Self-EfficacyNCT06296654
Effect of Empowerment-Based Interventions on Self-Efficacy and Self-Care Capacity Among Adults With Sickle Cell Disease
A study testing Empowerment-Based Interventions and Standard Health Education in people with Self-Efficacy and Self-Care, run by University of Bahrain at 1 site in Bahrain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Self-Efficacy, Self-Care
- What is being tested?
- Empowerment-Based Interventions and Standard Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteBahrain
- Study dates
- 20 Mar 2022to 22 Oct 2022
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 .
Who cannot join
- A history of mental illness .
Trial locations and contacts
1 site in 1 country.
Bahrain1 site
College of Health and Sport Sciences, University of Bahrain
Manama, 11511
About this study
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.
Read the 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.
- Conditions
- Self-Efficacy, Self-Care
- Being tested
- Empowerment-Based Interventions, Standard Health Education
- Keywords
- Sickle Cell Disease, Self-efficacy, Self-Management, Activities of Daily Living
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowerment-Based InterventionsBehavioural
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
Standard Health EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Empowerment-Based Interventions (EBI) | Experimental | 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. Receives: Behavioral: Empowerment-Based Interventions |
| standard health education | Active comparator | 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. Receives: Behavioral: Standard Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sickle Cell Self-Efficacy
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.
Measured: 1 month
Secondary outcomes (1)
Self-Care Capacity
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).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start20 Mar 2022
- Primary completion21 Oct 2022
- Study completion22 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Self-EfficacyStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bahrain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zohour Ibrahim Mahmoud Rashwan, University of Bahrain
- Investigators
- adnan Bekhit, Professor, Study chair, College of Health and Sport Sciences, University of Bahrain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296654
- Sponsor's protocol ID
- 25/2021-22 dt. Dec. 12,2021
- Status last verified
- Feb 2024
- First submitted
- 28 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Al Raqaishi H, Al Qadire M, Alzaabi O, Al Omari O. Health-Related Stigma, Social Support, Self-Efficacy, and Self-Care Actions Among Adults With Sickle Cell Disease in Oman. Clin Nurs Res. 2022 Jun;31(5):803-811. doi: 10.1177/10547738211046731. Epub 2021 Sep 24.
PubMed 34555941Castro EM, Van Regenmortel T, Vanhaecht K, Sermeus W, Van Hecke A. Patient empowerment, patient participation and patient-centeredness in hospital care: A concept analysis based on a literature review. Patient Educ Couns. 2016 Dec;99(12):1923-1939. doi: 10.1016/j.pec.2016.07.026. Epub 2016 Jul 18.
PubMed 27450481Cheng L, Sit JWH, Choi KC, Chair SY, Li X, Wu Y, Long J, Yang H. The effects of an empowerment-based self-management intervention on empowerment level, psychological distress, and quality of life in patients with poorly controlled type 2 diabetes: A randomized controlled trial. Int J Nurs Stud. 2021 Apr;116:103407. doi: 10.1016/j.ijnurstu.2019.103407. Epub 2019 Sep 5.
PubMed 31679744Crosby LE, Hood A, Kidwell K, Nwankwo C, Peugh J, Strong H, Quinn C, Britto MT. Improving self-management in adolescents with sickle cell disease. Pediatr Blood Cancer. 2020 Oct;67(10):e28492. doi: 10.1002/pbc.28492. Epub 2020 Jul 22.
PubMed 32697889
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Empowerment-Based Interventions on Self-Efficacy and Self-Care Capacity Among Adults With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT06296654
- Acronym / sponsor ID
- 25/2021-22 dt. Dec. 12,2021
- Conditions
- Self-Efficacy, Self-Care
- Keywords
- Sickle Cell Disease, Self-efficacy, Self-Management, Activities of Daily Living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of BahrainUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 22 Oct 2022 (actual)
- First posted
- 6 Mar 2024 (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 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empowerment-Based Interventions (EBI) | Experimental | Behavioral: Empowerment-Based InterventionsThe 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. |
| standard health education | Active comparator | Behavioral: Standard Health EducationPatients 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 .
Key exclusion criteria (1 listed)
- A history of mental illness .
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 |
|---|---|---|
| Empowerment-Based InterventionsThe 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 | Behavioural | Empowerment-Based Interventions (EBI) |
| Standard Health EducationPatients 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. | Behavioural | standard health education |
Primary outcome
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 secondary outcome
Self-Care Capacity
Time frame: 1 month
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 6 Mar 2024.
- Background: PubMed 34555941Al Raqaishi H, Al Qadire M, Alzaabi O, Al Omari O. Health-Related Stigma, Social Support, Self-Efficacy, and Self-Care Actions Among Adults With Sickle Cell Disease in Oman. Clin Nurs Res. 2022 Jun;31(5):803-811. doi: 10.1177/10547738211046731. Epub 2021 Sep 24.
- Background: PubMed 27450481Castro EM, Van Regenmortel T, Vanhaecht K, Sermeus W, Van Hecke A. Patient empowerment, patient participation and patient-centeredness in hospital care: A concept analysis based on a literature review. Patient Educ Couns. 2016 Dec;99(12):1923-1939. doi: 10.1016/j.pec.2016.07.026. Epub 2016 Jul 18.
- Background: PubMed 31679744Cheng L, Sit JWH, Choi KC, Chair SY, Li X, Wu Y, Long J, Yang H. The effects of an empowerment-based self-management intervention on empowerment level, psychological distress, and quality of life in patients with poorly controlled type 2 diabetes: A randomized controlled trial. Int J Nurs Stud. 2021 Apr;116:103407. doi: 10.1016/j.ijnurstu.2019.103407. Epub 2019 Sep 5.
- Background: PubMed 32697889Crosby LE, Hood A, Kidwell K, Nwankwo C, Peugh J, Strong H, Quinn C, Britto MT. Improving self-management in adolescents with sickle cell disease. Pediatr Blood Cancer. 2020 Oct;67(10):e28492. doi: 10.1002/pbc.28492. Epub 2020 Jul 22.
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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.
adnan Bekhit, Professor study chair
College of Health and Sport Sciences, University of Bahrain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowerment-Based Interventions and Standard Health Education in people with Self-Efficacy and Self-Care, run by University of Bahrain at 1 site in Bahrain.
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 4 inclusion and 1 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 6 Mar 2024. 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 Bahrain. 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?
Sickle Cell Self-Efficacy (time frame: 1 month). 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 NCT06296654, which also lists 4 linked publications.
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 6 Mar 2024.