Educational Intervention Among Informal Caregivers of Person With Dementia

NCT06003647 | Unknown

• 1 other identifier: NMRR-19-3298-50711
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this intervention study is to test whether the educational intervention work well or not on informal caregiver of person with dementia. The main question it aims to answer is does the educational intervention will help to reduce the caregiver burden experience by the informal caregiver. Participants will be given an educational module and short videos that they can refer to gain more knowledge and skills in caring for the person with dementia.

Conditions

Caregiver Burden

Keywords

Informal caregiver of person with dementia; Educational intervention

Outcome Measures

Primary Outcomes (1)

• Caregiver Burden

  The caregiver burden measured by using Zarit Burden Interview (ZBI). ZBI consisted of 22 items with all negative statements. The scoring will be zero for never, one for rarely, two for sometimes, three for quite frequently and four for nearly always. The scoring can be from zero to 88 with scoring of 0 to 21 little or no burden, 21 to 40 mild to moderate burden, 41 to 60 moderates to severe burden, and 61 to 88 severe burdens.

  Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention

Secondary Outcomes (6)

• Socio-demographic characteristic

  Baseline

• Caregiving characteristics

  Baseline

• Caregiver knowledge on dementia

  Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention

• Caregiver self-esteem

  Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention

• Caregiver mastery

  Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention

Study Arms (2)

Control

NO INTERVENTION

Receive normal care

Intervention

EXPERIMENTAL

Educational intervention

Other: Educational Intervention

Interventions

Educational Intervention OTHER

Educational module and video

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informal caregiver of person with dementia (children, children in law, grandchildren, grandchildren in law, spouses, siblings, parents).
• Age 18 years old and above.
• Able to understand, read and speak Bahasa Malaysia language

You may not qualify if:

• Caregiver with previous history of mental illness.
• Caregiver with physical disabilities that cause limitation in providing care for person with dementia.
• Paid informal caregiver (maid).

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

MeSH Terms

Conditions

Caregiver Burden

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Nuraisyah Hani Zulkifley

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ms

CONTACT

+60195249479; hanizulkifley@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 22, 2023
• Study Start: December 15, 2023
• Primary Completion: March 31, 2024
• Study Completion: September 1, 2024
• Last Updated: November 29, 2023

Record last verified: 2023-11