| CTRI Number |
CTRI/2022/10/046427 [Registered on: 12/10/2022] Trial Registered Prospectively |
| Last Modified On: |
08/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Other (Specify) [Patient education] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of pharmaceutical care in schizophrenic patients |
|
Scientific Title of Study
|
A prospective study to assess the impact of pharmacist-led patient-centered interventions in schizophrenia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak C G |
| Designation |
PhD Research scholar |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of pharmaceutical sciences,
Nitte (Deemed to be University), Paneer, Deralakatte, Manguluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9606136133 |
| Fax |
|
| Email |
cgdeepak869@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrinivasa Bhat U |
| Designation |
Professor and Head |
| Affiliation |
KS Hegde medical Academy |
| Address |
Department of Psychiatry,
KS Hegde Medical Academy,
Nitte (Deemed to be University) Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845204136 |
| Fax |
|
| Email |
shrinivasabhat@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Juno J Joel |
| Designation |
Assistant Professor and Head |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Paneer, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9480470727 |
| Fax |
|
| Email |
junojoel@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Self/ Justice KS Charitable Hospital, Deralakatte, Karnataka-575018 |
|
|
Primary Sponsor
|
| Name |
Dr Deepak C G |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Paneer, Deralakatte, Mangaluru, Dakshinna Kannada, Karnataka, 575018 |
| Type of Sponsor |
Other [Funded by investigator itself] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepak C G |
Justice K.S Hegde Charitable Hospital |
Department of psychiatry,
Justice K S Hegde Charitable Hospital, Deralakatte, Mangaluru, 575018
Dakshina Kannada
KARNATAKA |
9606136133
cgdeepak869@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee, Nitte (Deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F209||Schizophrenia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
The consist of schizophrenic patients. They will receive only the usual standard care as per guidelines from the psychiatrist and nurses.
Each patient is required to be monitored for 4 times i.e. baseline, 4th , 8th and 12th month after enrolling the study. The number of revisits to the hospital during the study period will be monitored to assess the economic burden. |
| Intervention |
Interventional trial- Randomized controlled trial |
The study consists of schizophrenic patients. Each patient is required to be monitored for 4 times i.e. baseline, 4th , 8th and 12th month after enrolling the study. They will receive pharmaceutical care along with standard care delivered by the Principal investigator. The pharmaceutical care consists of education through validated leaflet, continuous monitoring and evaluating their physical activity using Simple physical activity questionnaire (SIMPAQ), medication adherence using Morisky Green-Levine (MGL) adherence scale, analyzing their health related quality of life using WHO quality of Life-Abbreviated form questionnaire (WHOQOL-BREF) and economic analysis using cost of illness study.
The education is provided to the patient or caretaker during the baseline visit with the help of patient information leaflet which contains information about the disease, drugs and lifestyle modification.
This group will be monitored and assessed during the study period by reminding them twice/thrice a week to ensure whether they comply with the instructions regarding lifestyle modification and medication adherence.
The number of revisits to the hospital other than the follow-up visit during the study period will be monitored to assess the economic burden. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient or caretaker
Patient or caretaker willing to provide informed consent
Patients aged ≥ 18 and ≤ 65 years old
Patients diagnosed with schizophrenia and schizophrenia spectrum disorders who were on the treatment of antipsychotic drugs with or without co-morbidities of hypertension, diabetes, hypercholesterolemia and weight gain
Both genders |
|
| ExclusionCriteria |
| Details |
Patient or caretaker unwilling to provide consent
Patients with other severe chronic medical conditions, including cancer, end-stage renal disease, heart failure and HIV
Patients with a diagnosis of Cushing syndrome, hypothyroidism, eating disorder
Patients who are engaged in the weight management programs within the past 3 months
Patients who are taking other forms of medicines to control weight including Ayurvedha, Homeopathy
Patients with co-existing physical illnesses that reduce their ability to participate in the study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Impact of pharmaceutical care in improvement or prevention cardiometabolic diseases in schizophrenia by controlling weight gain & obesity will be studied |
0 4 8 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes: Measurement of medication adherence, quality of life and comparing the economic burden of schizophrenic patients by cost of illness study |
0 4 8 12 months |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/10/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Schizophrenia is a serious mental disorder of unknown origin. This complex disorder requires lifelong therapy with antipsychotics. The long-term therapy of antipsychotics and an unhealthy lifestyle enhance the risk of cardiometabolic diseases like hypertension, diabetes and dyslipidemia, weight gain and obesity, resulting in poor quality of life. Weight gain and obesity are two critical issues in schizophrenia. Both factors can unfavourably affect the schizophrenic patient by increasing the risk of cardiometabolic diseases. An estimated 60% of schizophrenic patients stop taking medications after 2-3 months and 80% in 2 years. The non-adherence rate of schizophrenia is estimated at 60-70%. This reduces the quality of life and proportionally elevates the economic burden on schizophrenia patients. Hence, the study’s primary purpose is to assess the impact of pharmaceutical care on schizophrenia. The proposed study aims to test the hypothesis of whether pharmacist interventions yield better outcomes on schizophrenia patients.
|