Integrated Educational Session and Enhancing Compliance Behavior

NCT04076969 | Completed DMC

• 1 other identifier: 00004025
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to determine the effect of an integrated educational session on enhancing compliance behavior among pregnant women with iron deficiency anemia.The anemic pregnant women in the study group received an integrated health education in one session. While pregnant women who were allocated to the control group received the routine antenatal care and follow up.

Conditions

Anemia; Iron-deficiency

Keywords

Iron deficiency; Moderate anemia; Compliance

Outcome Measures

Primary Outcomes (1)

• The degree of the adherence to the medication

  Counting the total numbers of pills have been received (i.e. The numbers of dosage units (pills) that have been taken between two scheduled appointments were counted). Adherence to the supplementation regimen was calculated on the basis of the number of capsules remaining in the package at each return visit; adherence (%)=\[30-number of pills left in the package/number of days between dispensing date and return date\] ×100.

  at 28 and 36 weeks gestation

Secondary Outcomes (3)

• Laboratory investigation for hemoglobin & ferrtin level

  at 24 and 36 weeks gestation

• IRON Intake Calculation-Food Frequency Questionnaire (IRONIC-FFQ)

  at 28 and 36 weeks gestation

• 4) Dietary record diary (DRD).

  at 28 and 36 weeks gestation

Study Arms (2)

Integrated Educational Session

EXPERIMENTAL

The anemic pregnant women in the study group received an integrated health education in one session. The educational session was steered as 40-minutes session in a personalized manner. The educational session content included; disease specific information, effect of anemia on maternal and neonatal outcome, management possibilities, the effectiveness, benefits and disadvantages of treatment options, identify diet rich with iron, false dietary habits prevent iron absorption and the balanced diet and meals.

Behavioral: Integrated educational session

Routine follow up

OTHER

Routine follow up

Behavioral: Integrated educational session

Interventions

Integrated educational session BEHAVIORAL

The educational session aimed to correct the pregnant women diatery habits and enhance the degree of compliance to the iron treatment and follow up instruction.

Integrated Educational Session; Routine follow up

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women
• Primiparous
• Singleton pregnancy
• Literate
• \*± 24 weeks gestation
• Diagnosed moderate anemia
• With normal BMI on booking (i.e. 24-25)

You may not qualify if:

• Pregnant women who had history of blood transfusion (within the previous 2 weeks)
• Had any medical diseases
• Had risk pregnancy including bleeding disorders with multiple gestation Those who refused to consent

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Rania Mahmoud Abdel Ghani

Faisal, Giza Governorate, 002, Egypt

Location

Related Publications (1)

• Rania MA. Effect of an Integrated Educational Session on Enhancing Compliance Behavior among Pregnant Women with Iron Deficiency Anemia. hptt//researchgate.com

  BACKGROUND

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Patient Compliance

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Rania Mahmoud A Ghani, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The pregnant women were blinded to the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant professor

Model Details: there are two groups, the study group and the control group

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 4, 2019
• Study Start: January 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)