Myasthenia GravisNCT03826056
Neurology Inpatient Clinical Education Trial
A study testing Current standard discharge educational intervention and Personalized discharge educational intervention in people with Myasthenia Gravis and Guillain-Barre Syndrome, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The objective of this study is to compare the effectiveness of a personalized patient education program to the current hospital education and evaluate its impact using patient satisfaction scores. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Myasthenia Gravis, Guillain-Barre Syndrome, Multiple Sclerosis
- What is being tested?
- Current standard discharge educational intervention and Personalized discharge educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 7 Dec 2021
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 18
- Must have the capacity to consent and understand the study related activities and education materials.
Who cannot join
- Under the age of 18
- Have a condition that impairs the ability to understand the study, its risks, and appropriately consent for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth- Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
The objective of this study is to compare the effectiveness of a personalized patient education program to the current hospital education and evaluate its impact using patient satisfaction scores.
The investigators hypothesize that a personalized patient education intervention will increase patient's understanding of their diagnosis and satisfaction with the care as reflected in the survey results.
- Conditions
- Myasthenia Gravis, Guillain-Barre Syndrome, Multiple Sclerosis, Seizures, Parkinsonism, Meningitis
- Being tested
- Current standard discharge educational intervention, Personalized discharge educational intervention
- Keywords
- clinical education
- Medical subject headings
- Myasthenia Gravis, Guillain-Barre Syndrome, Multiple Sclerosis, Seizures, Parkinsonian Disorders, Meningitis, Encephalitis, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current standard discharge educational interventionBehavioural
The patients will receive the current hospital standard discharge educational material which explains the diagnosis, new medications, follow up and any activity/diet restrictions. A member of the study team will explain this material to the patient and answer any questions.
Personalized discharge educational interventionBehavioural
The patients will receive a new personalized discharge educational material which will explain the specifics of their disorder, the treatment, and prognosis. The materials will contain simple, organized explanations and graphics. A member of the study team will explain this material to the patient and answer any questions.
| Study group | Role | What they receive |
|---|---|---|
| Current standard education group | Active comparator | A study team member will use the current hospital standard educational material to explain the discharge diagnosis to the patient, the treatment, and the follow up needed. The study team member will also give a survey with a preaddressed envelope to each participant to complete at his or her convenience. Receives: Behavioral: Current standard discharge educational intervention |
| New personalized education group | Experimental | A study team member will use the new personalized educational materials to explain the discharge diagnosis to the patient, the treatment, and the follow up needed. The study team member will also give a survey with a preaddressed envelope to each participant to complete at his or her convenience. Receives: Behavioral: Personalized discharge educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction scores
The patients will answer a survey consisting of seven multiple-choice questions regarding their perception of the education intervention. Each questions will be scored on a scale of one to four for a total possible score of 28 for all 7 questions. A score of 1 indicates a negative perception of the education whereas 4 indicates the most positive impression. Therefore the lowest possible score is 7 for a severely negative perception of the education and the highest score is 28 for a very positive impression of the education program. Only the total scores will be compared for statistical analysis. Scores from patients in the current standard and new personalized education intervention groups will be compared.
Measured: Subjects will be expected to mail the feedback forms within 2 weeks of discharge. Investigators will mail a single reminder prepaid return mail with a copy of the questionnaire to patients who do not respond within this time allowing 1 month total time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start1 Feb 2019
- Primary completion7 Dec 2021
- Study completion7 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study team members will randomize patients to receive either the current standard hospital education material or the new personalized education material. Investigators will use a stratified randomization process to allocate the patients from different categories including age range, gender, and discharge diagnosis into each group. Thereby the investigators will achieve equal distribution of diagnoses and other demographics among groups in real time. They will review the two groups when performing statistical analysis near the end of the study to ensure heterogeneity of distribution. A study team member who has also been a member of the care team will use the either the current hospital standard or the new personalized education materials to explain the discharge diagnosis to the patient, the treatment, and the follow up needed. The study team member will also give a survey with a preaddressed envelope to each participant to complete at his or her convenience.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vijay Renga, Dartmouth-Hitchcock Medical Center
- Investigators
- Vijay Renga, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826056
- Sponsor's protocol ID
- D19046
- Status last verified
- Jan 2021
- First submitted
- 30 Jan 2019
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Investigators will protect patients' identity by using identification numbers that do not correspond to any personal identification information. They will enter the survey results to the institution's safely encrypted database.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurology Inpatient Clinical Education Trial
- ClinicalTrials.gov ID
- NCT03826056
- Acronym / sponsor ID
- D19046
- Conditions
- Myasthenia Gravis, Guillain-Barre Syndrome, Multiple Sclerosis, Seizures, Parkinsonism, Meningitis
- Keywords
- clinical education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 1 Feb 2019 (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 objective of this study is to compare the effectiveness of a personalized patient education program to the current hospital education and evaluate its impact using patient satisfaction scores.
