Effect of Health Information Package Program on Knowledge and Compliance Among Pregnant Women With Anemia
Primary Purpose
Knowledge, Anemia, Pregnant Women
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Health Information Package Program (HIP program )
Sponsored by
About this trial
This is an interventional other trial for Knowledge focused on measuring Health Information Package, anemia, pregnant women
Eligibility Criteria
inclusion criteria
- Aged between 18-45 years
- Hemoglobin level less than11 gm/dl and hematocrit less than 30%
- 14-20 pregnancy weeks
- Singleton fetus
- Have a smartphone with internet access (What's App) application
- Able to read and write
- Willing to give written informed consent to participate in the study.
Exclusion criteria:
- Cannot read and write,
- Have thalassemia or sickle cell anemia.
- Have a high-risk pregnancy.
- Had a history of psychiatric illness.
- Have already started iron supplementation for more than one week.
Sites / Locations
- Primary Health Care centers
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control group
Intervention group
Arm Description
Routine care only They will receive routine antenatal care that included iron supplementation with follow up of hemoglobin level
They will receive the Heath Information Package Program (HIP program)
Outcomes
Primary Outcome Measures
Haemoglobin
> 11 gm/ dl
Secondary Outcome Measures
knowledge
The overall number of knowledge related questions is 86 High knowledge: 57-71 Moderate knowledge: 36- 56 tablets Low knowledge: <36 tablets
compliance with iron supplementation
The overall number of iron tablets that should have been taken during the three month study period will be 90
High compliance: 68-90 tablets Moderate compliance: 45- 67 tablets Low compliance: <45 tablets
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04661865
Brief Title
Effect of Health Information Package Program on Knowledge and Compliance Among Pregnant Women With Anemia
Official Title
Effect of Health Information Package Program (HIP Program) on Knowledge, Compliance , and Hemoglobin Level Among Saudi Pregnant Women With Anemia: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jouf University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Problem description: low compliance with iron supplementation of Saudi pregnant women with anemia is a serious public health concern. The objectives of the study are to determine the effectiveness of the Health Information Package Program (HIP program) in Saudi anemic pregnant women on their compliance with iron supplementation, and level of hemoglobin. Methodology: Randomized Controlled Trial will be conducted on 196 Saudi anemic pregnant women attending the Maternity and Children Hospital in Saudi Arabia their gestational age between 14 and less than 20 weeks. All participants will receive iron supplementation and they will learn how to take tablets. They will randomly assign to two intervention and control groups (98 each) using a computer-generated table of random numbers.
The intervention group will receive a PowerPoint presentation of the Health Information Package Program (HIP program) that will be introduced by the principal investigator, combined with PowerPoint slides to educate women about anemia in pregnancy and send it to them via Whatsapp application while the control group will receive usual care. The participants will be informed about the nature and aim of the study with assuring confidentiality and anonymity. Expected outcome: Health Information Package Program (HIP program) will be effective in terms of increasing women's knowledge regarding anemia during pregnancy, increase compliance with iron supplementation, and hemoglobin level.
Detailed Description
The present study aims to assess the efficacy of the Health information package program (HIP program) on compliance with iron supplementation pills, and the level of hemoglobin among Saudi pregnant women with anemia.
The study will be conducted in antenatal outpatient clinics at primary health care centers.
Data Collection tools
I- Demographic and health-related information included data related to women's age, marriage age, level of education, gestational age, parity, body mass index, inter-pregnancy interval, history of excessive or abnormal bleeding during menstruation, and level of hemoglobin.
II- compliance with iron supplementation included questions related to the extent of compliance with iron supplementation among anemic pregnant women and the reason for compliance or non-compliance.
III- The food selection ability checklist contained food items that are rich and poor sources of iron, vitamin C, and protein.
IV- Structured Knowledge Interview Schedule (SKIS): This tool was developed to assess women information before and after the intervention, it contained questions regarding the concept of pregnancy, anemia in pregnancy, causes of iron deficiency anemia, signs and symptoms, the effect of anemia on pregnancy, prevention, and management of iron deficiency anemia. Each correct answer is assigned one point. The maximum number of total possible points was 86.
Random assignment will use to classify the participants equally (98 women each) either in the intervention or control groups using a computer-generated table of random numbers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knowledge, Anemia, Pregnant Women
Keywords
Health Information Package, anemia, pregnant women
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group A: intervention group who will receive iron supplementation and Heath Information Package Program (HIP program) Group B: Control group: will receive iron supplementation and routine care
Masking
ParticipantOutcomes Assessor
Masking Description
The researchers will interview participants, explain the purpose of the study and they will ask them to sign the consent. All participants will receive iron supplementation and they will learn how to take tablets.
They will randomly assign in two intervention and control groups (98 each) using a computer-generated table of random numbers and they are unaware of which group they have been assigned to as well as the outcome assessor is unaware
Allocation
Randomized
Enrollment
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Other
Arm Description
Routine care only They will receive routine antenatal care that included iron supplementation with follow up of hemoglobin level
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
They will receive the Heath Information Package Program (HIP program)
Intervention Type
Other
Intervention Name(s)
Health Information Package Program (HIP program )
Intervention Description
Fifteen minutes PowerPoint presentation will be introduced to women to increase women's educational experience and raise their level of engagement and commitment.
The principal investigator will narrate the video record with PowerPoint slides and it was recorded as a video and will include information regarding the introduction to pregnancy, causes and predisposing factors of iron deficiency anemia during pregnancy, signs and symptoms, prevention, management of iron deficiency anemia during pregnancy that includes iron therapy, iron supplementation, dietary management. Content validity for the information in the video will be done by sending it to three experts in maternity nursing. Iron supplementation will be given to all participants who will start by sixteen weeks of pregnancy and they will receive information regarding the proper usage of iron supplements.
Primary Outcome Measure Information:
Title
Haemoglobin
Description
> 11 gm/ dl
Time Frame
after three months ( 90 days ± 7 days)
Secondary Outcome Measure Information:
Title
knowledge
Description
The overall number of knowledge related questions is 86 High knowledge: 57-71 Moderate knowledge: 36- 56 tablets Low knowledge: <36 tablets
Time Frame
after three months ( 90 days ± 7 days) - study period
Title
compliance with iron supplementation
Description
The overall number of iron tablets that should have been taken during the three month study period will be 90
High compliance: 68-90 tablets Moderate compliance: 45- 67 tablets Low compliance: <45 tablets
Time Frame
after three months ( 90 days ± 7 days)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Aged between 18-45 years
14-20 pregnancy weeks
pregnant in singleton fetus
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
inclusion criteria
Aged between 18-45 years
Hemoglobin level less than11 gm/dl and hematocrit less than 30%
14-20 pregnancy weeks
Singleton fetus
Have a smartphone with internet access (What's App) application
Able to read and write
Willing to give written informed consent to participate in the study.
Exclusion criteria:
Cannot read and write,
Have thalassemia or sickle cell anemia.
Have a high-risk pregnancy.
Had a history of psychiatric illness.
Have already started iron supplementation for more than one week.
Facility Information:
Facility Name
Primary Health Care centers
City
Jouf- Saudi Arabia
State/Province
Jouf
ZIP/Postal Code
3677
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No personal identification data will be collected, so the researchers assure participants' anonymity.
The researchers will collect only the data required to this study.
Demographic data of participants will be coded to maintain confidentiality.
All submitted data are saved and handled electronically by the researchers only through password-protected files.
Learn more about this trial
Effect of Health Information Package Program on Knowledge and Compliance Among Pregnant Women With Anemia
We'll reach out to this number within 24 hrs