ClinicalTrials.gg
CompletedNCT06296654Updated Mar 6, 2024

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

An interventional study of Empowerment-Based Interventions and Standard Health Education in Self-Efficacy and Self-Care, sponsored by University of Bahrain. Completed at 1 site in Bahrain. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-06.

Sponsored by University of Bahrain · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Mar 2022, registered Feb 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Self-Efficacy
  • Self-Care

Browse trials for

Keywords

  • Sickle Cell Disease
  • Self-efficacy
  • Self-Management
  • Activities of Daily Living
03

In context

Anemia, Sickle Cell

1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.

This study's enrollment of 68 is above the median of 40 across 769 interventional studies indexed under Anemia, Sickle Cell.

Browse Anemia, Sickle Cell studies →

Lead sponsor

University of Bahrain is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • A history of mental illness .
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
68 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralEmpowerment-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

  • BehavioralStandard 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.

06

What researchers measure

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.

    Time frame: 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).

    Time frame: 1 month

07

Study locations

1 site
  • College of Health and Sport Sciences, University of Bahrain
    Manama, 11511, Bahrain
08

References and documents

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 34555941 ↗
  • 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. PubMed 27450481 ↗
  • 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. PubMed 31679744 ↗
  • 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. PubMed 32697889 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2022 to primary completion in Oct 2022, 7 months.

Of 165 non-industry interventional studies with no phase under Anemia, Sickle Cell, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 54. This study's 7 months is below that.

Counting every sponsor, half of 173 studies reached it within 28 months; a quarter within 15 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2024
First posted
Mar 6, 2024
StartActual
Mar 20, 2022
Primary completionActual
Oct 21, 2022
CompletionActual
Oct 22, 2022
Last update
Mar 6, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06296654
Lead sponsor
University of Bahrain
Responsible party
Zohour Ibrahim Mahmoud Rashwan (Assistant Professor, University of Bahrain) — Principal investigator
First posted
Mar 6, 2024
Start date
Mar 20, 2022
Primary completion
Oct 21, 2022
Completion
Oct 22, 2022
Last update
Mar 6, 2024

Study contacts

adnan Bekhit, Professor
study chair · College of Health and Sport Sciences, University of Bahrain

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion