Disability PhysicalIADLINCT05790798
The Effect of Occupational Therapy-Based Instrumental Activities of Daily Living Intervention in People With Disabilities
A study testing occupational therapy-based instrumental daily living activities intervention and Quite recreation activity in people with Disability Physical, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Disability Physical
- What is being tested?
- occupational therapy-based instrumental daily living activities intervention and Quite recreation activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2022to 16 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- not participating regularly in the intervention program.
- Having a communication problem that prevented the participant from completing the assessment and the kits;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Occupational Therapy-Based Instrumental Activities of Daily Living Intervention on Stress Level, Quality of Life, and Participation in People With Disabilities
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.
Read the detailed description
The concept of disability refers to the limitation in activity and social participation and loss of function due to the inability to fulfill the roles expected from the people depending on the level of development, sex, and social factors resulting from an impairment or handicap. The number of people with disabilities is increasing daily in the world, and it was determined that 15.6% of the population over 18 has a disability. People with disabilities experience problems in activities such as bathing, dressing, eating, shopping, money management, preparing food, cleaning, and using drugs, due to physical, cognitive, sensory, and psychosocial impairments. The above-mentioned activities are the tasks of everyday life called activities of daily living (ADL). ADLs are classified as basic activities of daily living (basic ADLs; bathing, eating, toilet, etc.), and instrumental activities of daily living (IADLs; shopping, money management, meal preparation, shopping, dog walking, paying bills, etc.).
People with disabilities need IADLs to a large extent in order to continue living more independently in the community. IADLs are meaningful and purposeful activities that give meaning to people's lives and reflect their social values and cultures. IADLs include activities such as taking care of others, using public transport, health management, and household chores, and have a more complex structure than basic ADLs. Unlike basic ADLs, IADLs require more complex cognitive skills such as planning, organization, decision-making, and executive functions, or fine motor, visual sharpness, or hearing skills. In addition, IADLs are also affected by contextual factors (age, sex, habits, education, culture, environment, etc.) independently of daily living activities. Because IADLs are carried out in many social areas outside the home and include activities based on the people's home, work, school, and social participation. Factors such as environmental suitability, social stigma, and stress of people with disabilities, limit participation in their IADLs and negatively affect their quality of life. Therefore, it is seen that low social participation, decreased quality of life, and increased perceived stress are closely related to IADL performance problems.
In the literature, it is seen that intervention methods are used to improve the IADLs of people with disabilities. Clarke et al. implemented an 8-week physiotherapy and occupational therapy-based intervention program in people with mild and moderate Parkinson's disease (n=762). They made individualized practices on sleep, fatigue, personal care, dressing, in-home mobility, housework, and environmental problems within the scope of the intervention. As a result, it was observed that there was a significant increase in IADL performance, and they recommended the use of activity-based intensified intervention programs for future studies. In a survey study conducted with 105 hand therapists in the USA, 97% of therapists stated that interventions that include meaningful and purposeful activities would be more beneficial for people with upper extremity problems, rather than traditional intervention programs using physical agent modalities or progressive resistance exercises. Egan et al. reported a significant increase in the performance and satisfaction levels of self-care, productivity and leisure activities of the therapy group in the activity-based intervention program applied to improve the occupational performance of 16 people with stroke. Studies with high levels of evidence have emphasized that the use of the daily living activities in intervention programs improves the quality of life of people with disabilities. Politis et al. implemented a 4-week kit-based intervention that included activities of daily living for 37 people with dementia. As a result of the intervention, it was found that the increased quality of life and decreased apathy in people with dementia. It has been stated that the use of kits in intervention programs is relatively inexpensive compared to traditional intervention programs, it is colorful and interesting, is enthusiastically welcomed by people, and it is easy to build. In another study, it was determined that 10 activity kits used to improve the leisure activities of people with Alzheimer's and dementia living in nursing homes increased the quality of life of people.
In occupational therapy, Dy and Yancosek, who developed IADLs kits consisting of daily living activities, created an 8-week intervention program within the scope of hand rehabilitation. Activity kits were used to examine the personal opinions of occupational therapists in terms of the ease of application of the kits before and after they were applied to people. As a result, the use of activity kits in evaluation and interventions has been suggested because they are easy and functional compared to biomechanical intervention programs. Berlet and Kaskutas prepared 10 activity kits in the hand therapy clinic for 642 people who have undergone hand surgery, for the areas of basic and instrumental ADLs where they have the most difficulty. They sent the prepared kits to 30 occupational therapists working in the fields of hand and community rehabilitation and received their opinions about these kits. Occupational therapists stated that the kits eliminate the waste of time in building the materials to be used during the intervention and increase the efficiency of the intervention as it deals with the occupational performance of the kits.
