NCT07672366

Brief Summary

This study was designed to investigate the effects of a person-centered occupational therapy approach on quality of life and occupational balance among community-dwelling older adults. The study is a randomized controlled trial utilizing semi-structured interviews and self-report measures. The target population consists of individuals aged 65 years and older living in Istanbul. The sample size was calculated using G\*Power software, indicating a minimum of 77 participants per group, for a total of 154 participants. Considering potential attrition, a total sample of 170 participants is planned. Data will be collected using a Sociodemographic Information Form, the Mini-Mental State Examination (MMSE), the Occupational Performance History Interview-II (OPHI-II), Goal Attainment Scaling (GAS), the World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD), and the Activity-Role Balance Questionnaire. Cognitive eligibility will be assessed using the MMSE, and individuals scoring 24 or higher will be included in the study. Through the OPHI-II, participants' life histories, roles, habits, and experiences related to daily activities will be explored, and individualized goals will be identified based on the information obtained. These goals will subsequently be structured using the Goal Attainment Scaling method. Participants will be randomly allocated to either the intervention group or the control group. Participants in the intervention group will receive person-centered occupational therapy sessions delivered via telerehabilitation, while those in the control group will continue their usual daily routines without additional support. At the end of the study, outcomes related to quality of life and occupational balance will be compared between groups. The findings are expected to provide evidence regarding the role of a person-centered occupational therapy approach in supporting participation in daily life activities among older adults.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

April 15, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
1 month 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

3 months

First QC Date

June 14, 2026

Last Update Submit

June 24, 2026

Conditions

Keywords

older adultsperson-centeredoccupational therapylife satisfactionoccupational balance

Outcome Measures

Primary Outcomes (2)

  • World Health Organization Quality of Life Instrument-Older Adults Module

    Quality of life will be assessed using the World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD). The scale consists of 24 items and evaluates quality of life in older adults across six domains: sensory abilities, autonomy, past-present-future activities, social participation, death and dying, and intimacy. Total scores range from 24 to 120, with higher scores indicating better quality of life. The outcome will be the change in the total WHOQOL-OLD score from baseline to post-intervention

    Baseline and immediately after completion of the 6-week intervention period

  • Activity-Role Balance Questionnaire

    Occupational balance will be assessed using the Activity-Role Balance Questionnaire. This self-report questionnaire consists of 11 items and evaluates individuals' perceived balance among daily activities and roles. Total scores range from 0 to 33, with higher scores indicating a higher level of perceived occupational balance. The outcome will be the change in the total Activity-Role Balance Questionnaire score from baseline to post-intervention.

    Baseline and immediately after completion of the 6-week intervention period.

Secondary Outcomes (1)

  • Goal Attainment Scaling

    Immediately after completion of the 6-week intervention period.

Study Arms (2)

Experimental Group: Person-Centered Occupational Therapy via Telerehabilitation

EXPERIMENTAL

Participants assigned to the experimental group will receive a person-centered occupational therapy program delivered through telerehabilitation. The intervention will consist of one 40-minute online session per week for six consecutive weeks. Session content will be individualized based on information obtained from the Occupational Performance History Interview-II (OPHI-II), participants' daily routines, occupational roles, meaningful activities, environmental contexts, and collaboratively identified goals. Goal Attainment Scaling (GAS) will be used to structure individualized goals and monitor progress throughout the study period.

Behavioral: Person-Centered Occupational Therapy Approach Delivered via Telerehabilitation

Control Group: Usual Daily Routine

NO INTERVENTION

Participants assigned to the control group will not receive any occupational therapy intervention during the study period. They will continue their usual daily routines and activities without additional support, guidance, or structured sessions. Outcome measures will be collected at the same assessment time points as the experimental group.

Interventions

The intervention consists of a person-centered occupational therapy approach delivered through telerehabilitation. Following the Occupational Performance History Interview-II (OPHI-II), individualized goals are collaboratively established based on each participant's occupational history, daily routines, roles, meaningful activities, environmental context, and personal priorities. Goals are structured using Goal Attainment Scaling (GAS). Participants receive one 40-minute online session per week for six weeks. Sessions focus on supporting participation in meaningful activities, improving occupational balance, enhancing social participation, strengthening role engagement, promoting self-management strategies, and facilitating adaptations to daily routines and environmental demands according to individual needs.

Experimental Group: Person-Centered Occupational Therapy via Telerehabilitation

Eligibility Criteria

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

You may qualify if:

  • Aged 65 years or older.
  • Living independently in the community.
  • Scoring 24 or higher on the Mini-Mental State Examination (MMSE).
  • Having sufficient communication abilities to participate in interviews and assessments.
  • Willing to participate and provide informed consent.

You may not qualify if:

  • Having an acute medical or psychiatric condition that may prevent participation in the study.
  • Having communication difficulties that interfere with participation despite the use of assistive devices (e.g., hearing aids, glasses).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlas University

Istanbul, Kağıthane, 34408, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Zeynep Çorakcı Yazıcıoğlu

CONTACT

Ceren Davutoğlu

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned in parallel to one of two study groups: a person-centered occupational therapy group delivered via telerehabilitation or a control group receiving usual daily activities without additional intervention. Participants in the intervention group receive one 40-minute telerehabilitation session per week for six consecutive weeks. The content of the sessions is individualized according to each participant's occupational history, daily routines, meaningful activities, and personally identified goals. Participants in the control group continue their usual daily routines throughout the study period. Outcome measures are assessed at baseline and immediately after the six-week study period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 14, 2026

First Posted

June 26, 2026

Study Start

April 15, 2026

Primary Completion

July 1, 2026

Study Completion

August 1, 2026

Last Updated

June 26, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations