Cardiac DiseasePReCARENCT05698121
Evaluation of a Preparatory eHealth Intervention to Support Cardiac Patients During Their Waiting Period.
A study testing CapriXpress in people with Cardiac Disease, run by Erasmus Medical Center at 2 sites in Netherlands.
Trial summary
The goal of this pilot study is to evaluate the feasibility of an eHealth intervention for cardiac patients during their waiting period before their rehabilitation. The main questions it aims to answer are: What is the feasibility of an eHealth intervention designed for cardiac patients with a low socio-economic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- CapriXpress
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesNetherlands
- Study dates
- 8 Feb 2023to 23 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is eligible for participation in cardiac rehabilitation
- The patient has signed the standard rehabilitation agreement provided by the rehabilitation centre and has agreed to be contacted for research purposes
- The patient is aged 18 years or above
- The patient signs an informed consent form
- The patient is sufficient in the Dutch language
- The patient has access to a mobile phone with internet
- The patient is identified as someone with a low SEP, which will be determined by the socioeconomic status of the neighbourhood
Who cannot join
- Upon referral, the medical status of the patient is screened by a physician of the CR center. Patients with severe physical, psychological, or cognitive impairments will not be included in the study.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Capri Hartrevalidatie
Rotterdam, South Holland, 3062 MA
Capri Hartrevalidatie
The Hague, South Holland
About this study
Official title: PReCARE - Evaluation of a Preparatory eHealth Intervention for Patients With a Low SEP in Cardiac Rehabilitation: a Pilot Study.
The goal of this pilot study is to evaluate the feasibility of an eHealth intervention for cardiac patients during their waiting period before their rehabilitation.
The main questions it aims to answer are:
Read more
- What is the feasibility of an eHealth intervention designed for cardiac patients with a low socio-economic position during the waiting period before their cardiac rehabilitation.
- What is the potential effect of this intervention on patient activation and feelings of certainty and guidance.
Participants will:
- Be randomised in either intervention or control group
- Fill in a questionnaire at the start of their waiting period (after release from the hospital)
- Use the eHealth intervention during their waiting period (usually 2 to 6 weeks)(intervention group only)
- Fill in a questionnaire at the start of their rehabilitation
Researchers will compare intervention and control group to see if the intervention has improved patient activation and feelings of certainty and guidance.
Read the detailed description
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 (CR). 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. The goal of this randomised pilot study is to assess the feasibility of this tailored eHealth intervention for cardiac patients with a low SEP and explore its effect on patients activation, certainty and guidance compared to usual care. The study population consists of patients (>18 years) with a low SEP who are eligible for participation in CR and have been referred to CR by their cardiologist.
Patients will be enrolled in the intervention group based on randomization. The intervention group will use an eHealth application during the waiting period before CR 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 CR.
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
- Conditions
- Cardiac Disease
- Being tested
- CapriXpress
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapriXpressDevice
The app is a digital, tailored intervention aimed at activating patients during their waiting period between discharge from hospital and start of their cardiac rehabilitation by providing certainty and guidance. The goal of the intervention is to reach the end-goal: the start of the rehabilitation. Progression towards this end-goal is made automatically as time advances. The intervention provides guidance by providing the patient with a set of daily messages. These messages are pre-made by representatives of different disciplines within cardiac rehabilitation. The messages contain discipline-related information and suggestions as well as a perspective on peer experiences. Each day, the patient is free to choose which and the number of messages to engage with.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will use an eHealth application during the waiting period before cardiac rehabilitation starts. Receives: Device: CapriXpress |
| Control | No intervention | The control group will go through the usual waiting period before the start of cardiac rehabilitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the intervention
Acceptability will be measured using a self-designed questionnaire (9 items) based on the USE questionnaire.
Measured: During the entire waiting period (usually 2 to 6 weeks)
Use of the intervention
Use 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.
Measured: During the entire waiting period (usually 2 to 6 weeks)
Experience of the intervention
Experience will be determined based on a thematic analysis of several qualitative semi-structured interviews.
Measured: During the entire waiting period (usually 2 to 6 weeks)
Secondary outcomes (2)
Patient activation
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.
Measured: During the entire waiting period (usually 2 to 6 weeks)
Guidance and certainty
Feelings of certainty and guidance using a self-designed questionnaire (9 items).
Measured: During the entire waiting period (usually 2 to 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start8 Feb 2023
- Primary completion23 Jul 2023
- Study completion23 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. HJG (Rita) van den Berg-Emons, Erasmus Medical Center
- Investigators
- Rita van den Berg-Emons, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698121
- Sponsor's protocol ID
- NL81969.078.22
- Acronym
- PReCARE
- Status last verified
- Dec 2023
- First submitted
- 4 Jan 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Faber JS, Kraal JJ, Ter Hoeve N, Al-Dhahir I, Breeman LD, Chavannes NH, Evers AWM, Bussmann HBJ, Visch VT, van den Berg-Emons RJG. An eHealth intervention for patients with a low socioeconomic position during their waiting period preceding cardiac rehabilitation: a randomized feasibility study. Eur Heart J Digit Health. 2024 Nov 14;6(1):115-125. doi: 10.1093/ehjdh/ztae084. eCollection 2025 Jan.
