receive standard cardiac
care.
Intervention
The intervention will start with a motivational interview in which the
patient*s motivation and self-efficacy for health behavior change and/ or
maintenance will be discussed, and the patient is encouraged to select a
salient health goal that he or she feels motivated to achieve. Following the
interview, patients will participate in seven group sessions focusing on
acquiring self-regulation skills associated with successful goal pursuit. The
group sessions will be based on the guidelines for self-regulation
interventions (Maes & Karoly, 2005) and will incorporate the *Look, Choose,
Act, and Check* structure. Patients will be encouraged to first *Look* at their
behavior and monitor the frequency and context in which the behavior tends to
occur. This may include keeping a food diary or wearing a pedometer. This
information will form the basis for the *Choose* stage, in which patients
formulate small steps towards goal achievement and select ways of rewarding
themselves when progress is made. Techniques for effective self-monitoring,
anticipatory coping methods, and evaluation of progress will be discussed in
the *Act* stage. Special attention will be paid to conflicting or competing
goals and situations that may trigger nonadherence. Patients will also be
encouraged to engage in positive self-talk. In the final stage, patients will
be taught how to *Check* and evaluate their progress towards their goal.
Patients will also focus on how to receive social support from the environment
(i.e., partner, family, friends) and how to profit from this. All of the
group-sessions will be paralleled by homework assignments, offered in the
Self-Regulation Manual.
Study burden and risks
All patients will be asked to fill out a set of questionnaires (35 min) at four
different moments over a period of two years. In addition, patients will be
interviewed about their lifestyle in a short telephone interview (20 min).
Secondly, trained psychologists will visit patients at home to measure weight
and bloodpressure. Finally, patients are required to have their cholesterol
measured at SCAL Diagnostisch Centrum.
Patients in the experimental group will also participate in a motivational
interview (1hr), and will be asked to attend seven group sessions at the
rehabilitation centre.
Postbus 9555
2300 RB Leiden
NL
Postbus 9555
2300 RB Leiden
NL
Listed location countries
Age
Inclusion criteria
Presence of one or more of the following risk factors: hypertension, dislipidaemia, smoking, being overweight, and physical inactivity. (For definitions of these risk factors see research protocol, page 8). Fluency in the Dutch language, a minimum age of 18 and a maximum age of 75.
Exclusion criteria
Absence of any of the aforementioned risk factors. Being currently under psychiatric treatment.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
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CCMO | NL15017.058.07 |