Cardiac Disease Clinical Trial
— PReCAREOfficial title:
PReCARE - Evaluation of a Preparatory eHealth Intervention for Patients With a Low SEP in Cardiac Rehabilitation: a Pilot Study.
Verified date | December 2023 |
Source | Erasmus Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | July 23, 2023 |
Est. primary completion date | July 23, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Capri Hartrevalidatie | Den Haag | Zuid Holland |
Netherlands | Capri Hartrevalidatie | Rotterdam | Zuid-Holland |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acceptability of the intervention | Acceptability will be measured using a self-designed questionnaire (9 items) based on the USE questionnaire. | During the entire waiting period (usually 2 to 6 weeks) | |
Primary | 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. | During the entire waiting period (usually 2 to 6 weeks) | |
Primary | Experience of the intervention | Experience will be determined based on a thematic analysis of several qualitative semi-structured interviews. | During the entire waiting period (usually 2 to 6 weeks) | |
Secondary | 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. | During the entire waiting period (usually 2 to 6 weeks) | |
Secondary | Guidance and certainty | Feelings of certainty and guidance using a self-designed questionnaire (9 items). | During the entire waiting period (usually 2 to 6 weeks) |
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