Valvular Heart DiseaseNCT05179278
Impact of a PROgram of Cardiovascular Nurse interventionS in a VALVular haEmodynamic Unit (PROCESS-VALVE) on Quality Indicators: a Quasi-experimental Ambispective Study
A study testing Post-surgical nurse follow-up in people with Valvular Heart Disease, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The objective of this study is to evaluate the impact of a program of presurgical and postsurgical nurse interventions (PROCESS-VALVE) on quality indicators of the health of patients undergoing percutaneous valve procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valvular Heart Disease
- What is being tested?
- Post-surgical nurse follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteSpain
- Study dates
- 25 Feb 2021to 1 Jun 2024
- 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
- Patients accepted for Heart-Team for percutaneous treatment aortic stenosis/insufficiency and mitral or tricuspid regurgitation
- Patients visited in the pre-surgical nursing consultation
Who cannot join
- Patients with language barrier
- Patients undergoing emergency surgery for percutaneous treatment aortic stenosis/insufficiency and mitral or tricuspid regurgitation
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate the impact of a program of presurgical and postsurgical nurse interventions (PROCESS-VALVE) on quality indicators of the health of patients undergoing percutaneous valve procedures. (waiting times, patient satisfaction, admission times, hospital readmission, mortality, intrahospital complications and nosocomial infections). Design of the study is an ambispective quasi-experimental study. For the control group, data will be collected retrospectively from patients undergoing percutaneous valve procedures who did not receive pre- or postsurgical consultations. The intervention group will comprise those patients who agree to participate in the study and the haemodynamic nurse valve consultation program (PROCESS-VALVE). In addition, the investigators will assess whether a face-to-face postsurgical consultation improved quality indicators compared to postsurgical telephone consultation; for this, a sub-study will be carried out comparing face-to-face or telephone postsurgical follow-up by means of a randomised controlled clinical trial with simple blinding in the intervention group. Study area will be at the Hemodynamic Unit of the Hospital de la Santa Creu i Sant Pau and the study population are chosen patients for percutaneous valvular intervention who attend the pre-surgical consultation at our center. Dependent variable will be the indicators cited in the study aim and the independent variable will be the pre-surgical and post-surgical consultation. In pre-surgical consultation will be done a patient recruitment and will collect sociodemographic and clinical data. At patient will be done an individualized interview with an Ad-Hoc questionnaire and to collect fragility level of study and level of planned connections. In the subsequent follow-up, all pacients will receive a follow-up visit and collect satisfaction and quality indicators. But this pacients will be randomized to telephone follow-up or face-to-face follow up. Sample size has been calculated in 194 to be distributed equally in both groups and the clinical trials groups will be formed by 94 patients in each group The protocol has been modified to an ambispective quasi-experimental study with a subsequent randomization for the type of follow-up (telephone vs face-to-face) due to organizational changes in the participant center.
