- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07672366
Person-Centered Occupational Therapy in Older Adults
Effects of a Person-Centered Occupational Therapy Approach on Life Satisfaction and Occupational Balance in Older Adults: A Randomized Controlled Trial
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The global increase in the older adult population has highlighted the importance of interventions that support healthy aging, participation in meaningful activities, and quality of life. Aging is often accompanied by changes in physical, cognitive, and social functioning that may negatively affect participation in daily activities, occupational balance, and overall well-being. Occupational therapy aims to support individuals in maintaining participation in meaningful occupations and adapting to age-related changes in daily life.
Person-centered occupational therapy is an approach that emphasizes the individual's values, preferences, life experiences, goals, and priorities throughout the therapeutic process. By focusing on personally meaningful activities and roles, this approach seeks to enhance engagement, autonomy, and quality of life. Despite the growing recognition of person-centered care in geriatric practice, there remains limited evidence regarding the effectiveness of person-centered occupational therapy interventions delivered through telerehabilitation among community-dwelling older adults.
The present study aims to investigate the effects of a person-centered occupational therapy approach on quality of life and occupational balance in community-dwelling older adults. Participants aged 65 years and older will be recruited from the community and screened for eligibility. Cognitive status will be evaluated using the Mini-Mental State Examination (MMSE), and individuals scoring 24 or above will be eligible to participate.
At baseline, participants will complete a Sociodemographic Information Form, the Occupational Performance History Interview-II (OPHI-II), the World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD), and the Activity-Role Balance Questionnaire. Through the OPHI-II, participants' occupational histories, life experiences, daily routines, habits, roles, environmental contexts, and occupational participation patterns will be explored. Based on the information obtained during the interview, individualized goals will be collaboratively established with each participant and structured using the Goal Attainment Scaling (GAS) methodology.
Following baseline assessment, participants will be randomly assigned to either the intervention group or the control group. Participants in the intervention group will receive person-centered occupational therapy sessions delivered via telerehabilitation. The content of these sessions will be individualized according to each participant's occupational history, identified needs, personal goals, daily routines, meaningful activities, and environmental circumstances. The sessions will focus on supporting participation in meaningful activities, improving occupational balance, strengthening role engagement, promoting social participation, enhancing self-management strategies, and facilitating adaptations within the participant's daily environment when necessary.
Participants in the control group will continue their usual daily routines and will not receive person-centered occupational therapy during the study period. Upon completion of the intervention period, all participants will be reassessed using the WHOQOL-OLD, Activity-Role Balance Questionnaire, and Goal Attainment Scaling.
The primary outcome of the study is quality of life as measured by the WHOQOL-OLD. Secondary outcomes include occupational balance and goal attainment. The findings are expected to contribute to the evidence base regarding the effectiveness of person-centered occupational therapy delivered through telerehabilitation and provide guidance for occupational therapy services aimed at supporting healthy aging and participation among older adults living in the community.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Kağıthane
-
Istanbul, Kağıthane, Tyrkia (Türkiye), 34408
- Atlas University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Experimental Group: Person-Centered Occupational Therapy via Telerehabilitation
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.
|
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.
|
|
Ingen inngripen: Control Group: Usual Daily Routine
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
World Health Organization Quality of Life Instrument-Older Adults Module
Tidsramme: Baseline and immediately after completion of the 6-week intervention period
|
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
Tidsramme: Baseline and immediately after completion of the 6-week intervention period.
|
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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Goal Attainment Scaling
Tidsramme: Immediately after completion of the 6-week intervention period.
|
Goal attainment will be assessed using Goal Attainment Scaling (GAS).
Individualized goals will be established collaboratively with each participant based on the Occupational Performance History Interview-II and personal priorities.
Each goal will be rated on a five-point scale ranging from -2 to +2, where 0 represents the expected level of goal achievement.
Higher scores indicate greater goal attainment.
The outcome will be the level of goal achievement at the end of the intervention period.
|
Immediately after completion of the 6-week intervention period.
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Yazicioglu_2
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .