NCT07289009

Brief Summary

This study was designed with a methodological approach. The first phase of the study consists of establishing the validity and reliability of the "International Resident Assessment Instrument-Home Care (InterRAI-HC)" application in Turkish. The second phase of the study involves comparing the standard forms used in Home Health Services units with the adapted InterRAI scale. The study population will consist of caregivers of individuals aged 65 and over who apply to the home health services unit of a healthcare institution in Kars province. The interRAI-HC questionnaire, SF-12 scale, and nursing care plans will be used to collect data. The aim of the study is to develop a comprehensive geriatric assessment tool for use in home health services.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Progress55%
Jan 2026Jul 2026

First Submitted

Initial submission to the registry

November 26, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 25, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Expected
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

November 26, 2025

Last Update Submit

December 16, 2025

Conditions

Keywords

Home Health CareOlder AdultsNursing CareQuality of Life

Outcome Measures

Primary Outcomes (1)

  • SF-12

    The SF-36 Scale consists of 12 selected questions from the SF-36 Questionnaire. In 1992, the Rand Corporation developed and released the SF-36 Health Survey. Koçyiğit and colleagues established its validity and reliability in Turkish. The SF-12 consists of eight subscales. Scores ranging from 0 to 100 can be obtained from the scale. Higher scores indicate a higher quality of life.

    6 months

Study Arms (2)

Care-Centered Group

EXPERIMENTAL

Scale-focused care will be provided to this group. The care process will be maintained using care plans developed by the researcher based on literature information, including NANDA diagnoses, NIC interventions, and NOC outcomes.

Behavioral: Care supports

Control Group

NO INTERVENTION

This group will receive standard nursing care.

Interventions

Care supportsBEHAVIORAL

The intervention of the study involves providing nursing care to the elderly individual and caregivers using care plans designed by the researcher, utilizing a validated scale. The adapted scale provides a comprehensive geriatric assessment. Emerging issues will be evaluated using NANDA diagnoses and NIC interventions/NOC outcomes. Individuals in the intervention group will be followed up for 6 months with these care plans. No interventions other than the services provided under ESH will be performed on individuals in the control group. The adapted questionnaire and specified scales will be administered simultaneously at the initial interview (0 months) and at 6 months for individuals in this group.

Also known as: individual-centered nursing care
Care-Centered Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Being registered with ESYS (Home Health Care Management System),
  • Volunteering to participate in the study
  • Having a caregiver

You may not qualify if:

  • Not knowing Turkish
  • Withdrawal criteria from the study:
  • Refusing two or more scheduled visits,
  • Withdrawing at the individual's own request,
  • Providing incomplete or incorrect responses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harakani State Hospital

Kars, Merkez, 36100, Turkey (Türkiye)

Location

Central Study Contacts

Ikbal Oğuz Karaalp, PhD Candidate, RN

CONTACT

Bilge Kalanlar, Associate Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants included in the study will be assigned to intervention and control groups using a stratified randomization method based on the home health care units to which their caregivers belong. To ensure homogeneity between groups, "care unit and participant age" will be taken into account. Participants will first be stratified by age and care unit. Which group will be included in the Turkish validity and reliability study of the InterRAI-HC application (intervention) or the comparison of the InterRAI scale with standard forms (control) will be determined by lottery before assignment. Group "A" represents the InterRAI-HC application group, and group "B" represents the control group. To prevent selection bias, randomization will be performed using a sequence of random integers generated by a bio-statistician independent of the study using a computer. Participants will then be assigned to the intervention (n=18) and control (n=18) groups using simple randomization. Neither participant
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study is designed methodological research. The first stage is the validity-reliability stage. In the second stage, a randomized controlled trial will be conducted to measure the effectiveness of the adapted scale. The intervention group will receive care using the adapted scale, while the control group will receive standard care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Nurse, PhD Candidate

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 17, 2025

Study Start

January 25, 2026

Primary Completion

March 20, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations