NCT06296654

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
Last Updated

March 6, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

February 28, 2024

Last Update Submit

February 28, 2024

Conditions

Keywords

Sickle Cell DiseaseSelf-efficacySelf-ManagementActivities of Daily Living

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Self-Care Capacity

    1 month

Study Arms (2)

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.

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.

Behavioral: Standard Health Education

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

Empowerment-Based Interventions (EBI)

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.

standard health education

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 .

You may not qualify if:

  • A history of mental illness .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Health and Sport Sciences, University of Bahrain

Manama, 11511, Bahrain

Location

Related 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.

    PMID: 34555941BACKGROUND
  • 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.

    PMID: 27450481BACKGROUND
  • 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.

    PMID: 31679744BACKGROUND
  • 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.

    PMID: 32697889BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • adnan Bekhit, Professor

    College of Health and Sport Sciences, University of Bahrain

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 28, 2024

First Posted

March 6, 2024

Study Start

March 20, 2022

Primary Completion

October 21, 2022

Study Completion

October 22, 2022

Last Updated

March 6, 2024

Record last verified: 2024-02

Locations