Heart FailureNCT06699446
The "Seamless" Patient:From Preoperative Preparation to Postoperative Rehabilitation
A study testing pre rehabilitation in people with Heart Failure, run by Hannover Medical School at 1 site in Germany.
Trial summary
The "seamless" patient: from preoperative preparation to postoperative rehabilitation. The effects of digital services for perioperative care of patients undergoing cardiac surgery will be investigated Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- pre rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 28 Jun 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient is capable of giving consent;
- planned, elective cardiac surgery (coronary bypass surgery and heart valve surgery incl. combination surgery). The planned surgery can be performed with or without a heart-lung machine.
- Minimally invasive procedures may also be explicitly included in the study.
Who cannot join
- Emergency care;
- congenital heart defects;
- age less than 18 years;
- patient unable to give consent;
- patient unable to perform simple physical training;
- high-risk surgery with a calculated Euroscore II of more than 8%.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jasmin S Hanke, PD contact
Germany1 site, 1 recruiting
- Recruiting
Medical School Hanover
Hanover, Lower Saxony, 30625
Bastian Schmack, PD, Schmack.Bastian@mh-hannover.de
Jasnin s Hanke, PD, Hanke.Jasmin@mh-hannover.de
About this study
Official title: The "Seamless" Patient: From Preoperative Preparation to Postoperative Rehabilitation
The "seamless" patient: from preoperative preparation to postoperative rehabilitation.
The effects of digital services for perioperative care of patients undergoing cardiac surgery will be investigated
Read the detailed description
Intervention by randomization in: G1. "Standard of care" Previous postal call-in without additional communication or special follow-up G2: Intensified patient education via classical communication channels as well as provision of information material for outpatient, preoperative pre-rehabilitation (respiratory training, exercise therapy). Establish an individualized rehabilitation plan and telephone postoperative communication (postoperative for Patient-Reported Experience Measures (PREMs) and Patient-Reported Outcome Measures (PROM) analysis) with the surgical center. G3: Intensified education on new media (mobile app) with outpatient preoperative rehabilitation (respiratory training, exercise therapy). Creation of an individualized rehabilitation plan and postoperative, two-way communication via mobileapp.
This project combines the establishment of outpatient pre-rehabilitation with the additional benefit of interrogating patient-reported outcome (PROs) with individualized rehabilitation. Through the improved exchange of information and the resulting more intensive care of patients alone, we hope not only to improve the quality of life, but also to reduce postoperative mortality and morbidity. The use of new techniques with the establishment of a mobile-based app should provide a decisive advantage in the effectiveness of the measures in this regard. The integration of secure, direct, and always-available communication channels will both improve the flow of information and enhance patients' sense of security in an increasingly fast-moving healthcare system.
Hypotheses:
- The intervention in G2 "classic forms of communication" does not significantly improve the primary and secondary endpoints compared to the control group G1.
- The intervention in G3 "next level" communication via app leads to a significant improvement of the primary and secondary endpoints compared to control group G1.
- The rate of exercise performance (in the prehabilitation and rehabilitation phases; % of days) is significantly higher in the G3 "next level" communication via app group compared to the G2 "classical forms of communication" group.
- Intervention in G2 "classical forms of communication" and G3 "next level" communication via app leads to significant improvement in PREMs compared to control group G1.
- The questionaires: EQ-VAS, PROMIS-10 and HSSI are equally suitable for mapping the health status of patients* in the postoperative course.
- The feedback rate (completion of the query) on health status is significantly higher for the questionaires EQ-VAS compared to questionaire PROMIS-10, questionaire HSSI and questionaire MLHFQ.
- In patients* who develop postoperative pericardial tamponade, pneumonia, or surgical access wound complication (bleeding/Dressler syndrome, infection/sepsis, wound dehiscence/infection, mechanical instability), Questionaire EQ-VAS scores drop significantly before diagnosis. The questionaire EQ-VAS is therefore suitable as a non-specific postoperative parameter for triggering early further diagnostics.
- Conditions
- Heart Failure
- Being tested
- pre rehabilitation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre rehabilitationOther
preoperative pre-rehabilitation (respiratory training, exercise therapy). Establish an individualized rehabilitation plan and postoperative communication via telephone or app
| Study group | Role | What they receive |
|---|---|---|
| Standard of care" | No intervention | Previous postal call-in without additional communication or special follow-up |
| Intensified patient education | Other | via classical communication channels as well as provision of information material for outpatient, preoperative pre-rehabilitation (respiratory training, exercise therapy). Establish an individualized rehabilitation plan and telephone postoperative communication (postoperative for Patient-Reported Experience Measures (PREMs) and Patient-Reported Outcome Measures (PROM) analysis) with the surgical center Receives: Other: pre rehabilitation |
| Intensified education on new media (mobile app) | Other | with outpatient preoperative rehabilitation (respiratory training, exercise therapy). Creation of an individualized rehabilitation plan and postoperative, two-way communication via mobileapp. Receives: Other: pre rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life of patient via questionnaire
via questionnaire
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start28 Jun 2023
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699446
- Sponsor's protocol ID
- 01VSF21036
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "Seamless" Patient: From Preoperative Preparation to Postoperative Rehabilitation
- ClinicalTrials.gov ID
- NCT06699446
- Acronym / sponsor ID
- 01VSF21036
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Nov 2024 (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 "seamless" patient: from preoperative preparation to postoperative rehabilitation.
The effects of digital services for perioperative care of patients undergoing cardiac surgery will be investigated
Detailed description
Intervention by randomization in: G1. "Standard of care" Previous postal call-in without additional communication or special follow-up G2: Intensified patient education via classical communication channels as well as provision of information material for outpatient, preoperative pre-rehabilitation (respiratory training, exercise therapy). Establish an individualized rehabilitation plan and telephone postoperative communication (postoperative for Patient-Reported Experience Measures (PREMs) and Patient-Reported Outcome Measures (PROM) analysis) with the surgical center. G3: Intensified education on new media (mobile app) with outpatient preoperative rehabilitation (respiratory training, exercise therapy). Creation of an individualized rehabilitation plan and postoperative, two-way communication via mobileapp.
This project combines the establishment of outpatient pre-rehabilitation with the additional benefit of interrogating patient-reported outcome (PROs) with individualized rehabilitation. Through the improved exchange of information and the resulting more intensive care of patients alone, we hope not only to improve the quality of life, but also to reduce postoperative mortality and morbidity. The use of new techniques with the establishment of a mobile-based app should provide a decisive advantage in the effectiveness of the measures in this regard. The integration of secure, direct, and always-available communication channels will both improve the flow of information and enhance patients' sense of security in an increasingly fast-moving healthcare system.
Hypotheses:
- The intervention in G2 "classic forms of communication" does not significantly improve the primary and secondary endpoints compared to the control group G1.
- The intervention in G3 "next level" communication via app leads to a significant improvement of the primary and secondary endpoints compared to control group G1.
- The rate of exercise performance (in the prehabilitation and rehabilitation phases; % of days) is significantly higher in the G3 "next level" communication via app group compared to the G2 "classical forms of communication" group.
- Intervention in G2 "classical forms of communication" and G3 "next level" communication via app leads to significant improvement in PREMs compared to control group G1.
- The questionaires: EQ-VAS, PROMIS-10 and HSSI are equally suitable for mapping the health status of patients* in the postoperative course.
- The feedback rate (completion of the query) on health status is significantly higher for the questionaires EQ-VAS compared to questionaire PROMIS-10, questionaire HSSI and questionaire MLHFQ.
- In patients* who develop postoperative pericardial tamponade, pneumonia, or surgical access wound complication (bleeding/Dressler syndrome, infection/sepsis, wound dehiscence/infection, mechanical instability), Questionaire EQ-VAS scores drop significantly before diagnosis. The questionaire EQ-VAS is therefore suitable as a non-specific postoperative parameter for triggering early further diagnostics.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of care" | No intervention | –Previous postal call-in without additional communication or special follow-up |
| Intensified patient education | Other | Other: pre rehabilitationvia classical communication channels as well as provision of information material for outpatient, preoperative pre-rehabilitation (respiratory training, exercise therapy). Establish an individualized rehabilitation plan and telephone postoperative communication (postoperative for Patient-Reported Experience Measures (PREMs) and Patient-Reported Outcome Measures (PROM) analysis) with the surgical center |
| Intensified education on new media (mobile app) | Other | Other: pre rehabilitationwith outpatient preoperative rehabilitation (respiratory training, exercise therapy). Creation of an individualized rehabilitation plan and postoperative, two-way communication via mobileapp. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is capable of giving consent;
- planned, elective cardiac surgery (coronary bypass surgery and heart valve surgery incl. combination surgery). The planned surgery can be performed with or without a heart-lung machine.
- Minimally invasive procedures may also be explicitly included in the study.
Key exclusion criteria (6 listed)
- Emergency care;
- congenital heart defects;
- age less than 18 years;
- patient unable to give consent;
- patient unable to perform simple physical training;
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 |
|---|---|---|
| pre rehabilitationpreoperative pre-rehabilitation (respiratory training, exercise therapy). Establish an individualized rehabilitation plan and postoperative communication via telephone or app | Other | Intensified education on new media (mobile app), Intensified patient education |
Primary outcome
Quality of life of patient via questionnaire
Time frame: 6 month
via questionnaire
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- 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.
Jasmin S Hanke, PD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre rehabilitation in people with Heart Failure, run by Hannover Medical School at 1 site in Germany.
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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 21 Nov 2024. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bastian Schmack, PD (0511-532-3452, Schmack.bastian@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life of patient via questionnaire (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2024.