EpilepsyCOGNIPHARM-INCT06034353
Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients
A study testing Pharmacist-led Cognitive Behavioral therapy in people with Epilepsy, run by Hamdard University at 1 site in Pakistan.
Trial summary
The purpose of this interventional study is to assess the impact of pharmacist-led cognitive behavioral intervention in epileptic patients. The main questions are: 1. If pharmacist-led cognitive behavioral therapy can help in improving patient medication adherence? 2. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Pharmacist-led Cognitive Behavioral therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Sep 2023to 15 Jul 2024
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with confirmed diagnosis.
- Patients treated for epilepsy with at least one anti epileptic drug, subjects willing to participate in the study with or without other severe co-morbidities were included in the study.
Who cannot join
- Pregnant female patients.
- Patients who provide incomplete information
- Patients with any terminal disease e.g., end stage renal disease
- Patients not willing to participate were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this interventional study is to assess the impact of pharmacist-led cognitive behavioral intervention in epileptic patients. The main questions are:
- If pharmacist-led cognitive behavioral therapy can help in improving patient medication adherence?
- How will the cognitive behavioral therapy impact the quality of life of the patients?
Participants of this study will be provided basic or advanced level counselling and educational material as part of their routine pharmacy visit.
Researchers will compare the two groups (Basic and advanced) to see which of the two groups are better in term of medication adherence and quality of life.
Read the detailed description
The purpose of the study is to investigate whether incorporation of pharmacist-led cognitive behavioral therapy (CBT) to the treatment of epileptic patients can result in better adherence to anti epileptic drugs. In order to manage epilepsy effectively, medication adherence is essential. Missed doses or irregular drug use can increase the frequency of seizures and reduce the effectiveness of treatment. In order to improve medicine adherence rates, the study will examine if cognitive behavioral therapy (CBT) therapies can have a favorable effect on patients' motivation, coping techniques, Medication beliefs, reduction in adverse drug reaction (ADRs), Seizures frequency and medication related problems (MRPs) other than adverse drug reaction (ADRs) and overall quality of life of epileptic patients.
- Conditions
- Epilepsy
- Being tested
- Pharmacist-led Cognitive Behavioral therapy
- Keywords
- Cognitive behavioral therapy, Pharmacist, Medication Adherence, Quality of life
- Medical subject headings
- Epilepsy, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-led Cognitive Behavioral therapyBehavioural
Pharmacist-led Cognitive Behavioral therapy is patient centered approach that focus both physical and emotional aspect of health is provided. It is focused to identify negative and change negative thought pattern and behavior to improve mental and physical well being.Incorporation education about healthy meal choices, relaxation techniques, self management strategies,to improve education about potential adverse effect, how to recognize and on followup calls how to adjust medication doses along with this is provided.
| Study group | Role | What they receive |
|---|---|---|
| Basic group | Active comparator | Lifestyle Modifications: General education about healthy life style and diet. Education : general awareness about disease and medication Pill Planner: Pill planner will be provided to keep them adherent to their medication Counselling: Counsel the patients about there medication dosage, frequency and appropriate time. Receives: Behavioral: Pharmacist-led Cognitive Behavioral therapy |
| Advanced | Experimental | Lifestyle Modifications: Specific education on keto-diet, yoga and meditation Education : Specific disease education targeting medication adverse drug reaction (ADR), seizure chart management Pill Planner: Pill planner will also be provided to this group Counselling: Cognitive Behavioral therapy will be provided Receives: Behavioral: Pharmacist-led Cognitive Behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
Adherence will be assessed using (Medication Adherence Reporting Scale) MARS-10.
This scale describes three-dimension, Medication adherence behavior (1-4), attitude towards taking medication (5-8), negative side effects and attitudes to psychotropic medication (9-10). Each question has Yes and No response, a response consistent with adherence is coded as 1 and with non-adherence coded as 0. Higher the score higher will be the adherence. Adherence <6 is poor adherence, and >8 is high adherence.
Measured: 3 months
Quality of life of Epileptic patients
Patient's quality of life will be assessed using Quality of life for epilepsy scale(QOLIE-31). QOLIE-31(Quality of life in epilepsy) used for quality-of-life assessment which assess the patient's life's quality level along using anti-epileptic drug (AED) therapy through close ended questions with a score. The score can range from 0-100, with 100 representing the best quality of life.
Measured: 3 months
Secondary outcomes (3)
Incidence of Drug-Drug Interactions
Drug interactions among epileptic and non-epileptic drug will be assessed using standard website (update-Lexicomp) It is used to access the reduction in no. of drug drug interaction after pharmacist intervation in both basic and advance groups.
Measured: 3 months
Incidence of Adverse reactions
Adverse reactions of all anti-epileptic drug will be noted while assessing a patient.
It is used to access the reduction in frequency of Adverse drug reaction after pharmacist intervation in both basic and advance groups.
