Detection of Anemizations in Primary Care. (ANHEMOG)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anemia; Red Blood Cell Transfusion
• Intervention / Treatment: Diagnostic test: Monthly Haemoglobinometry

• Study Type: Interventional
• Enrollment (Anticipated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Boris Trenado Luengo, RN; Phone Number: 0034 93384 24 25; Email: btrenado.mn.ics@gencat.cat
• Study Contact Backup: Name: Pere Toran-Montserrat, MD; Phone Number: 003493 741 53 38; Email: ptoran.bnm.ics@gencat.cat

Study Locations

• Spain
  • Barcelona
    • Mataró, Barcelona, Spain, 08303
      • Recruiting
      • CAP La Llàntia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monthly Haemoglobinometry	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.
No Intervention: Routine monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Number of hospital admissions	Anual mean of hospital admissions caused by haemoglobin concentration decline.	6 and 12 months.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life self-assessment.	WHOQOL-BREF questionnaire.	6 and 12 months.
Satisfaction with the intervention.	Ad-hoc questionnaire.	6 and 12 months.

Collaborators and Investigators

• Sponsor: Jordi Gol i Gurina Foundation

Publications and helpful links

General Publications

• Luengo BT, García-Sierra R, Trinxant MAW, Mondelo ED, Baseda RM, Blanch MML, Del Pilar Montero Alia M, Toran-Monserrat P. Early detection of anaemia in primary care with haemoglobinometry: ANHEMOG clinical trial protocol. BMC Fam Pract. 2021 Oct 8;22(1):199. doi: 10.1186/s12875-021-01548-z.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2017
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Haemoglobinometry; Primary Care Nursing,; Advanced Practice Nursing
• Other Study ID Numbers: 4R17/013 (Other Grant/Funding Number: Direcció Atenció Primària Metropolitana Nord); 4R18/08 (Other Grant/Funding Number: Academia de Ciencias Médicas filial de Maresme)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Study protocol will be sent to publication in the next months
• IPD Sharing Time Frame: Open access to read as soon as published
• IPD Sharing Access Criteria: Open
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No