Heart FailureADMINISTERNCT05413447
Assessment of Digital Consultations on Clinical Impact and Efficiency
A study testing Digital consult in people with Heart Failure, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 5 sites in Netherlands.
Trial summary
Healthcare workers have a high workload as compared to other sectors and this burden is projected to increase due to an aging society. It is and will in the future be challenging to deliver optimal HF care because of personnel shortages, the high costs of healthcare, intensive GDMT uptitration schedules, and an… 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?
- Digital consult
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesNetherlands
- Study dates
- 1 Sep 2022to 6 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
- HFrEF
Who cannot join
- Patients not in possession of any attributes to perform the consults digitally
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
Amsterdam UMC, location AMC
Amsterdam, North Holland, 1105 AZ
Cardiology Centers of the Netherlands
Amsterdam, North Holland, 1105 BJ
Amsterdam UMC, location VUmc
Amsterdam
Red Cross Hospital
Beverwijk
UMC Utrecht
Utrecht, 3584 CX
About this study
Official title: Assessment of Digital Consultations on Clinical Impact and Efficiency Using a RCT (ADMINISTER) Trial
Healthcare workers have a high workload as compared to other sectors and this burden is projected to increase due to an aging society. It is and will in the future be challenging to deliver optimal HF care because of personnel shortages, the high costs of healthcare, intensive GDMT uptitration schedules, and an epidemic rise in HF patients.This study aims to evaluate the impact of digital consultations (DC) on efficiency and clinical impact in heart failure (HF) patients.
A randomized controlled trial on multifaceted digital consults including 1) digital data sharing (e.g. exchange of pharmacotherapy use, home measured vital signs, etc), 2) patient education via an eLearning, and 3) digital guideline recommendations to treating physicians. Included patients will be randomly (1:1) assigned to the intervention group or standard care.
The ADMINISTER trial is expected to offer the first robust randomized controlled multicenter data of GDMT prescription rates, time till full GDMT optimization, time spent on healthcare, patient satisfaction and quality of life of digital consults in GDMT optimization.
Read the detailed description
Introduction: Many heart failure (HF) patients do not receive optimal guideline-directed medical therapy (GDMT) despite clear benefit on morbidity and mortality outcomes. Digital consultations (DC) have the potential to improve efficiency on GDMT optimization to serve the growing HF population. Hence, the investigator initiated ADMINISTER trial was designed as a pragmatic multicenter randomized controlled trial to evaluate efficacy and safety of DC in patients on HF treatment.
Methods: Patients (n = 150) diagnosed with HF with a reduced ejection fraction (HFrEF) will be randomized to DC or standard care (1:1). The intervention group receive multifaceted digital consults including 1) digital data sharing (e.g. exchange of pharmacotherapy use, home measured vital signs, etc), 2) patient education via an eLearning, and 3) digital guideline recommendations to treating physicians. The consultations are performed remotely unless there is an indication to perform the consult physically. The primary outcome is the GDMT prescription rate score, secondary outcomes include time till full GDMT optimization, patient and clinician satisfaction, time spent on healthcare, and Kansas City Cardiomyopathy questionnaire. Results will be reported in accordance to the CONSORT statement.
Conclusion: The ADMINISTER trial will offer the first randomized controlled data on GDMT prescription rates, time till full GDMT optimization, time spent on healthcare, quality of life, and patient and clinician satisfaction of the multifaceted patient and clinician targeted DC for GDMT optimization.