PubMed 39846066
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PReCARE - Evaluation of a Preparatory eHealth Intervention for Patients With a Low SEP in Cardiac Rehabilitation: a Pilot Study.
- ClinicalTrials.gov ID
- NCT05698121
- Acronym / sponsor ID
- PReCARE / NL81969.078.22
- Conditions
- Cardiac Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 23 Jul 2023 (actual)
- Study completion
- 23 Jul 2023 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot study is to evaluate the feasibility of an eHealth intervention for cardiac patients during their waiting period before their rehabilitation.
The main questions it aims to answer are:
- What is the feasibility of an eHealth intervention designed for cardiac patients with a low socio-economic position during the waiting period before their cardiac rehabilitation.
- What is the potential effect of this intervention on patient activation and feelings of certainty and guidance.
Participants will:
- Be randomised in either intervention or control group
- Fill in a questionnaire at the start of their waiting period (after release from the hospital)
- Use the eHealth intervention during their waiting period (usually 2 to 6 weeks)(intervention group only)
- Fill in a questionnaire at the start of their rehabilitation
Researchers will compare intervention and control group to see if the intervention has improved patient activation and feelings of certainty and guidance.
Detailed description
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 (CR). 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. The goal of this randomised pilot study is to assess the feasibility of this tailored eHealth intervention for cardiac patients with a low SEP and explore its effect on patients activation, certainty and guidance compared to usual care. The study population consists of patients (>18 years) with a low SEP who are eligible for participation in CR and have been referred to CR by their cardiologist.
Patients will be enrolled in the intervention group based on randomization. The intervention group will use an eHealth application during the waiting period before CR 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 CR.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: CapriXpressThe intervention group will use an eHealth application during the waiting period before cardiac rehabilitation starts. |
| Control | No intervention | –The control group will go through the usual waiting period before the start of cardiac rehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient is eligible for participation in cardiac rehabilitation
- The patient has signed the standard rehabilitation agreement provided by the rehabilitation centre and has agreed to be contacted for research purposes
- The patient is aged 18 years or above
- The patient signs an informed consent form
- The patient is sufficient in the Dutch language
Key exclusion criteria (1 listed)
- Upon referral, the medical status of the patient is screened by a physician of the CR center. Patients with severe physical, psychological, or cognitive impairments will not be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapriXpressThe app is a digital, tailored intervention aimed at activating patients during their waiting period between discharge from hospital and start of their cardiac rehabilitation by providing certainty and guidance. The goal of the intervention is to reach the end-goal: the start of the rehabilitation. Progression towards this end-goal is made automatically as time advances. The intervention provides guidance by providing the patient with a set of daily messages. These messages are pre-made by representatives of different disciplines within cardiac rehabilitation. The messages contain discipline-related information and suggestions as well as a perspective on peer experiences. Each day, the patient is free to choose which and the number of messages to engage with. | Device | Intervention |
Primary outcome
Acceptability of the intervention
Time frame: During the entire waiting period (usually 2 to 6 weeks)
Acceptability will be measured using a self-designed questionnaire (9 items) based on the USE questionnaire.
Use of the intervention
Time frame: During the entire waiting period (usually 2 to 6 weeks)
Use 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.
Experience of the intervention
Time frame: During the entire waiting period (usually 2 to 6 weeks)
Experience will be determined based on a thematic analysis of several qualitative semi-structured interviews.
2 secondary outcomes
Patient activation
Time frame: During the entire waiting period (usually 2 to 6 weeks)
Guidance and certainty
Time frame: During the entire waiting period (usually 2 to 6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Derived from this study: PubMed 39846066Faber JS, Kraal JJ, Ter Hoeve N, Al-Dhahir I, Breeman LD, Chavannes NH, Evers AWM, Bussmann HBJ, Visch VT, van den Berg-Emons RJG. An eHealth intervention for patients with a low socioeconomic position during their waiting period preceding cardiac rehabilitation: a randomized feasibility study. Eur Heart J Digit Health. 2024 Nov 14;6(1):115-125. doi: 10.1093/ehjdh/ztae084. eCollection 2025 Jan.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita van den Berg-Emons principal investigator
Erasmus Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CapriXpress in people with Cardiac Disease, run by Erasmus Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the intervention (time frame: During the entire waiting period (usually 2 to 6 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05698121, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.