Detection of Anemizations in Primary Care.

Anemia Clinical Trial

— ANHEMOG  

Official title:

Early Detection of Anemizations in Primary Care Using Hemoglobinometer: Randomized Clinical Trial Protocol.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04757909
• Other study ID #: 4R17/013
• Secondary ID: 4R18/084R17/013
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2017
• Est. completion date: December 2023

Study information

• Verified date: February 2021
• Source: Jordi Gol i Gurina Foundation
• Contact: Boris Trenado Luengo, RN
• Phone: 0034 93384 24 25
• Email: btrenado.mn.ics[@]gencat.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: To evaluate the effect of the use of the hemoglobinometer in primary care on the clinical results of patients with chronic anemia.

Methods: The ANHEMOG study is a randomized controlled trial with two parallel arms, intervention and control. It was approved at december 11, 2017. The study randomizes 138 patients with chronic anemia. In the intervention arm, a monthly capillary hemoglobin measurement will be performed with a hemoglobinometer. If a decrease in hemoglobin concentration is detected, an existing transfusion circuit will be followed. Social, demographic and quality of life variables will be collected from all participants.

Hypothesis:

The results of the research will have an impact on people with chronic anemia who would receive red blood cell transfusion when needed without delay. The improvement in the times of action would reduce decompensations from chronic diseases, visits to the emergency room and hospital admissions, and therefore would improve the quality of life of these patients. Furthermore, the management of the different interventions by the Case Management Nurse (EGC), in this regard, improves the current fragmentation of the different levels of care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• People over 40 years old

• Had received 2 or more red blood cell transfusions due to chronic disease, during a year.

• The health provider in Primary Care is the Institut Català de la Salut.

Exclusion Criteria:

• Presenting kidney failure on hemodialysis treatment.

• Being in palliative care situation

• Presenting a moderate-severe cognitive impairment, with a Pfeiffer scale score higher than 5.

• Not having a caregiver able to detect signs of decompensation.

Related Conditions & MeSH terms

• Anemia
• Red Blood Cell Transfusion

Intervention

Diagnostic Test:
• Monthly Haemoglobinometry
Monthly measurement of capillary hemoglobin with non-invasive techniques in primary health care. Inclusion in a transfusion circuit with referral to a hospital day hospital if necessary.

Locations

Country	Name	City	State
Spain	CAP La Llàntia	Mataró	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Number of hospital admissions	Anual mean of hospital admissions caused by haemoglobin concentration decline.	6 and 12 months.
Primary	Mean Number of visits to the emergency room	Anual mean of visits to the emergency room caused by haemoglobin concentration decline.	6 and 12 months.
Secondary	Quality of life self-assessment.	WHOQOL-BREF questionnaire.	6 and 12 months.
Secondary	Satisfaction with the intervention.	Ad-hoc questionnaire.	6 and 12 months.