- Conditions
- Heart Failure
- Being tested
- Digital consult
- Keywords
- Digital consultations, GDMT optimization, HFrEF
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital consultCombination product
Consultations will be prepared digitally using the Mychart patient portal, an elearning and questionnaires. The consultation takes place via Teams.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving digital consultations | Experimental | The intervention group receive multifaceted digital consults including 1) digital data sharing (e.g. exchange of pharmacotherapy use, home measured vital signs, etc), 2) patient education via an eLearning, and 3) digital guideline recommendations to treating physicians. The consultations are performed remotely unless there is an indication to perform the consult physically. Receives: Combination Product: Digital consult |
| Standard care | No intervention | If the patient is drawn into the control group the patient will receive standard care. Clinicians are free to use all standard modes of communication, and are not specifically encouraged to use remote types of communication. The clinicians are not informed about the assignment of a patient to the control group to optimally capture remote practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescription rate of ACE/ARNI according to the guidelines
The treatment with ACE/ARNI in accordance to the guideline is measured at baseline and within 4 weeks after the consult. The received dose is divided by the target dose per timepoint. The score will range between a maximum of 1 (corresponding with a treatment according to the guidelines) and a minimum of 0 (corresponding with not administering the medicine). Significant differences between the two groups are determined at both timepoints.
Measured: 12 weeks after baseline
Prescription rate of betablockers according to the guidelines
The treatment with betablockers in accordance to the guideline is measured at baseline and within 4 weeks after the consult. The received dose is divided by the target dose per timepoint. The score will range between a maximum of 1 (corresponding with a treatment according to the guidelines) and a minimum of 0 (corresponding with not administering the medicine). Significant differences between the two groups are determined at both timepoints.
Measured: 12 weeks after baseline
Prescription rate of MRA according to the guidelines
The treatment with MRA in accordance to the guideline is measured at baseline and within 4 weeks after the consult. The received dose is divided by the target dose per timepoint. The score will range between a maximum of 1 (corresponding with a treatment according to the guidelines) and a minimum of 0 (corresponding with not administering the medicine). Significant differences between the two groups are determined at both timepoints.
Measured: 12 weeks after baseline
Prescription rate of SGLT2i according to the guidelines
The treatment with SGLT2i in accordance to the guideline is measured at baseline and within 4 weeks after the consult. The received dose is divided by the target dose per timepoint. The score will range between a maximum of 1 (corresponding with a treatment according to the guidelines) and a minimum of 0 (corresponding with not administering the medicine). Significant differences between the two groups are determined at both timepoints.
Measured: 12 weeks after baseline
Prescription rate of periodic screening of iron insufficiency
It is checked whether periodic (once a year) screening of iron deficiency is performed. And if the patient had iron insufficiency; it is checked whether the patient is receiving intravenous iron administration. Iron insufficiency is defined as ferritin <100 ng/ml or ferritin < 300 ng/ml with transferrin saturation (TSAT) < 20%. For patients with periodic screening for iron deficiency and if appropriate supplementation, a score of 1 was assigned. Other patients will receive a score of 0. Significant differences between groups will be assessed at both timepoints.
Measured: 12 weeks after baseline
Secondary outcomes (5)
Patient satisfaction
Patient satisfaction measured with the Net Promotor Score. This is a score in which the patient is asked to give a value between 1 and 10 indicating the likelihood that he/she will recommend the care given at the AUMC to other patients (1 equals unlikely and 10 likely).
Measured: At baseline and 12 weeks after the baseline recording
Difference in summary score of Kansas city cardiomyopathy questionnaire
Worsening of experienced HF, assessed with the "Kansas city cardiomyopathy questionnaire". This will lead to a summary score indicating the severity of the experienced heart failure. This score will range from 0 indicating a bad outcome of the questionnaire to 100 indicating a good outcome.
Measured: At baseline and 12 weeks after the baseline recording
Time spend on healthcare
The amount of time the patient spends on healthcare.
Measured: 12 weeks after baseline
Amount of hospitalizations per patient
Amount of hospitalizations is recorded for each patient and group differences between the treatment and control group are determined
Measured: Hospitalization are recorded from baseline until 12 weeks after baseline
Healthcare satisfaction
Clinicians will be asked to rate their satisfaction using the Net Promotor Score. This is a score in which the clinician is asked to give a value between 1 and 10 indicating the likelihood that he/she will recommend the remote care with digital consultations to other collegues (1 equals unlikely and 10 likely).
