Detection of Anemizations in Primary Care.

Not Applicable

• Conditions: Anemia; Red Blood Cell Transfusion
• Interventions: Diagnostic Test: Monthly Haemoglobinometry

• Registration Number: NCT04757909
• Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-30
• Status Verified: 2021-02
• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-16
• Last Update Submitted: 2021-02-16
• Study First Posted: 2021-02-17
• Last Update Posted: 2021-02-17
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monthly Haemoglobinometry	Monthly Haemoglobinometry	-

Primary Outcome Measures

Name	Time	Method
Mean Number of hospital admissions	6 and 12 months.	Anual mean of hospital admissions caused by haemoglobin concentration decline.
Mean Number of visits to the emergency room	6 and 12 months.	Anual mean of visits to the emergency room caused by haemoglobin concentration decline.

Secondary Outcome Measures

Name	Time	Method
Quality of life self-assessment.	6 and 12 months.	WHOQOL-BREF questionnaire.
Satisfaction with the intervention.	6 and 12 months.	Ad-hoc questionnaire.

Trial Locations

Locations (1)

CAP La Llàntia; 🇪🇸 Mataró, Barcelona, Spain