To assess the feasibility of a tailored eHealth intervention (primary) for cardiac patients with a low socio-economic position and explore its effect on patient activation, certainty and guidance (secondary) compared to usual care.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility of the intervention in terms of usage, acceptability and
experience.
- Usage will be determined based on the number of days used, length of use
(period from first to last day use), number of viewed messages and time spent
per visit.
- Acceptability will be measured using a self-designed questionnaire (9 items)
based on the USE questionnaire (Usability, Usefulness and satisfaction)
- Experience will be determined based on a thematic analysis of several
qualitative semi-structured interviews.
Secondary outcome
- Patient activation measured using the PAM-13 questionnaire. We use the Dutch
translation of this questionnaire consisting of 13 items with a 4-point Likert
scale.
- Feelings of certainty and guidance using a self-designed questionnaire (9
items).
Background summary
Health disparities between socioeconomic classes are growing. Certain
neighbourhoods with a lower socio-economic position (SEP) display generally a
higher prevalence of unhealthy lifestyles. A possible cause is lower levels of
patient activation (being able to manage your health). Improving patient
activation for some groups therefore seems important to facilitate their
success within their cardiac rehabilitation. In a preliminary study we found
that patients indeed have a passive attitude towards their condition,
especially during the so-called *waiting period* (the period between discharge
from the hospital and start of the rehabilitation). Activating patients in this
period could be beneficial for the success of their upcoming rehabilitation as
well as their long-term health. Therefore, we have developed a tailored eHealth
intervention aimed at improving patient activation levels by supporting
patients with a low SEP during their waiting period.
Study objective
To assess the feasibility of a tailored eHealth intervention (primary) for
cardiac patients with a low socio-economic position and explore its effect on
patient activation, certainty and guidance (secondary) compared to usual care.
Study design
Randomised pilot study
Intervention
Patients will be enrolled in the intervention group based on randomization. The
intervention group will use an eHealth application during the waiting period
before cardiac rehabilitation starts. The app asks patients to engage with
preparatory messages daily. Messages are pre-made and consist of videos about
the rehabilitation, written tips and spoken success stories. The control group
will go through the usual waiting period before the start of cardiac
rehabilitation.
Study burden and risks
Both intervention and control group will receive CR as usual, as recommended by
guidelines. Before CR starts, participants in the intervention group are asked
to use an eHealth application daily. The app shows daily messages provided by
representatives of different disciplines within CR. Use of the app per day
depends on the length of messages but can range between 5 and 10 minutes per
day. The content of the app is developed in collaboration with healthcare
workers at the rehabilitation center. Patients in the control group do not have
this eHealth application in their waiting period.
Both groups will be asked to fill in a questionnaire at two moments during
their rehabilitation:
T1: Face-to-face group meeting within one week after signing enrollment in CR
(rehabilitation agreement) about demographics, certainty, guidance and
activation consisting of 25 questions and taking approximately 8 minutes.
T2: At the start of the rehabilitation (usually after 2 to 6 weeks from T1)
about:
Control: Certainty, guidance, and activation consisting of 22 questions taking
approximately 7 minutes.
Intervention: Acceptability, certainty, guidance, and activation, consisting of
31 questions and taking approximately 10 minutes
To minimize the burden for participants, at the start of the study,
participants can indicate their preferred medium for filling in the
questionnaires (email or postal mail) for T2. Additional semi-structured
interviews (regarding experience, 30 minutes) will be held at T2 with a subset
(estimated: N * 10) of the participants in the intervention group. Participants
are free to choose where they want to do the interviews, either at the CR
center, or at their home. Finally, to minimize the burden of the participants
using the intervention, we will clarify that reading the messages is not
obligatory and that they can be read at any time during the day.
We take additional precautions regarding the SEP of our participants:
we will be clear about the nature of the research while avoiding
stigmatization. We will do this by avoiding words that imply marginalization in
our communications (e.g. IC form). We will ensure our communications, written
as well as verbal, are clear and understandable.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
Patients with a low socio-economic position who are eligible for participation
in cardiac rehabilitation and who are referred by their cardiologist to Capri
Hartrevalidatie.
Exclusion criteria
Patients with severe physical, psychological, or cognitive impairments.
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 | NL81969.078.22 |