NCT05790798

Brief Summary

The aim of this study was to investigate the effects of occupational therapy-based instrumental activities of daily living intervention on stress levels, quality of life, and participation in people with disability. The participants were recruited from the Etimesgut Family and Life Center in Ankara. In this study, an individualized occupational therapy-based instrumental activities of daily living intervention were implemented for a total of 8 weeks, lasting 16 sessions, which included an intervention group (n=9) and a control group (n=9). Changes before and after the intervention were assessed with the Lawton-Brody Instrumental Activities of Daily Living Scale, Waisman Activities of Daily Living Scale, Modified Mini-Mental State Examination Test, SF-36 Health Survey Questionnaire, Perceived Stress Scale, and Community Integration Questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

September 15, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

March 16, 2023

Last Update Submit

March 29, 2023

Conditions

Keywords

ParticipationStress LevelQuality of LifeInstrumental Activities of Daily Living

Outcome Measures

Primary Outcomes (1)

  • Lawton-Brody Instrumental Activities of Daily Living Scale

    It consists of 8 questions including information about telephone use, meal preparation, shopping, doing daily household chores, laundry, getting on transportation, traveling, medication use and management of finances.

    8 weeks

Secondary Outcomes (5)

  • Waisman Activities of Daily Living Scale (W-ADL):

    8 weeks

  • Modified Mini-Mental State Examination Test (MMSE-E):

    8 weeks

  • SF-36 Health Survey Questionnaire:

    8 weeks

  • Perceived Stress Scale (PSS):

    8 weeks

  • Community Integration Questionnaire (CIQ):

    8 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

The universe of this research, which has a randomized controlled design, is all people with disabilities aged 18 and older who are attended at the Etimesgut Family and Life Center in Ankara. The inclusion criteria of this study were to be 18 years of age or older, to have a score of 17 and below according to the Lawton-Brody Instrumental Activity of Daily Living Scale, to have a score of 24 and above in the Modified Mini-Mental test. In addition, there are some exclusion criteria for research. Exclusion criteria from the study were: Having a communication problem that prevented the participant from completing the assessment and the kits; not participating regularly in the intervention program. For this study, people who attended the Family and Life Center and people with disabilities who regularly come to this center for various reasons were contacted. People (n=35) who met the criteria of the study were informed about the study and invited to participate in this study.

Other: occupational therapy-based instrumental daily living activities intervention

Control Group

ACTIVE COMPARATOR

The universe of this research, which has a randomized controlled design, is all people with disabilities aged 18 and older who are attended at the Etimesgut Family and Life Center in Ankara. The inclusion criteria of this study were to be 18 years of age or older, to have a score of 17 and below according to the Lawton-Brody Instrumental Activity of Daily Living Scale, to have a score of 24 and above in the Modified Mini-Mental test. In addition, there are some exclusion criteria for research. Exclusion criteria from the study were: Having a communication problem that prevented the participant from completing the assessment and the kits; not participating regularly in the intervention program. For this study, people who attended the Family and Life Center and people with disabilities who regularly come to this center for various reasons were contacted. People (n=35) who met the criteria of the study were informed about the study and invited to participate in this study.

Other: Quite recreation activity

Interventions

Occupational therapy-based instrumental activities of daily living intervention were applied to 9 people with disabilities in the intervention group, with sessions consisting of 45 minutes twice a week (totally 8 weeks/16 sessions). While the activity intervention program was being created for the intervention group, the problem areas in the ADL and IADL determined by the evaluations made before the intervention were identified. Ten occupation kits including 2 ADLs (dressing and feeding nutrition), and 8 IADLs (laundry, meal preparation, light cleaning, paperwork, use of technology, lifting and carrying, fine motor and gross motor leisure groups) were used as interventions. Various materials (jar, shirt, spoon, teapot, play dough, stapler, plastic bag, sponge, etc.) were prepared to be used in each occupation kit and to simulate daily activities.

intervention group

For the control group, information about the scope, duration and requirements of the research was shared throughout the process. During this period, reading activities continued. The final evaluation of all participants was made at the end of the 8th week of the study and the study was completed.

Control Group

Eligibility Criteria

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

You may qualify if:

  • were to be 18 years of age or older,
  • to have a score of 17 and below according to the Lawton-Brody Instrumental Activity of Daily Living Scale,
  • to have a score of 24 and above in the Modified Mini-Mental test.

You may not qualify if:

  • not participating regularly in the intervention program.
  • Having a communication problem that prevented the participant from completing the assessment and the kits;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Study Officials

  • Gokcen Akyurek, Phd

    Assoc Prof

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

March 16, 2023

First Posted

March 30, 2023

Study Start

September 15, 2022

Primary Completion

February 15, 2023

Study Completion

March 16, 2023

Last Updated

March 30, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

The data that support the findings of this study are available from the corresponding author, upon reasonable request.

Locations