Multiple SclerosisNCT02760082
Motivation of Patients Diagnosed With Multiple Sclerosis to Become Citizen Researchers
An observational study of Multiple Sclerosis, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The study will based on qualitative methods investigate motivational factors among patients diagnosed with multiple sclerosis for registering nutrition, environmental factors, stress provoking factors and physical activity (NESPA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Qualitative evaluation
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2016to Apr 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with Multiple Sclerosis
Who may be able to join
- Age 18 or above
- Read, write and understand Danish
Who cannot join
- Aphasia
- Severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
Astrid K Knudsen, PhD Student contact
Lars Kayser, PhD, MD contact
About this study
Official title: Identifying Motivational Factors for Registering Nutrition and Lifestyle Factors Among Patients With Multiple Sclerosis
The study will based on qualitative methods investigate motivational factors among patients diagnosed with multiple sclerosis for registering nutrition, environmental factors, stress provoking factors and physical activity (NESPA). The aim is to gain knowledge on motivational factors for using a digital tool for collecting data on NESPA and incorporate this knowledge into a form which can be used in requirement specifications for such a digital tool.
- Conditions
- Multiple Sclerosis
- Being tested
- Qualitative evaluation
- Keywords
- Multiple Sclerosis, Qualitative study, Motivation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative evaluationOther
| Study group | Role | What they receive |
|---|---|---|
| Semi-structured interviews | 20 participants (anticipated) Receives: Other: Qualitative evaluation | |
| Questionnaire survey | 400 respondents (anticipated) Receives: Other: Qualitative evaluation | |
| Focus group interviews | 3-5 focus group interviews (anticipated) Receives: Other: Qualitative evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of qualitative interviews and measurement of eHealth literacy (eHealth literacy questionnaire)
Measured: Up to 6 months
Evaluation of motivational factors based on questionnaire survey
Measured: Up to 10 months
Analysis of focus group interviews on motivational factors for registering nutrition and lifestyle factors among patients with multiple sclerosis
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Observational
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Multiple Sclerosis Society
- Responsible party
- Principal investigator, Astrid Knudsen, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760082
- Sponsor's protocol ID
- 12016SCL
- Status last verified
- Apr 2016
- First submitted
- 28 Apr 2016
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Motivational Factors for Registering Nutrition and Lifestyle Factors Among Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02760082
- Acronym / sponsor ID
- 12016SCL
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Qualitative study, Motivation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Danish Multiple Sclerosis Society
- Study start
- Feb 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 3 May 2016 (estimated)
- 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 study will based on qualitative methods investigate motivational factors among patients diagnosed with multiple sclerosis for registering nutrition, environmental factors, stress provoking factors and physical activity (NESPA). The aim is to gain knowledge on motivational factors for using a digital tool for collecting data on NESPA and incorporate this knowledge into a form which can be used in requirement specifications for such a digital tool.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Semi-structured interviews | – | Other: Qualitative evaluation20 participants (anticipated) |
| Questionnaire survey | – | Other: Qualitative evaluation400 respondents (anticipated) |
| Focus group interviews | – | Other: Qualitative evaluation3-5 focus group interviews (anticipated) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Multiple Sclerosis
Key inclusion criteria (2 listed)
- Age 18 or above
- Read, write and understand Danish
Key exclusion criteria (2 listed)
- Aphasia
- Severe cognitive impairment
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 |
|---|---|---|
| Qualitative evaluation | Other | Focus group interviews, Questionnaire survey, Semi-structured interviews |
Primary outcome
Analysis of qualitative interviews and measurement of eHealth literacy (eHealth literacy questionnaire)
Time frame: Up to 6 months
Evaluation of motivational factors based on questionnaire survey
Time frame: Up to 10 months
Analysis of focus group interviews on motivational factors for registering nutrition and lifestyle factors among patients with multiple sclerosis
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
- 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. This study is not recruiting at the moment.
Astrid K Knudsen, PhD Student contact
Lars Kayser, PhD, MD contact
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, run by University of Copenhagen at 1 site in Denmark.
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 2 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: status not confirmed, as of the sponsor's last update on 3 May 2016. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Astrid K Knudsen, PhD Student (askn@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of qualitative interviews and measurement of eHealth literacy (eHealth literacy questionnaire) (time frame: Up to 6 months). The study lists 3 primary outcomes in all. 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 3 May 2016.