The investigators hypothesize that a personalized patient education intervention will increase patient's understanding of their diagnosis and satisfaction with the care as reflected in the survey results.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Study team members will randomize patients to receive either the current standard hospital education material or the new personalized education material. Investigators will use a stratified randomization process to allocate the patients from different categories including age range, gender, and discharge diagnosis into each group. Thereby the investigators will achieve equal distribution of diagnoses and other demographics among groups in real time. They will review the two groups when performing statistical analysis near the end of the study to ensure heterogeneity of distribution. A study team member who has also been a member of the care team will use the either the current hospital standard or the new personalized education materials to explain the discharge diagnosis to the patient, the treatment, and the follow up needed. The study team member will also give a survey with a preaddressed envelope to each participant to complete at his or her convenience.
| Arm | Type | Receives |
|---|---|---|
| Current standard education group | Active comparator | Behavioral: Current standard discharge educational interventionA study team member will use the current hospital standard educational material to explain the discharge diagnosis to the patient, the treatment, and the follow up needed. The study team member will also give a survey with a preaddressed envelope to each participant to complete at his or her convenience. |
| New personalized education group | Experimental | Behavioral: Personalized discharge educational interventionA study team member will use the new personalized educational materials to explain the discharge diagnosis to the patient, the treatment, and the follow up needed. The study team member will also give a survey with a preaddressed envelope to each participant to complete at his or her convenience. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over the age of 18
- Must have the capacity to consent and understand the study related activities and education materials.
Key exclusion criteria (2 listed)
- Under the age of 18
- Have a condition that impairs the ability to understand the study, its risks, and appropriately consent for the study
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 |
|---|---|---|
| Current standard discharge educational interventionThe patients will receive the current hospital standard discharge educational material which explains the diagnosis, new medications, follow up and any activity/diet restrictions. A member of the study team will explain this material to the patient and answer any questions. | Behavioural | Current standard education group |
| Personalized discharge educational interventionThe patients will receive a new personalized discharge educational material which will explain the specifics of their disorder, the treatment, and prognosis. The materials will contain simple, organized explanations and graphics. A member of the study team will explain this material to the patient and answer any questions. | Behavioural | New personalized education group |
Primary outcome
Patient satisfaction scores
Time frame: Subjects will be expected to mail the feedback forms within 2 weeks of discharge. Investigators will mail a single reminder prepaid return mail with a copy of the questionnaire to patients who do not respond within this time allowing 1 month total time.
The patients will answer a survey consisting of seven multiple-choice questions regarding their perception of the education intervention. Each questions will be scored on a scale of one to four for a total possible score of 28 for all 7 questions. A score of 1 indicates a negative perception of the education whereas 4 indicates the most positive impression. Therefore the lowest possible score is 7 for a severely negative perception of the education and the highest score is 28 for a very positive impression of the education program. Only the total scores will be compared for statistical analysis. Scores from patients in the current standard and new personalized education intervention groups will be compared.
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 11 Jan 2022.
- Individual participant dataSharing planned: No. Investigators will protect patients' identity by using identification numbers that do not correspond to any personal identification information. They will enter the survey results to the institution's safely encrypted database.
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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.
Vijay Renga, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Current standard discharge educational intervention and Personalized discharge educational intervention in people with Myasthenia Gravis and Guillain-Barre Syndrome, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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: finished, as of the sponsor's last update on 11 Jan 2022. 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 United States. 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?
Patient satisfaction scores (time frame: Subjects will be expected to mail the feedback forms within 2 weeks of discharge. Investigators will mail a single reminder prepaid return mail with a copy of the questionnaire to patients who do not respond within this time allowing 1 month total time.). 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 11 Jan 2022.