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NCT04399616: ATDOM_SP
Map of Risks in Home Care From Primary Health Care, an Approach From Health Care Quality.
NA trial testing Risk Map in Community Health Services in 400 participants. Status unknown.
1 June 2025
Quick facts
| Lead sponsor | Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 400 |
| Start date | 1 January 2025 |
| Primary completion | 1 June 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Risk Map
Conditions studied
- Community Health Services — all drugs for Community Health Services →
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina — full company profile →
Who can join
18 and older, any sex, with Community Health Services. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Home health care is very complex. The registration of many disassembled information makes it difficult to interpret and does not allow the identification of critical areas for risk management. Hypothesis / Research question: The availability of a risk map, with visual alerts to identify the critical areas, will facilitate the implementation of safe practices and improve the safety of patients included in the DOMicillary care program (ATDOM). Objectives: To design and evaluate the effectiveness of the availability of a Visual Risks Map (MRV) in the computerized medical histories of ATDOM patients in the improvement of their safety and quality of life.(QL). Methods: Once MRV is designed, the investigators will conduct a randomized clinical trial by conglomerates (Primary Care centers) to evaluate whether the fact of having this MRV (intervention) in the medical histories of ATDOM patients reduces avoidable income, falls and wounds and improves QL. Analysis plan: Baseline description: socio-demographic characteristics, risk's levels in the different areas and other covariates in the control and intervention groups. Chi-square test to compare frequency of outcomes between control and intervention groups. Cox regression model to estimate time until the outcomes appear, adjusting for the different variables. Expected results: The frequency of avoidable hospital admissions / emergencies' visits, falls and sores / infections will be significantly lower in the group of patients who have MRV in their clinical histories. Their qL wil be better. Applicability and Relevance: It is a feasible and easy-to-implement project. It provides a practical utility for a lot of information that the investigators record and affects a key aspect of quality of care.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Design, Implementation, and Evaluation of Healthcare Visual Map Tool for Health Workers to Improve Quality of Life of Home Care Patients: Study Protocol.
Hernández-Vidal N, Pujol-Vidal M, Mengíbar-García Y, Ayala-Villuendas D, et al · · 2025 · PMID 40150476 · DOI 10.3390/healthcare13060626
Verify or expand the search:
- PubMed search for NCT04399616
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04399616 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Last refreshed: 8 May 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/NCT04399616.
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