Detection of Anemizations in Primary Care.

Study Overview
=================
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.

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

Conditions
-----------------
Anemia, Red Blood Cell Transfusion

Intervention / Treatment
-----------------
* Diagnostic Test: Monthly Haemoglobinometry


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monthly Haemoglobinometry<br> | Diagnostic Test: Monthly Haemoglobinometry<br>* 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.<br>|
| No Intervention: Routine monitoring<br> | |

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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Haemoglobinometry, Primary Care Nursing,, Advanced Practice Nursing