Multiple SclerosisNCT07842744
Multiple Sclerosis Severity and Caregiver Health Outcomes
An observational study of Multiple Sclerosis and Caregiver Burden, run by Süleyman Korkusuz at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional observational study aims to investigate the associations between multiple sclerosis (MS) severity and caregivers' sleep quality, physical activity, body awareness, perceived stress, and caregiver burden. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Caregiver Burden, Sleep Quality
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2026to 20 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will consist of 68 adult caregivers of individuals diagnosed with multiple sclerosis who receive care at Başkent University Hospital. Caregivers will be recruited to evaluate the associations between MS severity and caregiver health outcomes.
Who may be able to join
- Being 18 years of age or older.
- Providing regular care to an individual diagnosed with multiple sclerosis for at least six months.
- Volunteering to participate in the study.
Who cannot join
- Having a cognitive impairment that prevents completion of the assessments.
- Having a severe physical or psychiatric condition that may interfere with study assessments.
- Being unable to complete the questionnaires.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Atılım University
Ankara
Süleyman Korkusuz, PhD, +90 538 867 54 80, suleyman.korkusuz@atilim.edu.tr
About this study
Official title: Associations Between Multiple Sclerosis Severity and Caregivers' Sleep Quality, Physical Activity, Body Awareness, Psychosocial Status, and Caregiver Burden: An ICF-Based Cross-Sectional Study
This cross-sectional observational study aims to investigate the associations between multiple sclerosis (MS) severity and caregivers' sleep quality, physical activity, body awareness, perceived stress, and caregiver burden. A total of 68 caregivers of patients with MS will be recruited from Başkent University Hospital. MS severity will be assessed using the Expanded Disability Status Scale (EDSS), while caregiver health outcomes will be evaluated using validated questionnaires. The findings are expected to provide insight into the multidimensional impact of MS severity on caregiver health and well-being.
Read the detailed description
This cross-sectional observational study aims to investigate the associations between multiple sclerosis (MS) severity and caregivers' sleep quality, physical activity, body awareness, perceived stress, and caregiver burden.
A total of 68 caregivers of individuals with MS will be included. Disease severity will be assessed using the Expanded Disability Status Scale (EDSS). Caregiver outcomes will be evaluated using the Pittsburgh Sleep Quality Index (PSQI), International Physical Activity Questionnaire-Short Form (IPAQ-SF), Body Awareness Questionnaire (BAQ), Perceived Stress Scale (PSS), and Zarit Burden Interview (ZBI).
The study will examine the relationships between MS severity and caregiver health outcomes within the framework of the International Classification of Functioning, Disability and Health (ICF). No therapeutic intervention will be administered.
- Conditions
- Multiple Sclerosis, Caregiver Burden, Sleep Quality, Physical Activity, Psychological Stress
- Medical subject headings
- Multiple Sclerosis, Caregiver Burden, Sleep Initiation and Maintenance Disorders, Motor Activity, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Caregivers of Patients With Multiple Sclerosis | Adult caregivers who have provided regular care to a person diagnosed with multiple sclerosis for at least six months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Burden (Zarit Burden Interview)
Caregiver burden will be assessed using the Zarit Burden Interview (ZBI). Higher scores indicate greater perceived caregiver burden.
Measured: Baseline
Secondary outcomes (4)
Sleep Quality (Pittsburgh Sleep Quality Index)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 to 21, with higher scores indicating poorer sleep quality. Scores above 5 indicate poor sleep quality.
Measured: Baseline
Physical Activity (IPAQ-SF)
Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). Total physical activity will be expressed as metabolic equivalent of task minutes per week (MET-min/week) based on activities performed during the previous seven days. Total MET-min/week is calculated as the sum of walking (3.3 METs × minutes × days), moderate-intensity activity (4.0 METs × minutes × days), and vigorous-intensity activity (8.0 METs × minutes × days). The minimum possible value is 0 MET-min/week; there is no fixed maximum score. Higher MET-min/week values indicate a higher level of physical activity and therefore a better outcome.
Measured: Baseline
Body Awareness (Body Awareness Questionnaire)
Body awareness will be assessed using the 18-item Body Awareness Questionnaire (BAQ). Each item is rated on a 7-point Likert scale from 1 to 7, yielding a total score ranging from 18 to 126. Higher scores indicate greater body awareness and therefore a better outcome
Measured: Baseline
Perceived Stress (Perceived Stress Scale)
Perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10). Total scores range from 0 to 40, with higher scores indicating greater perceived stress.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start20 Oct 2026 (estimated)
- Primary completion20 Jan 2027 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Süleyman Korkusuz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Süleyman Korkusuz, Atılım University
- Investigators
- Büşra S Korkusuz, Study chair, Ankara UniversityCemre Yılmaz, Study chair, Atılım UniversitySüleyman Korkusuz, Principal investigator, Atılım University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842744
- Sponsor's protocol ID
- E-59394181-604.01-126832
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khan F, Pallant J, Brand C. Caregiver strain and factors associated with caregiver self-efficacy and quality of life in a community cohort with multiple sclerosis. Disabil Rehabil. 2007 Aug 30;29(16):1241-50. doi: 10.1080/01443610600964141.
