NCT05990114

Brief Summary

The aim of this clinical study is to examine the effect of an intervention program developed for informal caregivers of Alzheimer's patients on caregivers' burden of care, psychological well-being and psychological resilience.The main questions it aims to answer are:

  1. 1.What is the effect of the Structured Caregiver Support Program (SCSP) on caregivers burden?
  2. 2.What is the effect of the SCSP on psychological well-being?
  3. 3.What is the effect of the SCSP on psychological resilience?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable alzheimer-disease

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 4, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2023

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

August 3, 2023

Last Update Submit

March 28, 2025

Conditions

Keywords

psychosocial interventionAlzheimer's diseasecaregiverscare burdenpsychological well-beingpsychological resilience

Outcome Measures

Primary Outcomes (1)

  • Zarit Burden Interview

    This scale, which was developed by Zarit, Reever and Bach-Peterson in 1980, is used to measure the stress of caregivers.A minimum of 0 and a maximum of 88 points can be obtained from the scale. A high score on the scale indicates a high level of distress.

    change from baseline to the end of the 8th week

Secondary Outcomes (2)

  • Psychological Well-Being Scale

    change from baseline to the end of the 8th week

  • Brief Resilience Scale

    change from baseline to the end of the 8th week

Study Arms (2)

intervention group

EXPERIMENTAL

The structured caregiver support program is a psychosocial training program developed to improve caregivers' burden of care, psychological well-being and resilience.This training program will be applied to the intervention group.

Other: The structured caregiver support program

control group

NO INTERVENTION

No intervention will be applied to the control group.

Interventions

It consists of 8 sessions in total. It is planned as once a week and 45 minutes.

intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Providing informal care to an individual with mild or moderate Alzheimer's disease
  • Being a primary caregiver
  • Having been caring for the patient for at least 6 months
  • Providing care to the patient for at least 6 hours a day
  • The caregiver is 18 years or older
  • Residency of the caregiver in the province of Ankara
  • Willingness and volunteering to participate in the research

You may not qualify if:

  • Hearing and understanding difficulties
  • Having a psychiatric disorder
  • Receiving any therapy services
  • Caregivers who did not attend two or more of the eight interviews were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Konyaaltı, 07070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alzheimer DiseaseCaregiver BurdenPsychological Well-Being

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersStress, PsychologicalBehavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Hande Kirisik, Lecturer

    Ankara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 14, 2023

Study Start

October 4, 2023

Primary Completion

November 22, 2023

Study Completion

November 22, 2023

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations