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Integrated Educational Session and Enhancing Compliance Behavior

Primary Purpose

Anemia, Iron-deficiency

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Integrated educational session
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anemia focused on measuring Iron deficiency, Moderate anemia, Compliance

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pregnant women
  • Primiparous
  • Singleton pregnancy
  • Literate

    *± 24 weeks gestation

  • Diagnosed moderate anemia
  • With normal BMI on booking (i.e. 24-25)

Exclusion Criteria:

  • 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

Sites / Locations

  • Rania Mahmoud Abdel Ghani

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Integrated Educational Session

Routine follow up

Arm Description

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.

Routine follow up

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Laboratory investigation for hemoglobin & ferrtin level
A sample of blood is tested in a lab. that helps to check the level of red blood cells (RBCs) and hemoglobin (Hb) concentration.
IRON Intake Calculation-Food Frequency Questionnaire (IRONIC-FFQ)
It was based on an iron food frequency assessment.All food products were categorized into twelve groups and thirty two related sub-groups characterized by a similar range of iron content. It consisted of open ended questions that specified the exact number of the individual consumption of iron food products during a typical week. To calculate the daily number of servings, the number of servings was divided by seven. The iron intake from the products was estimated by multiplying the daily number of servings by the typical iron content in one serving. A correlation coefficient was more than 0.85. Both in the assessment of validity and of reproducibility, a Bland-Altman index of 6.7% was recorded (93.3% of compared pairs of results were in the acceptable range, attributed to differences within ± 2 SD limit).
4) Dietary record diary (DRD).
It is self-record, an open-ended assessment method where the woman records all the foods and beverages consumed over a specific period of time thus minimizes reliance on memory

Full Information

First Posted
August 28, 2019
Last Updated
August 30, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04076969
Brief Title
Integrated Educational Session and Enhancing Compliance Behavior
Official Title
Effect of an Integrated Educational Session on Enhancing Compliance Behavior Among Pregnant Women With Iron Deficiency Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Data collection was conducted between April 2019 and December 2019.This study was grounded in the health compliance model(Heiby and Carlson, 1986) which proposed that elements of engagement between health care providers and patients involve activities that are likely to promote the development of information, produce productive emotions, and help develop the skills required to conduct health behavior. Such aspects of engagement include the healthcare provider listening to the patient's questions, engaging the patient in treatment decisions, and evaluating comprehension of the patient. For the first interview at 24 weeks' gestation, the pregnant women were re-informed about the purpose of the study and the schedule of follow-up. The baseline data that was gathered included test of the women's Hb levels during their routine antenatal visit, socio-demographic characteristics, and obstetric history. Three follow-up examinations were planned for pregnant women in both study and control groups at weeks 28, 32 and 36 of gestation. In the study group, pregnant women with anemia obtained an integrated health education in one session. The educational session was conducted by the principle investigator (PI) and was steered as 40-minutes session and provided individually to every participating woman. The content of the educational session included; disease specific knowledge, impact of anemia on maternal and neonatal outcomes, management opportunities, effectiveness, advantages and draw¬backs of treatment choices, iron-rich diet recognition, false eating patterns stopping iron absorption, and healthy diet. The PI has adopted the medical recommendations based on dietary guidelines for pregnancy(WHO, 2012). The pregnant women were given a chance to ask questions related to the session and its content. Furthermore, women were educated in recording all food and drink consumed inside and outside of the home, i.e. each meal/dish they got during the reporting duration of their diary, 24 hours of recall for seven days. They were also asked to report the exact portion size of the food by normal household measurements (e.g. plates, pots, cups, spoons, and glasses) or by kitchen scale. Additionally, each woman was advised to select the easiest way to remind her of her vitamin time. The pregnant women received an educational brochure at the end of the educational session which included all the information given in that session written in Arabic language. The literature-based educational brochure material was reviewed by three experts in the field of maternity nursing prior to the distribution. Each pregnant woman in both study and control groups was evaluated twice at 28 and 36 weeks' gestation for total dietary iron. The dietary iron intake recorded by women has been calculated using the IRONIC-FFQ and revised, when needed, by dietitian who was not involved in the study. In addition, the degree of the women's adherence to medication was measured by counting the total numbers of pills consumed between two scheduled appointments. For antenatal follow-up appointments for all women in the study and the control groups, phone calls were given monthly and women were reminded to record the iron intake diary seven days before their appointment. The participants returned their supplementary bottles with any unused capsules to the PI during their monthly visits to the antenatal clinic. Adherence to the supplementation scheme was determined based on the number of capsules left in the package after each return visit; adherence (percent)=[30-number of pills left in the package/number of days between the date of dispensation and the date of return]100. The equation was adopted based on the method used in(Cogswell et al., 2003). At the last data collection occasion at gestation week 36, the medication adherence scale was inserted along with check of Hb levels for all participating women. Pregnant women who were allocated to the control group received the routine antenatal care and follow-up, but no educational sessions or materials were provided to them Primary Outcome: Compliance degree Secondary Outcome: Iron food intake/mg, the hemoglobin level & ferritin levels

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron-deficiency
Keywords
Iron deficiency, Moderate anemia, Compliance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
there are two groups, the study group and the control group
Masking
Participant
Masking Description
The pregnant women were blinded to the intervention.
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrated Educational Session
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine follow up
Arm Type
Other
Arm Description
Routine follow up
Intervention Type
Behavioral
Intervention Name(s)
Integrated educational session
Intervention Description
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.
Primary Outcome Measure Information:
Title
The degree of the adherence to the medication
Description
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.
Time Frame
at 28 and 36 weeks gestation
Secondary Outcome Measure Information:
Title
Laboratory investigation for hemoglobin & ferrtin level
Description
A sample of blood is tested in a lab. that helps to check the level of red blood cells (RBCs) and hemoglobin (Hb) concentration.
Time Frame
at 24 and 36 weeks gestation
Title
IRON Intake Calculation-Food Frequency Questionnaire (IRONIC-FFQ)
Description
It was based on an iron food frequency assessment.All food products were categorized into twelve groups and thirty two related sub-groups characterized by a similar range of iron content. It consisted of open ended questions that specified the exact number of the individual consumption of iron food products during a typical week. To calculate the daily number of servings, the number of servings was divided by seven. The iron intake from the products was estimated by multiplying the daily number of servings by the typical iron content in one serving. A correlation coefficient was more than 0.85. Both in the assessment of validity and of reproducibility, a Bland-Altman index of 6.7% was recorded (93.3% of compared pairs of results were in the acceptable range, attributed to differences within ± 2 SD limit).
Time Frame
at 28 and 36 weeks gestation
Title
4) Dietary record diary (DRD).
Description
It is self-record, an open-ended assessment method where the woman records all the foods and beverages consumed over a specific period of time thus minimizes reliance on memory
Time Frame
at 28 and 36 weeks gestation

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant women Primiparous Singleton pregnancy Literate *± 24 weeks gestation Diagnosed moderate anemia With normal BMI on booking (i.e. 24-25) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rania Mahmoud A Ghani, PhD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rania Mahmoud Abdel Ghani
City
Faisal
State/Province
Giza
ZIP/Postal Code
002
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Rania MA. Effect of an Integrated Educational Session on Enhancing Compliance Behavior among Pregnant Women with Iron Deficiency Anemia. hptt//researchgate.com
Results Reference
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Integrated Educational Session and Enhancing Compliance Behavior

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