- Conditions
- Valvular Heart Disease
- Being tested
- Post-surgical nurse follow-up
- Keywords
- valvular heart disease, nurse consultation, health indicators, post-surgical follow-up
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-surgical nurse follow-upOther
Follow-up face-to-face consultation or follow-up telephone consultation a month after the intervention and telephone consultation at one year
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: post-surgical face-to-face follow up consultation | Experimental | Not described Receives: Other: Post-surgical nurse follow-up |
| Control Group: post-surgical telephone follow up consultation | Experimental | Not described Receives: Other: Post-surgical nurse follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waiting time
Time since Heart-team accepted until the intervention
Measured: Pre-intervention
Satisfaction assessed by SUCMA 14 Questionnaire
Use of an adaptation Sucma 14 Questionnaire (in english Questionnaire Satisfaction of Users of Major Ambulatory Surgery). This scale is former for 14 independent questions with 5 options response (likert scale)
Measured: One mounth after intervention
Satisfaction assessed by SUCMA 14 Questionnaire
Use of an adaptation Sucma 14 Questionnaire (in english Questionnaire Satisfaction of Users of Major Ambulatory Surgery). This scale is former for 14 independent questions with 5 options response (likert scale)
Measured: One year after intervention
Admission time
Time since intervention until hospital discharge
Measured: During hospital admission ( until the last day of admission)
Rate of Hospital readmission
Hospital readminission after the intervention for cardiac reasons
Measured: One mounth after intervention
Rate of Hospital readmission
Hospital readminission after the intervention for cardiac reasons
Measured: One year after intervention
Rate of Mortality
Mortality for all reasons (cardiac or other reason)
Measured: Into admission time
Rate of Mortality
Mortality for all reasons (cardiac or other reason)
Measured: One mounth after intervention
Rate of Mortality
Mortality for all reasons (cardiac or other reason)
Measured: One year after intervention
Rate of Intrahospital complications
Procedure complications (vascular, stroke and cardiac complication)
Measured: Into admission time
Rate of Intrahospital complications
Procedure complications (vascular, stroke and cardiac complication)
Measured: One mounth after intervention
Rate of Intrahospital complications
Procedure complications (vascular, stroke and cardiac complication)
Measured: One year after intervention
Rate of Nosocomial infection
Infection adquired during hospital admission
Measured: During hospital admission (until the last day of admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start25 Feb 2021
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
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 Valvular Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179278
- Sponsor's protocol ID
- IIBSP-CEH-2020-140
- Status last verified
- May 2023
- First submitted
- 5 Aug 2021
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valverde Bernal J, Martinez-Soler F, Berga Congost G, Martinez Perez J, Asmarats L, Moreno Arroyo C. Impact of a PROgram of Cardiovascular nursE interventionS in a VALVular haEmodynamic Unit (PROCESS-VALVE) on Quality Indicators: A Quasi-Experimental Ambispective Study. Int J Gen Med. 2023 Sep 20;16:4257-4265. doi: 10.2147/IJGM.S412369. eCollection 2023.
PubMed 37750105
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a PROgram of Cardiovascular Nurse interventionS in a VALVular haEmodynamic Unit (PROCESS-VALVE) on Quality Indicators: a Quasi-experimental Ambispective Study
- ClinicalTrials.gov ID
- NCT05179278
- Acronym / sponsor ID
- IIBSP-CEH-2020-140
- Conditions
- Valvular Heart Disease
- Keywords
- valvular heart disease, nurse consultation, health indicators, post-surgical follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 5 Jan 2022 (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 objective of this study is to evaluate the impact of a program of presurgical and postsurgical nurse interventions (PROCESS-VALVE) on quality indicators of the health of patients undergoing percutaneous valve procedures. (waiting times, patient satisfaction, admission times, hospital readmission, mortality, intrahospital complications and nosocomial infections). Design of the study is an ambispective quasi-experimental study. For the control group, data will be collected retrospectively from patients undergoing percutaneous valve procedures who did not receive pre- or postsurgical consultations. The intervention group will comprise those patients who agree to participate in the study and the haemodynamic nurse valve consultation program (PROCESS-VALVE). In addition, the investigators will assess whether a face-to-face postsurgical consultation improved quality indicators compared to postsurgical telephone consultation; for this, a sub-study will be carried out comparing face-to-face or telephone postsurgical follow-up by means of a randomised controlled clinical trial with simple blinding in the intervention group. Study area will be at the Hemodynamic Unit