Measured: 3 months
Rate of seizures per week
While assessing patient no. of seizures per week is asked and noted by the pharmacist. After intervening both basic and advance group impact of intervation is accessed for no. of seizures in the groups.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start22 Sep 2023
- Primary completion20 May 2024
- Study completion15 Jul 2024
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
- Participant
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamdard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matti Ullah, Hamdard University
- Investigators
- Matti Ullah, PhD, Study director, Hamdard University Islamabad CampusIqra Farooq, MPhil, Principal investigator, Shifa International HospitalMuhammad Shafiq, BS. (Hons.), Study chair, Subhan Medical TrustEmmama Jamil, MPhil, Study chair, Hamdard University Islamabad Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034353
- Sponsor's protocol ID
- NA0823
- Acronym
- COGNIPHARM-I
- Status last verified
- Jan 2025
- First submitted
- 2 Sep 2023
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing patient data will depend on the patient's consent. If the patient doesn't allow to share data with others, we will not be able to share individual data.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients
- ClinicalTrials.gov ID
- NCT06034353
- Acronym / sponsor ID
- COGNIPHARM-I / NA0823
- Conditions
- Epilepsy
- Keywords
- Cognitive behavioral therapy, Pharmacist, Medication Adherence, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Hamdard UniversityUniversity, hospital or other
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 13 Sep 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 purpose of this interventional study is to assess the impact of pharmacist-led cognitive behavioral intervention in epileptic patients. The main questions are:
- If pharmacist-led cognitive behavioral therapy can help in improving patient medication adherence?
- How will the cognitive behavioral therapy impact the quality of life of the patients?
Participants of this study will be provided basic or advanced level counselling and educational material as part of their routine pharmacy visit.
Researchers will compare the two groups (Basic and advanced) to see which of the two groups are better in term of medication adherence and quality of life.
Detailed description
The purpose of the study is to investigate whether incorporation of pharmacist-led cognitive behavioral therapy (CBT) to the treatment of epileptic patients can result in better adherence to anti epileptic drugs. In order to manage epilepsy effectively, medication adherence is essential. Missed doses or irregular drug use can increase the frequency of seizures and reduce the effectiveness of treatment. In order to improve medicine adherence rates, the study will examine if cognitive behavioral therapy (CBT) therapies can have a favorable effect on patients' motivation, coping techniques, Medication beliefs, reduction in adverse drug reaction (ADRs), Seizures frequency and medication related problems (MRPs) other than adverse drug reaction (ADRs) and overall quality of life of epileptic patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basic group | Active comparator | Behavioral: Pharmacist-led Cognitive Behavioral therapyLifestyle Modifications: General education about healthy life style and diet. Education : general awareness about disease and medication Pill Planner: Pill planner will be provided to keep them adherent to their medication Counselling: Counsel the patients about there medication dosage, frequency and appropriate time. |
| Advanced | Experimental | Behavioral: Pharmacist-led Cognitive Behavioral therapyLifestyle Modifications: Specific education on keto-diet, yoga and meditation Education : Specific disease education targeting medication adverse drug reaction (ADR), seizure chart management Pill Planner: Pill planner will also be provided to this group Counselling: Cognitive Behavioral therapy will be provided |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with confirmed diagnosis.
- Patients treated for epilepsy with at least one anti epileptic drug, subjects willing to participate in the study with or without other severe co-morbidities were included in the study.
Key exclusion criteria (4 listed)
- Pregnant female patients.
- Patients who provide incomplete information
- Patients with any terminal disease e.g., end stage renal disease
- Patients not willing to participate were excluded from 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 |
|---|---|---|
| Pharmacist-led Cognitive Behavioral therapyPharmacist-led Cognitive Behavioral therapy is patient centered approach that focus both physical and emotional aspect of health is provided. It is focused to identify negative and change negative thought pattern and behavior to improve mental and physical well being.Incorporation education about healthy meal choices, relaxation techniques, self management strategies,to improve education about potential adverse effect, how to recognize and on followup calls how to adjust medication doses along with this is provided. | Behavioural | Advanced, Basic group |
Primary outcome
Medication adherence
Time frame: 3 months
Adherence will be assessed using (Medication Adherence Reporting Scale) MARS-10. This scale describes three-dimension, Medication adherence behavior (1-4), attitude towards taking medication (5-8), negative side effects and attitudes to psychotropic medication (9-10). Each question has Yes and No response, a response consistent with adherence is coded as 1 and with non-adherence coded as 0. Higher the score higher will be the adherence. Adherence <6 is poor adherence, and >8 is high adherence.
Quality of life of Epileptic patients
Time frame: 3 months
Patient's quality of life will be assessed using Quality of life for epilepsy scale(QOLIE-31). QOLIE-31(Quality of life in epilepsy) used for quality-of-life assessment which assess the patient's life's quality level along using anti-epileptic drug (AED) therapy through close ended questions with a score. The score can range from 0-100, with 100 representing the best quality of life.
3 secondary outcomes
Incidence of Drug-Drug Interactions
Time frame: 3 months
Incidence of Adverse reactions
Time frame: 3 months
Rate of seizures per week
Time frame: 3 months
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 31 Jan 2025.
- Individual participant dataSharing planned: Undecided. Sharing patient data will depend on the patient's consent. If the patient doesn't allow to share data with others, we will not be able to share individual data.
Related trials for Epilepsy
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Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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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.
Matti Ullah, PhD study director
Hamdard University Islamabad Campus
Iqra Farooq, MPhil principal investigator
Shifa International Hospital
Muhammad Shafiq, BS. (Hons.) study chair
Subhan Medical Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-led Cognitive Behavioral therapy in people with Epilepsy, run by Hamdard University at 1 site in Pakistan.
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 4 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 31 Jan 2025. 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 Pakistan. 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?
Medication adherence (time frame: 3 months). The study lists 2 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 31 Jan 2025.