EpilepsyNCT02547389
Enhancing Medical Compliance and Health-related Quality of Life of Patients With Epilepsy
A study testing Community support group and Printed material Supported in people with Epilepsy, run by NMP Medical Research Institute.
Trial summary
Improving medical compliance and health-related quality of life (HRQoL) among people with epilepsy (PWE) has become the focus of various treatment programs and behavioral interventions which continue to be challenging to both patients and health care professionals. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Community support group and Printed material Supported
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jun 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Eligible participants must have a definitive diagnosis of epilepsy for at least 6 months, based on the clinical judgement of the investigators. Epilepsy is defined by two or more unprovoked seizures. Clinical history, electroencephalography, and imaging data are all instrumental in rendering a formal decision. The seizure type, frequency, or severity are not criteria for exclusion, although this information will be recorded.
- Patients must have a seizure frequency of at least two seizures in a 6 month period of time.
- Patients must be on at least one anti-epileptic medication.
- Patients must be able to report seizure frequency with either a paper or electronic diary.
- Patients must be able to read and understand either English or Hindi.
- Patients must be able to complete questionnaires and provide informed consent to this study.
Who cannot join
- A diagnosis of psychogenic nonepileptic seizures
- Severe depression, anxiety, or psychosis
- Recent problem with substance abuse.
About this study
Official title: Enhancing Medical Compliance and Health-related Quality of Life of Patients With Epilepsy: Randomized Controlled Trial
Improving medical compliance and health-related quality of life (HRQoL) among people with epilepsy (PWE) has become the focus of various treatment programs and behavioral interventions which continue to be challenging to both patients and health care professionals.
In order to design an effective intervention on the management of epilepsy, the drug management of epilepsy by community health workers was evaluated.
- Conditions
- Epilepsy
- Being tested
- Community support group, Printed material Supported
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community support groupBehavioural
Printed material SupportedOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (IG) | Active comparator | IG additionally received community health programs with health workers(intensive education, consultation services, maintenance of anepilepsy tracking card, and repeated reminders). Receives: Behavioral: Community support group |
| Control Group (CG) | Other | Patients in the CG were supplied with only printed epilepsy educational module Receives: Other: Printed material Supported |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with taking prescribed medications
Assessment of compliance with taking medications at regularly scheduled intervals
Measured: 12 months
Secondary outcomes (2)
Seizure frequency per month
Assessment of seizure count accuracy by assessing total number of seizures reported per month
Measured: change from baseline to 12 months in number of seizures per month assessed by patients diary
Quality of Life (Malay Quality of Life in Epilepsy Inventory-30)
Malay Quality of Life in Epilepsy Inventory-30, to assess for overall change in quality of life measures
Measured: change from baseline to 12 months in quality of life assessed by Malay Quality of Life in Epilepsy Inventory-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startJan 2014
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Macmillan Research Group UK
- Responsible party
- Sponsor
- Investigators
- Hitesh K Nayak, Principal investigator, NMP Medical Research InstituteNeha Sharma, PhD, Study director, Macmillan Research Group UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547389
- Sponsor's protocol ID
- nmp/22181
- Status last verified
- Sep 2015
- First submitted
- 2 Sep 2015
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Medical Compliance and Health-related Quality of Life of Patients With Epilepsy: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02547389
- Acronym / sponsor ID
- nmp/22181
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Macmillan Research Group UK
- Study start
- Jan 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Sep 2015 (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.
Improving medical compliance and health-related quality of life (HRQoL) among people with epilepsy (PWE) has become the focus of various treatment programs and behavioral interventions which continue to be challenging to both patients and health care professionals.
In order to design an effective intervention on the management of epilepsy, the drug management of epilepsy by community health workers was evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (IG) | Active comparator | Behavioral: Community support groupIG additionally received community health programs with health workers(intensive education, consultation services, maintenance of anepilepsy tracking card, and repeated reminders). |
| Control Group (CG) | Other | Other: Printed material SupportedPatients in the CG were supplied with only printed epilepsy educational module |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Eligible participants must have a definitive diagnosis of epilepsy for at least 6 months, based on the clinical judgement of the investigators. Epilepsy is defined by two or more unprovoked seizures. Clinical history, electroencephalography, and imaging data are all instrumental in rendering a formal decision. The seizure type, frequency, or severity are not criteria for exclusion, although this information will be recorded.
- Patients must have a seizure frequency of at least two seizures in a 6 month period of time.
- Patients must be on at least one anti-epileptic medication.
- Patients must be able to report seizure frequency with either a paper or electronic diary.
- Patients must be able to read and understand either English or Hindi.
Key exclusion criteria (3 listed)
- A diagnosis of psychogenic nonepileptic seizures
- Severe depression, anxiety, or psychosis
- Recent problem with substance abuse.
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 |
|---|---|---|
| Community support group | Behavioural | Intervention Group (IG) |
| Printed material Supported | Other | Control Group (CG) |
Primary outcome
Compliance with taking prescribed medications
Time frame: 12 months
Assessment of compliance with taking medications at regularly scheduled intervals
2 secondary outcomes
Seizure frequency per month
Time frame: change from baseline to 12 months in number of seizures per month assessed by patients diary
Quality of Life (Malay Quality of Life in Epilepsy Inventory-30)
Time frame: change from baseline to 12 months in quality of life assessed by Malay Quality of Life in Epilepsy Inventory-30
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 Sep 2015.
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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.
Hitesh K Nayak principal investigator
NMP Medical Research Institute
Neha Sharma, PhD study director
Macmillan Research Group UK
Questions about this trial
What is this clinical trial studying?
A study testing Community support group and Printed material Supported in people with Epilepsy, run by NMP Medical Research Institute.
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 6 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: finished, as of the sponsor's last update on 11 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Compliance with taking prescribed medications (time frame: 12 months). 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 Sep 2015.