of the Hospital de la Santa Creu i Sant Pau and the study population are chosen patients for percutaneous valvular intervention who attend the pre-surgical consultation at our center. Dependent variable will be the indicators cited in the study aim and the independent variable will be the pre-surgical and post-surgical consultation. In pre-surgical consultation will be done a patient recruitment and will collect sociodemographic and clinical data. At patient will be done an individualized interview with an Ad-Hoc questionnaire and to collect fragility level of study and level of planned connections. In the subsequent follow-up, all pacients will receive a follow-up visit and collect satisfaction and quality indicators. But this pacients will be randomized to telephone follow-up or face-to-face follow up. Sample size has been calculated in 194 to be distributed equally in both groups and the clinical trials groups will be formed by 94 patients in each group The protocol has been modified to an ambispective quasi-experimental study with a subsequent randomization for the type of follow-up (telephone vs face-to-face) due to organizational changes in the participant center.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: post-surgical face-to-face follow up consultation | Experimental | Other: Post-surgical nurse follow-up |
| Control Group: post-surgical telephone follow up consultation | Experimental | Other: Post-surgical nurse follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients accepted for Heart-Team for percutaneous treatment aortic stenosis/insufficiency and mitral or tricuspid regurgitation
- Patients visited in the pre-surgical nursing consultation
Key exclusion criteria (2 listed)
- Patients with language barrier
- Patients undergoing emergency surgery for percutaneous treatment aortic stenosis/insufficiency and mitral or tricuspid regurgitation
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 |
|---|---|---|
| Post-surgical nurse follow-upFollow-up face-to-face consultation or follow-up telephone consultation a month after the intervention and telephone consultation at one year | Other | Control Group: post-surgical telephone follow up consultation, Intervention Group: post-surgical face-to-face follow up consultation |
Primary outcome
Waiting time
Time frame: Pre-intervention
Time since Heart-team accepted until the intervention
Satisfaction assessed by SUCMA 14 Questionnaire
Time frame: One mounth after intervention
Use of an adaptation Sucma 14 Questionnaire (in english Questionnaire Satisfaction of Users of Major Ambulatory Surgery). This scale is former for 14 independent questions with 5 options response (likert scale)
Satisfaction assessed by SUCMA 14 Questionnaire
Time frame: One year after intervention
Use of an adaptation Sucma 14 Questionnaire (in english Questionnaire Satisfaction of Users of Major Ambulatory Surgery). This scale is former for 14 independent questions with 5 options response (likert scale)
Admission time
Time frame: During hospital admission ( until the last day of admission)
Time since intervention until hospital discharge
Rate of Hospital readmission
Time frame: One mounth after intervention
Hospital readminission after the intervention for cardiac reasons
Rate of Hospital readmission
Time frame: One year after intervention
Hospital readminission after the intervention for cardiac reasons
Rate of Mortality
Time frame: Into admission time
Mortality for all reasons (cardiac or other reason)
Rate of Mortality
Time frame: One mounth after intervention
Mortality for all reasons (cardiac or other reason)
Rate of Mortality
Time frame: One year after intervention
Mortality for all reasons (cardiac or other reason)
Rate of Intrahospital complications
Time frame: Into admission time
Procedure complications (vascular, stroke and cardiac complication)
Rate of Intrahospital complications
Time frame: One mounth after intervention
Procedure complications (vascular, stroke and cardiac complication)
Rate of Intrahospital complications
Time frame: One year after intervention
Procedure complications (vascular, stroke and cardiac complication)
Rate of Nosocomial infection
Time frame: During hospital admission (until the last day of admission)
Infection adquired during hospital admission
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 18 Nov 2025.
- Derived from this study: PubMed 37750105Valverde Bernal J, Martinez-Soler F, Berga Congost G, Martinez Perez J, Asmarats L, Moreno Arroyo C. Impact of a PROgram of Cardiovascular nursE interventionS in a VALVular haEmodynamic Unit (PROCESS-VALVE) on Quality Indicators: A Quasi-Experimental Ambispective Study. Int J Gen Med. 2023 Sep 20;16:4257-4265. doi: 10.2147/IJGM.S412369. eCollection 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-surgical nurse follow-up in people with Valvular Heart Disease, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 2 inclusion and 2 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 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Waiting time (time frame: Pre-intervention). The study lists 13 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 NCT05179278, 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 18 Nov 2025.