Measured: 12 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start1 Sep 2022
- Primary completion6 Jun 2024
- Study completion6 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 Heart FailureStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Schuuring, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413447
- Sponsor's protocol ID
- 123456567
- Acronym
- ADMINISTER
- Status last verified
- Jul 2024
- First submitted
- 30 May 2022
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Man JP, Koole MAC, Meregalli PG, Handoko ML, Stienen S, de Lange FJ, Winter MM, Schijven MP, Kok WEM, Kuipers DI, van der Harst P, Asselbergs FW, Zwinderman AH, Dijkgraaf MGW, Chamuleau SAJ, Schuuring MJ. Digital consults in heart failure care: a randomized controlled trial. Nat Med. 2024 Oct;30(10):2907-2913. doi: 10.1038/s41591-024-03238-6. Epub 2024 Aug 31.
PubMed 39217271
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Digital Consultations on Clinical Impact and Efficiency Using a RCT (ADMINISTER) Trial
- ClinicalTrials.gov ID
- NCT05413447
- Acronym / sponsor ID
- ADMINISTER / 123456567
- Conditions
- Heart Failure
- Keywords
- Digital consultations, GDMT optimization, HFrEF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 10 Jun 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.
Healthcare workers have a high workload as compared to other sectors and this burden is projected to increase due to an aging society. It is and will in the future be challenging to deliver optimal HF care because of personnel shortages, the high costs of healthcare, intensive GDMT uptitration schedules, and an epidemic rise in HF patients.This study aims to evaluate the impact of digital consultations (DC) on efficiency and clinical impact in heart failure (HF) patients.
A randomized controlled trial on multifaceted digital consults including 1) digital data sharing (e.g. exchange of pharmacotherapy use, home measured vital signs, etc), 2) patient education via an eLearning, and 3) digital guideline recommendations to treating physicians. Included patients will be randomly (1:1) assigned to the intervention group or standard care.
The ADMINISTER trial is expected to offer the first robust randomized controlled multicenter data of GDMT prescription rates, time till full GDMT optimization, time spent on healthcare, patient satisfaction and quality of life of digital consults in GDMT optimization.
Detailed description
Introduction: Many heart failure (HF) patients do not receive optimal guideline-directed medical therapy (GDMT) despite clear benefit on morbidity and mortality outcomes. Digital consultations (DC) have the potential to improve efficiency on GDMT optimization to serve the growing HF population. Hence, the investigator initiated ADMINISTER trial was designed as a pragmatic multicenter randomized controlled trial to evaluate efficacy and safety of DC in patients on HF treatment.
Methods: Patients (n = 150) diagnosed with HF with a reduced ejection fraction (HFrEF) will be randomized to DC or standard care (1:1). The intervention group receive multifaceted digital consults including 1) digital data sharing (e.g. exchange of pharmacotherapy use, home measured vital signs, etc), 2) patient education via an eLearning, and 3) digital guideline recommendations to treating physicians. The consultations are performed remotely unless there is an indication to perform the consult physically. The primary outcome is the GDMT prescription rate score, secondary outcomes include time till full GDMT optimization, patient and clinician satisfaction, time spent on healthcare, and Kansas City Cardiomyopathy questionnaire. Results will be reported in accordance to the CONSORT statement.
Conclusion: The ADMINISTER trial will offer the first randomized controlled data on GDMT prescription rates, time till full GDMT optimization, time spent on healthcare, quality of life, and patient and clinician satisfaction of the multifaceted patient and clinician targeted DC for GDMT optimization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Patients receiving digital consultations | Experimental | Combination Product: Digital consultThe intervention group receive multifaceted digital consults including 1) digital data sharing (e.g. exchange of pharmacotherapy use, home measured vital signs, etc), 2) patient education via an eLearning, and 3) digital guideline recommendations to treating physicians. The consultations are performed remotely unless there is an indication to perform the consult physically. |
| Standard care | No intervention | –If the patient is drawn into the control group the patient will receive standard care. Clinicians are free to use all standard modes of communication, and are not specifically encouraged to use remote types of communication. The clinicians are not informed about the assignment of a patient to the control group to optimally capture remote practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HFrEF
Key exclusion criteria (1 listed)
- Patients not in possession of any attributes to perform the consults digitally
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 |
|---|---|---|
| Digital consultConsultations will be prepared digitally using the Mychart patient portal, an elearning and questionnaires. The consultation takes place via Teams. | Combination product | Patients receiving digital consultations |
Primary outcome
Prescription rate of ACE/ARNI according to the guidelines
Time frame: 12 weeks after baseline
The treatment with ACE/ARNI in accordance to the guideline is measured at baseline and within 4 weeks after the consult. The received dose is divided by the target dose per timepoint. The score will range between a maximum of 1 (corresponding with a treatment according to the guidelines) and a minimum of 0 (corresponding with not administering the medicine). Significant differences between the two groups are determined at both timepoints.
Prescription rate of betablockers according to the guidelines
Time frame: 12 weeks after baseline
The treatment with betablockers in accordance to the guideline is measured at baseline and within 4 weeks after the consult. The received dose is divided by the target dose per timepoint. The score will range between a maximum of 1 (corresponding with a treatment according to the guidelines) and a minimum of 0 (corresponding with not administering the medicine). Significant differences between the two groups are determined at both timepoints.
Prescription rate of MRA according to the guidelines
Time frame: 12 weeks after baseline
The treatment with MRA in accordance to the guideline is measured at baseline and within 4 weeks after the consult. The received dose is divided by the target dose per timepoint. The score will range between a maximum of 1 (corresponding with a treatment according to the guidelines) and a minimum of 0 (corresponding with not administering the medicine). Significant differences between the two groups are determined at both timepoints.
Prescription rate of SGLT2i according to the guidelines
Time frame: 12 weeks after baseline
The treatment with SGLT2i in accordance to the guideline is measured at baseline and within 4 weeks after the consult. The received dose is divided by the target dose per timepoint. The score will range between a maximum of 1 (corresponding with a treatment according to the guidelines) and a minimum of 0 (corresponding with not administering the medicine). Significant differences between the two groups are determined at both timepoints.
Prescription rate of periodic screening of iron insufficiency
Time frame: 12 weeks after baseline
It is checked whether periodic (once a year) screening of iron deficiency is performed. And if the patient had iron insufficiency; it is checked whether the patient is receiving intravenous iron administration. Iron insufficiency is defined as ferritin <100 ng/ml or ferritin < 300 ng/ml with transferrin saturation (TSAT) < 20%. For patients with periodic screening for iron deficiency and if appropriate supplementation, a score of 1 was assigned. Other patients will receive a score of 0. Significant differences between groups will be assessed at both timepoints.
5 secondary outcomes
Patient satisfaction
Time frame: At baseline and 12 weeks after the baseline recording
Difference in summary score of Kansas city cardiomyopathy questionnaire
Time frame: At baseline and 12 weeks after the baseline recording
Time spend on healthcare
Time frame: 12 weeks after baseline
Amount of hospitalizations per patient
Time frame: Hospitalization are recorded from baseline until 12 weeks after baseline
Healthcare satisfaction
Time frame: 12 weeks after baseline
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 23 Jul 2024.
- Derived from this study: PubMed 39217271Man JP, Koole MAC, Meregalli PG, Handoko ML, Stienen S, de Lange FJ, Winter MM, Schijven MP, Kok WEM, Kuipers DI, van der Harst P, Asselbergs FW, Zwinderman AH, Dijkgraaf MGW, Chamuleau SAJ, Schuuring MJ. Digital consults in heart failure care: a randomized controlled trial. Nat Med. 2024 Oct;30(10):2907-2913. doi: 10.1038/s41591-024-03238-6. Epub 2024 Aug 31.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital consult in people with Heart Failure, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 5 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 1 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 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Prescription rate of ACE/ARNI according to the guidelines (time frame: 12 weeks after baseline). The study lists 5 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 NCT05413447, 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 23 Jul 2024.