In the systematic reviews, it is seen that studies examining the effects of interventions for IADLs are more common in the elderly and that IADL interventions for people with disabilities are limited. In addition, in studies with IADL kits, programs that develop fine motor skills were focused on. According to the studies, it was thought that the proposed IADL interventions to increase the independence of individuals with disabilities should be planned with a new approach. Therefore, it was aimed to examine the effect of the intervention to be made with the kits created for IADLs on people with disabilities. Specifically, The aim of this study was to investigate the effect of occupational therapy-based instrumental activities of daily living intervention on stress levels, quality of life, and participation in people with disabilities.
- Conditions
- Disability Physical
- Being tested
- occupational therapy-based instrumental daily living activities intervention, Quite recreation activity
- Keywords
- Participation, Stress Level, Quality of Life, Instrumental Activities of Daily Living
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occupational therapy-based instrumental daily living activities interventionOther
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.
Quite recreation activityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Quite recreation activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (5)
Waisman Activities of Daily Living Scale (W-ADL):
It is a scale developed according to the measurement criteria in the literature to measure the ADL of adolescents and adults with developmental disorders (Maenner et al., 2013). It aims to measure the level of independence while performing typical daily living activities in developmental disorders.
Measured: 8 weeks
Modified Mini-Mental State Examination Test (MMSE-E):
It was created by Folstein et al. (1975) with the aim of evaluating the cognitive skills of people. The validity and reliability study were conducted by Babacan et al. (2014) for the Turkish population.
Measured: 8 weeks
SF-36 Health Survey Questionnaire:
The SF-36 assesses quality of life without being specific to any age, disease, or treatment group. It includes 36 questions in eight sub-dimensions: Physical Functioning, Social Functioning, Role Limitations (Physical Problems, Emotional Problems), Vitality, Bodily Pain, General Health Perceptions, and General Mental Health (Ware et al., 1993).
Measured: 8 weeks
Perceived Stress Scale (PSS):
The Perceived Stress Scale (PSS) developed by Cohen et al. (1997). Consisting of 14 items in total, PSS is designed to measure how stressful a person's life is perceived to be. Participants evaluate each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)".
Measured: 8 weeks
Community Integration Questionnaire (CIQ):
This questionnaire developed by Willer et al. (1993) to assess community participation. The CIQ consists of 15 questions that assess a person's participation in home and family life, social and productive activities.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start15 Sep 2022
- Primary completion15 Feb 2023
- Study completion16 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disability PhysicalStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokcen Akyurek, Hacettepe University
- Investigators
- Gokcen Akyurek, Phd, Principal investigator, Assoc Prof
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790798
- Sponsor's protocol ID
- 59.2023fbu
- Acronym
- IADLI
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available from the corresponding author, upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Occupational Therapy-Based Instrumental Activities of Daily Living Intervention on Stress Level, Quality of Life, and Participation in People With Disabilities
- ClinicalTrials.gov ID
- NCT05790798
- Acronym / sponsor ID
- IADLI / 59.2023fbu
- Conditions
- Disability Physical
- Keywords
- Participation, Stress Level, Quality of Life, Instrumental Activities of Daily Living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The concept of disability refers to the limitation in activity and social participation and loss of function due to the inability to fulfill the roles expected from the people depending on the level of development, sex, and social factors resulting from an impairment or handicap. The number of people with disabilities is increasing daily in the world, and it was determined that 15.6% of the population over 18 has a disability. People with disabilities experience problems in activities such as bathing, dressing, eating, shopping, money management, preparing food, cleaning, and using drugs, due to physical, cognitive, sensory, and psychosocial impairments. The above-mentioned activities are the tasks of everyday life called activities of daily living (ADL). ADLs are classified as basic activities of daily living (basic ADLs; bathing, eating, toilet, etc.), and instrumental activities of daily living (IADLs; shopping, money management, meal preparation, shopping, dog walking, paying bills, etc.).
People with disabilities need IADLs to a large extent in order to continue living more independently in the community. IADLs are meaningful and purposeful activities that give meaning to people's lives and reflect their social values and cultures. IADLs include activities such as taking care of others, using public transport, health management, and household chores, and have a more complex structure than basic ADLs. Unlike basic ADLs, IADLs require more complex cognitive skills such as planning, organization, decision-making, and executive functions, or fine motor, visual sharpness, or hearing skills. In addition, IADLs are also affected by contextual factors (age, sex, habits, education, culture, environment, etc.) independently of daily living activities. Because IADLs are carried out in many social areas outside the home and include activities based on the people's home, work, school, and social participation. Factors such as environmental suitability, social stigma, and stress of people with disabilities, limit participation in their IADLs and negatively affect their quality of life. Therefore, it is seen that low social participation, decreased quality of life, and increased perceived stress are closely related to IADL performance problems.