PubMed 17653999Maguire R, Maguire P. Caregiver Burden in Multiple Sclerosis: Recent Trends and Future Directions. Curr Neurol Neurosci Rep. 2020 May 22;20(7):18. doi: 10.1007/s11910-020-01043-5.
PubMed 32444986
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Multiple Sclerosis Severity and Caregivers' Sleep Quality, Physical Activity, Body Awareness, Psychosocial Status, and Caregiver Burden: An ICF-Based Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07842744
- Acronym / sponsor ID
- E-59394181-604.01-126832
- Conditions
- Multiple Sclerosis, Caregiver Burden, Sleep Quality, Physical Activity, Psychological Stress
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Süleyman KorkusuzUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 25 Sep 2026 (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.
This cross-sectional observational study aims to investigate the associations between multiple sclerosis (MS) severity and caregivers' sleep quality, physical activity, body awareness, perceived stress, and caregiver burden. A total of 68 caregivers of patients with MS will be recruited from Başkent University Hospital. MS severity will be assessed using the Expanded Disability Status Scale (EDSS), while caregiver health outcomes will be evaluated using validated questionnaires. The findings are expected to provide insight into the multidimensional impact of MS severity on caregiver health and well-being.
Detailed description
This cross-sectional observational study aims to investigate the associations between multiple sclerosis (MS) severity and caregivers' sleep quality, physical activity, body awareness, perceived stress, and caregiver burden.
A total of 68 caregivers of individuals with MS will be included. Disease severity will be assessed using the Expanded Disability Status Scale (EDSS). Caregiver outcomes will be evaluated using the Pittsburgh Sleep Quality Index (PSQI), International Physical Activity Questionnaire-Short Form (IPAQ-SF), Body Awareness Questionnaire (BAQ), Perceived Stress Scale (PSS), and Zarit Burden Interview (ZBI).
The study will examine the relationships between MS severity and caregiver health outcomes within the framework of the International Classification of Functioning, Disability and Health (ICF). No therapeutic intervention will be administered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregivers of Patients With Multiple Sclerosis | – | –Adult caregivers who have provided regular care to a person diagnosed with multiple sclerosis for at least six months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of 68 adult caregivers of individuals diagnosed with multiple sclerosis who receive care at Başkent University Hospital. Caregivers will be recruited to evaluate the associations between MS severity and caregiver health outcomes.
Key inclusion criteria (3 listed)
- Being 18 years of age or older.
- Providing regular care to an individual diagnosed with multiple sclerosis for at least six months.
- Volunteering to participate in the study.
Key exclusion criteria (3 listed)
- Having a cognitive impairment that prevents completion of the assessments.
- Having a severe physical or psychiatric condition that may interfere with study assessments.
- Being unable to complete the questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Caregiver Burden (Zarit Burden Interview)
Time frame: Baseline
Caregiver burden will be assessed using the Zarit Burden Interview (ZBI). Higher scores indicate greater perceived caregiver burden.
4 secondary outcomes
Sleep Quality (Pittsburgh Sleep Quality Index)
Time frame: Baseline
Physical Activity (IPAQ-SF)
Time frame: Baseline
Body Awareness (Body Awareness Questionnaire)
Time frame: Baseline
Perceived Stress (Perceived Stress Scale)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 17653999Khan F, Pallant J, Brand C. Caregiver strain and factors associated with caregiver self-efficacy and quality of life in a community cohort with multiple sclerosis. Disabil Rehabil. 2007 Aug 30;29(16):1241-50. doi: 10.1080/01443610600964141.
- Background: PubMed 32444986Maguire R, Maguire P. Caregiver Burden in Multiple Sclerosis: Recent Trends and Future Directions. Curr Neurol Neurosci Rep. 2020 May 22;20(7):18. doi: 10.1007/s11910-020-01043-5.
- Individual participant dataSharing planned: No
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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.
Büşra S Korkusuz study chair
Ankara University
Cemre Yılmaz study chair
Atılım University
Süleyman Korkusuz principal investigator
Atılım University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Caregiver Burden, run by Süleyman Korkusuz 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 3 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: opening soon, as of the sponsor's last update on 8 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Süleyman Korkusuz, PhD (+905388675480, suleyman.korkusuz@atilim.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Burden (Zarit Burden Interview) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07842744, which also lists 2 linked publications.
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 8 Oct 2026.