AnemiaNCT04076969
Integrated Educational Session and Enhancing Compliance Behavior
A study testing Integrated educational session in people with Anemia and Iron-deficiency, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Anemia, Iron-deficiency
- What is being tested?
- Integrated educational session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women
- Primiparous
- Singleton pregnancy
- Literate
- ± 24 weeks gestation
- Diagnosed moderate anemia
- With normal BMI on booking (i.e. 24-25)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of an Integrated Educational Session on Enhancing Compliance Behavior Among Pregnant Women With Iron Deficiency Anemia
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.
Read the 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
- Conditions
- Anemia, Iron-deficiency
- Being tested
- Integrated educational session
- Keywords
- Iron deficiency, Moderate anemia, Compliance
- Medical subject headings
- Anemia, Anemia, Iron-Deficiency, Iron Deficiencies, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated educational sessionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Integrated educational session |
| Routine follow up | Other | Routine follow up Receives: Behavioral: Integrated educational session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 28 and 36 weeks gestation
Secondary outcomes (3)
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.
Measured: at 24 and 36 weeks gestation
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).
Measured: at 28 and 36 weeks gestation
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
Measured: at 28 and 36 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start1 Jan 2019
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- there are two groups, the study group and the control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Mahmoud Abdel Ghani, Cairo University
- Investigators
- Rania Mahmoud A Ghani, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076969
- Sponsor's protocol ID
- 00004025
- Status last verified
- Aug 2020
- First submitted
- 28 Aug 2019
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rania MA. Effect of an Integrated Educational Session on Enhancing Compliance Behavior among Pregnant Women with Iron Deficiency Anemia. hptt//researchgate.com
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Integrated Educational Session on Enhancing Compliance Behavior Among Pregnant Women With Iron Deficiency Anemia
- ClinicalTrials.gov ID
- NCT04076969
- Acronym / sponsor ID
- 00004025
- Conditions
- Anemia, Iron-deficiency
- Keywords
- Iron deficiency, Moderate anemia, Compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- there are two groups, the study group and the control group
| Arm | Type | Receives |
|---|---|---|
| Integrated Educational Session | Experimental | Behavioral: Integrated educational sessionThe 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 | Other | Behavioral: Integrated educational sessionRoutine follow up |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pregnant women
- Primiparous
- Singleton pregnancy
- Literate
- ± 24 weeks gestation
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated educational sessionThe educational session aimed to correct the pregnant women diatery habits and enhance the degree of compliance to the iron treatment and follow up instruction. | Behavioural | Integrated Educational Session, Routine follow up |
Primary outcome
The degree of the adherence to the medication
Time frame: at 28 and 36 weeks gestation
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.
3 secondary outcomes
Laboratory investigation for hemoglobin & ferrtin level
Time frame: at 24 and 36 weeks gestation
IRON Intake Calculation-Food Frequency Questionnaire (IRONIC-FFQ)
Time frame: at 28 and 36 weeks gestation
4) Dietary record diary (DRD).
Time frame: at 28 and 36 weeks gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- BackgroundRania MA. Effect of an Integrated Educational Session on Enhancing Compliance Behavior among Pregnant Women with Iron Deficiency Anemia. hptt//researchgate.com
- Individual participant dataSharing planned: No
Related trials for Anemia
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
RecruitingObservational study
A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapsed or Refractory
Active, not recruitingPhase 3
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Atypical Hemolytic Uremic Syndrome
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rania Mahmoud A Ghani, PhD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated educational session in people with Anemia and Iron-deficiency, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of the adherence to the medication (time frame: at 28 and 36 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04076969, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.