NCT07672340

Brief Summary

This randomized controlled trial will be conducted to examine the effect of a multidimensional training program, to be implemented by a public health nurse, on the care burden and quality of life of primary caregivers of patients aged 65 and older.

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
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

May 8, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

May 8, 2026

Last Update Submit

June 24, 2026

Conditions

Caregiver BurdenQuality of LifePublic Health

Outcome Measures

Primary Outcomes (2)

  • Before intervention caregiving burden

    The Caregiver Burden Scale will be used to assess the stress experienced by caregivers. It consists of 22 statements that evaluate the impact of caregiving on the caregiver's life and uses a Likert-type scale. The scale's highest score is 88, and the lowest is 0. Higher scores are associated with an increased caregiving burden.

    Before intervention

  • After intervention caregiving burden

    The Caregiver Burden Scale will be used to assess the stress experienced by caregivers. It consists of 22 statements that assess the impact of caregiving on the caregiver's life and uses a Likert-type scale. The maximum score on the scale is 88, and the minimum is 0. Higher scores are associated with increased caregiving burden.

    1 week after intervention

Secondary Outcomes (2)

  • Before intervention

    Before intervention

  • After intervention

    1 week after intervention

Study Arms (2)

Control group

NO INTERVENTION

The control group continued to receive the routine care

Structured education

EXPERIMENTAL

Caregivers in the intervention groups will undergo a four-session intervention program in addition to the routine care provided by other caregivers. The training, which is planned to last four weeks and includes activities aimed at reducing the impact of the caregiving role on caregivers, involves the delivery of a training program designed to improve caregivers' adaptation to their caregiving roles.

Behavioral: Health Promotion Behavior Education

Interventions

Health Promotion Behavior EducationBEHAVIORAL

Personal hygiene, hand hygiene, Musculoskeletal system, body mechanics, relaxation exercises, the importance of physical activity, Proper and healthy nutrition, foods to increase and decrease consumption of, food safety and hygiene, Sleep health, sleep hygiene, the importance of sleep in human life, sleep quality, sleep duration, and factors affecting sleep, Early detection methods, adult immunization, rational use of medications, Safe environment and home accidents.

Also known as: Social health dimension, Physical health, Psychological health dimension, Emotional health dimension
Structured education

Eligibility Criteria

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

You may qualify if:

  • Be willing to participate in the study
  • Be literate
  • Have registered with a home health care unit
  • Have been responsible for the care of a relative aged 65 or older for at least one month
  • Score at least 21 on the Zarit Caregiver Burden Scale

You may not qualify if:

  • Having severe reading comprehension difficulties
  • Having severe hearing difficulties
  • Having been diagnosed with a psychiatric disorder (schizophrenia, bipolar disorder, or anxiety disorder)
  • Failing to complete the data collection instruments used in the study
  • Failing to attend at least two training sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Central Study Contacts

Dilek Hassoy

CONTACT

+905054829071dihassoy09@gmail.com

Safiye Özvurmaz, professor

CONTACT

+90 5374746531sozvurmaz@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

May 8, 2026

First Posted

June 26, 2026

Study Start

July 1, 2026

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

June 26, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share