NCT05572086

Brief Summary

Dementia is a widespread incapacitating mental syndrome that carries a significant challenge for healthcare systems, persons with dementia, and their caregivers. The world health organization estimates that there is "more than 55 million persons live with dementia worldwide, and there are nearly 10 million new cases every year" In Egypt there are many studies had investigated caregiver burden with chronic ill elderly as physical or psychiatric diseases; however, studies focusing on caregiving Patients With Dementia (PWD), especially the psychological aspect, has been raised just few years ago. Some focused on psychiatric comorbidities of care givers, others correlated caregivers' quality of life with dementia staging. Other research groups designed educational programs and psychosocial interventions for training informal caregivers with significant psychological burden reduction at the end of the studies , also another group focused their study on the negative emotions expressed by caregiver towards PWD. Still there are many aspects of caregiving not explored considering the financial burden, lack of formal educational resources, stigma, cultural and religious values related to caregiving.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
314

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

September 30, 2022

Last Update Submit

October 5, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of caregiver burden

    By using Zarit Burden Interview

    one year

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

caregivers of patients with dementia from community or from patients coming to hospital for medical issues related to dementia with interview with their caregiver through face-to-face, on line, or telephone interview

You may qualify if:

  • Informal Caregivers aged 18 years or older
  • Informal Caregiver in daily contact for care with the person with dementia for at least one year.

You may not qualify if:

  • Informal caregivers who are unable or unwilling to communicate.
  • Formal caregivers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

September 30, 2022

First Posted

October 7, 2022

Study Start

February 1, 2023

Primary Completion

February 1, 2024

Study Completion

June 1, 2024

Last Updated

October 7, 2022

Record last verified: 2022-10