NCT06682338

Brief Summary

The study focused on Sudanese people with diabetes who experienced the ongoing war in Sudan. Some people were displaced and others were not. This would had an impact on their mental health. We have investigated this impact and any complications happened to them through Self-Administered questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

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

April 21, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

November 7, 2024

Last Update Submit

November 7, 2024

Conditions

Psychological Impact of Armed ConflictDiabetes Complications

Keywords

DASS-21SudanPsychologicalArmed conflictDiabetics

Outcome Measures

Primary Outcomes (1)

  • Psychological Impact

    Measured by Depression Anxiety Stress Scale-21 questionnaire.

    April 2024 - July 2024

Secondary Outcomes (1)

  • Diabetes complications

    April 2024 - July 2024

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Sudanese Diabetic Patients above 18 years old, of both genders, from Khartoum and Gezira states.

You may not qualify if:

  • Non Diabetic, pre-existing psychological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research and Publication Office, Dental Alumni and Students Affairs, Karary University

Omdurman, Khartoum State, Sudan

Location

MeSH Terms

Conditions

Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes MellitusEndocrine System Diseases

Study Officials

  • Alaa MAK Alshykh, BDS

    Research and Publication Office, Dental Alumni and Students Affairs, Karary University

    STUDY CHAIR

  • Mai AA Balal, BDS

    Research and Publication Office, Dental Alumni and Students Affairs, Karary University

    STUDY CHAIR

  • Mohamed HA Nasr, PhD

    International University of Africa / Omdurman Ahlia University

    STUDY DIRECTOR

  • Afaf MH Jabir, BDS

    Federal Ministry of Health, Sudan

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Leader of Public Health Group

Study Record Dates

First Submitted

November 7, 2024

First Posted

November 12, 2024

Study Start

April 21, 2024

Primary Completion

July 20, 2024

Study Completion

August 20, 2024

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

SU(1)