NCT04757909

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2017

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

5.7 years

First QC Date

February 15, 2021

Last Update Submit

February 16, 2021

Conditions

AnemiaRed Blood Cell Transfusion

Keywords

HaemoglobinometryPrimary Care Nursing,Advanced Practice Nursing

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Quality of life self-assessment.

    6 and 12 months.

  • Satisfaction with the intervention.

    6 and 12 months.

Study Arms (2)

Monthly Haemoglobinometry

EXPERIMENTAL
Diagnostic Test: Monthly Haemoglobinometry

Routine monitoring

NO INTERVENTION

Interventions

Monthly HaemoglobinometryDIAGNOSTIC_TEST

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.

Monthly Haemoglobinometry

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAP La Llàntia

Mataró, Barcelona, 08303, Spain

RECRUITING

Related Publications (2)

  • Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.

    PMID: 38780066DERIVED

  • Luengo BT, Garcia-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.

    PMID: 34625027DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Boris Trenado Luengo, RN

CONTACT

0034 93384 24 25btrenado.mn.ics@gencat.cat

Pere Toran-Montserrat, MD

CONTACT

003493 741 53 38ptoran.bnm.ics@gencat.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2021

First Posted

February 17, 2021

Study Start

March 30, 2017

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

February 17, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

Study protocol will be sent to publication in the next months

Shared Documents
STUDY PROTOCOL
Time Frame
Open access to read as soon as published
Access Criteria
Open

Locations

ES(1)