Effect of Empowerment-Based Interventions on Self-Efficacy and Self-Care Capacity Among Adults With Sickle Cell Disease

February 28, 2024 updated by: Zohour Ibrahim Mahmoud Rashwan, University of Bahrain

This study aimed to To investigate the effect of empowerment-based interventions (EBI) on self-efficacy and self-care capacity among adults with Sickle Cell Disease (SCD).

The hypotheses of this study were: Adults with SCD who receive EBI exhibit higher self-efficacy, self- management capacity and HRQoL than those who do not.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A pre-test-post-test control group experimental study was conducted at two randomly selected health centers in Bahrain using a cluster sampling technique. A sample of 68 out of 122 adults with SCD was randomly assigned to two groups. The EBI was implemented through structured small-group discussion sessions, individualized consultations, and follow-up sessions. Individualized consultations for self-management were done by adopting the 5A model (assess, advise, agree, assist, and arrange). Weekly communication was done to check the patient's progress, and both groups were re-evaluated for self-efficacy and self-care capacity after one month.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bahrain
      • Manama, Bahrain, 11511
        • College of Health and Sport Sciences, University of Bahrain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult patients with SCD f
  • Receiving treatment from primary health care facilities
  • Able to read and write
  • Having the chance to attend the educational sessions .

Exclusion Criteria:

  • A history of mental illness .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Empowerment-Based Interventions (EBI)
The EBI was used for the study group. It is an integrative educational program under the patient-centered care approach emphasizing collaborative patient interaction. The EBI was implemented through structured (a) small-group discussion sessions, (b) individualized consultations, and (c) follow-up sessions.
Behavioral: Empowerment-Based Interventions
The Empowerment-Based Interventions was used for the study group. It is an integrative educational program under the patient-centered care approach emphasizing collaborative patient interaction. The EBI was implemented through structured (a) small-group d
Active Comparator: standard health education
Patients in the control group received standard health education from SCD clinics in the HC. The clinic employs a multidisciplinary team, including a nurse, a physician, a health record clerk, a laboratory technician, a social worker, and a health promotion specialist, to provide integrated patient health services. It consists of both preventative and curative services. The nurses at the health center provide patients with information regarding factors that may cause vaso-occlusion and precipitate VOCs when to seek emergency care and educate patients on the significance of regular medical examinations and screening using different standardized audiovisual aids.
Behavioral: Standard Health Education
Patients in the control group received standard health education from SCD clinics in the HC. The clinic employs a multidisciplinary team, including a nurse, a physician, a health record clerk, a laboratory technician, a social worker, and a health promotion specialist, to provide integrated patient health services. It consists of both preventative and curative services. The nurses at the health center provide patients with information regarding factors that may cause vaso-occlusion and precipitate VOCs when to seek emergency care and educate patients on the significance of regular medical examinations and screening using different standardized audiovisual aids.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sickle Cell Self-Efficacy
Time Frame: 1 month
This scale was designed by Edwards et al. (2000) to assess the self-appraisals of adult patients with sickle cell disease for their ability to engage in daily functional activities(22). It is composed of nine items rated on a five-point Likert scale ranging from "not at all sure" to "very sure cell disease for their ability to engage in daily functional activities. It is composed of nine items rated on a five-point Likert scale ranging from "not at all sure" to "very sure." The total score ranged from 9 to 45, with higher scores indicating higher levels of self-efficacy.
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-Care Capacity
Time Frame: 1 month
This scale was originally developed by Kearney and Fleischer (1979) according to Orem's self-care theory and revised by Wang and Laffrey (2000) to assess the level of health-related self-care capacity(24,25). The scale consists of 15 items, rated on a 5-point Likert scale ranging from "totally disagree" (1 point) to "totally agree" (5 points).
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bahrain

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: adnan Bekhit, Professor, College of Health and Sport Sciences, University of Bahrain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 21, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25/2021-22 dt. Dec. 12,2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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