To describe physical activity level before and after CRT implantation and to explore factors related to the intention of patients with HF for implementing behaviour change (improve activity level). We want to collect this data to plan future…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Daily physical activity
• Self-reported activity level
Secondary outcome
• Submaximal Exercise Capacity
• Exercise Motivation
• Health related Quality of life and well-being.
• Anxiety and depression
• LV volumes and function measured by echocardiography
• NT-proBNP levels
• Number of missing questionnaires at T0, T1, T2 and T3
Background summary
Physical activity, including regular exercise, is important for patients with
heart failure (HF). One might expect that after a CRT implantation, patients
are in a better shape to more active and will be able to change their physical
activity. However, it is known that more is needed to change behaviour, for
example to being motivated and feeling empowered to be more active. An
intervention at home using eHealth seems promising to improve physical
activity. However, to design an eHealth intervention for this patient group,
more information is needed on their actual activity level, their motivation and
barriers for physical activity and the perceived role of patients themselves.
Study objective
To describe physical activity level before and after CRT implantation and to
explore factors related to the intention of patients with HF for implementing
behaviour change (improve activity level). We want to collect this data to plan
future research. We also collect data on the feasibility of such a study. The
long term goal is to develop an eHealth intervention.
Study design
This study is a descriptive longitudinal pilot study with 12 months follow-up.
Study procedures
Baseline visit: about 2 months before CRT implantation
- Demographic and clinical data are collected from the electronic health record;
- Respondent complete digital questionnaires at home;
- Combined with the regular outpatient visit, a research nurse administers the
6-minute walk test and the respondent is instructed on the activity meter and
receives it to wear for 2 weeks (excluding at night).
Follow up visits: About 2 and 6 months after CRT implantation
- Demographic and clinical data are collected from the electronic health record
- Respondents complete digital questionnaires at home
- Combined with the regular outpatient visit, a research nurse administers the
6-minute walk test and the respondent is instructed on the activity meter and
receives it to wear for 2 weeks (excluding at night).
Follow up visit: about 12 months
- Demographic and clinical data are collected from the electronic health record
- Respondents complete digital questionnaires at home
Study burden and risks
No medical intervention is performed in the context of this study. The burden
consists of completing questionnaires 4 times (30 minutes each time), doing a
6-minute walk test 3 times and wearing an activity monitor 3 times for 2 weeks
in 12 months. Since we collect data during scheduled visits, no additional
outpatient clinic visits are required and we believe our study is safe.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Diagnosis of chronic heart failure according to the prevailing guidelines
- Elective first-time implantation of CRT (pacemaker (CRT-P) or defibrillator
(CRT-D)) in UMCU
- Adult (age >= 18 years)
Exclusion criteria
- Scheduled cardiac surgery within 3 months
- Problems to fill in questionnaires
- Problems to wear an activity monitor
- Previously implanted pacemaker or defibrillator device
- On an active waiting list for left ventricular assist device (LVAD)
implantation or heart transplantation
- Inability to provide informed consent
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 |
---|---|
CCMO | NL80692.041.23 |