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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06296654
Other study ID # 25/2021-22 dt. Dec. 12,2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 20, 2022
Est. completion date October 22, 2022

Study information

Verified date February 2024
Source University of Bahrain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 do not.


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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date October 22, 2022
Est. primary completion date October 21, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
Bahrain College of Health and Sport Sciences, University of Bahrain Manama

Sponsors (1)

Lead Sponsor Collaborator
University of Bahrain

Country where clinical trial is conducted

Bahrain, 

References & Publications (4)

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. — View Citation

Castro 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. — View Citation

Cheng 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. — View Citation

Crosby 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 month
Secondary 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). 1 month
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