In the literature, it is seen that intervention methods are used to improve the IADLs of people with disabilities. Clarke et al. implemented an 8-week physiotherapy and occupational therapy-based intervention program in people with mild and moderate Parkinson's disease (n=762). They made individualized practices on sleep, fatigue, personal care, dressing, in-home mobility, housework, and environmental problems within the scope of the intervention. As a result, it was observed that there was a significant increase in IADL performance, and they recommended the use of activity-based intensified intervention programs for future studies. In a survey study conducted with 105 hand therapists in the USA, 97% of therapists stated that interventions that include meaningful and purposeful activities would be more beneficial for people with upper extremity problems, rather than traditional intervention programs using physical agent modalities or progressive resistance exercises. Egan et al. reported a significant increase in the performance and satisfaction levels of self-care, productivity and leisure activities of the therapy group in the activity-based intervention program applied to improve the occupational performance of 16 people with stroke. Studies with high levels of evidence have emphasized that the use of the daily living activities in intervention programs improves the quality of life of people with disabilities. Politis et al. implemented a 4-week kit-based intervention that included activities of daily living for 37 people with dementia. As a result of the intervention, it was found that the increased quality of life and decreased apathy in people with dementia. It has been stated that the use of kits in intervention programs is relatively inexpensive compared to traditional intervention programs, it is colorful and interesting, is enthusiastically welcomed by people, and it is easy to build. In another study, it was determined that 10 activity kits used to improve the leisure activities of people with Alzheimer's and dementia living in nursing homes increased the quality of life of people.
In occupational therapy, Dy and Yancosek, who developed IADLs kits consisting of daily living activities, created an 8-week intervention program within the scope of hand rehabilitation. Activity kits were used to examine the personal opinions of occupational therapists in terms of the ease of application of the kits before and after they were applied to people. As a result, the use of activity kits in evaluation and interventions has been suggested because they are easy and functional compared to biomechanical intervention programs. Berlet and Kaskutas prepared 10 activity kits in the hand therapy clinic for 642 people who have undergone hand surgery, for the areas of basic and instrumental ADLs where they have the most difficulty. They sent the prepared kits to 30 occupational therapists working in the fields of hand and community rehabilitation and received their opinions about these kits. Occupational therapists stated that the kits eliminate the waste of time in building the materials to be used during the intervention and increase the efficiency of the intervention as it deals with the occupational performance of the kits.
In the systematic reviews, it is seen that studies examining the effects of interventions for IADLs are more common in the elderly and that IADL interventions for people with disabilities are limited. In addition, in studies with IADL kits, programs that develop fine motor skills were focused on. According to the studies, it was thought that the proposed IADL interventions to increase the independence of individuals with disabilities should be planned with a new approach. Therefore, it was aimed to examine the effect of the intervention to be made with the kits created for IADLs on people with disabilities. Specifically, The aim of this study was to investigate the effect of occupational therapy-based instrumental activities of daily living intervention on stress levels, quality of life, and participation in people with disabilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: occupational therapy-based instrumental daily living activities interventionThe 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. |
| Control Group | Active comparator | Other: Quite recreation activityThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- not participating regularly in the intervention program.
- Having a communication problem that prevented the participant from completing the assessment and the kits;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| occupational therapy-based instrumental daily living activities interventionOccupational 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. | Other | intervention group |
| Quite recreation activityFor 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. | Other | Control Group |
Primary outcome
Lawton-Brody Instrumental Activities of Daily Living Scale
Time frame: 8 weeks
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.
5 secondary outcomes
Waisman Activities of Daily Living Scale (W-ADL):
Time frame: 8 weeks
Modified Mini-Mental State Examination Test (MMSE-E):
Time frame: 8 weeks
SF-36 Health Survey Questionnaire:
Time frame: 8 weeks
Perceived Stress Scale (PSS):
Time frame: 8 weeks
Community Integration Questionnaire (CIQ):
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available from the corresponding author, upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gokcen Akyurek, Phd principal investigator
Assoc Prof
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing occupational therapy-based instrumental daily living activities intervention and Quite recreation activity in people with Disability Physical, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lawton-Brody Instrumental Activities of Daily Living Scale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.