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NCT06616129: PRIME
A Study Protocol for Research Investigating How Geriatric Risk Assessment and Shared Decision-making Conversations Affect Treatment Decisions and Quality of Life in Patients Eligible for Open-heart Surgery.
NA trial testing Geriatric assessment in Frail Elderly Persons in 70 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | University Medical Center Groningen |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 70 |
| Start date | 4 April 2022 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Geriatric assessment
- Shared decision-making conversation
Conditions studied
- Frail Elderly Persons — all drugs for Frail Elderly Persons →
- Cardiac Surgery — all drugs for Cardiac Surgery →
Sponsor
University Medical Center Groningen
Who can join
70 and older, any sex, with Frail Elderly Persons or Cardiac Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this study is to determine whether intervention by the PRIME clinic influences cardiac treatment decisions, as well as patients quality of life and healthcare utilization. The main questions this study aims to answer are: * Does PRIME consultation influence treatment recommendations? * Does a personalized treatment plan for cardiac patients influence health-related quality of life? * Does a personalized treatment plan influence healthcare costs (in terms of quality-adjusted life years)? Participants will: * Visit the PRIME clinic once * Complete quality of life questionnaires twice * Track their healthcare usage over the course of a year and complete a corresponding questionnaire four times.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06616129
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06616129 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Medical Center Groningen
- Last refreshed: 27 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06616129.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing