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Validation and Assessment of Patient Adherence to Opioids for Cancer Pain Using MMAS 8 Pain Clinic

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ClinicalTrials.gov Identifier: NCT02804477
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Parmanand Jain, Tata Memorial Centre

Brief Summary:
This study aims at finding degree of adherence of patients to their chronic pain medication prescriptions containing opioid e.g. Morphine, using Morisky Medication Adherence Scale 8, self- reported questionnaire. Also relationship of various demographic, disease related and opioid related factors to medication adherence.

Condition or disease
Chronic Cancer Pain

Detailed Description:
After institutional review board approval, a Pilot study including 30 patients will be conducted to validate Morisky Medication Adherence Scale 8 to validate the questionnaire for cross cultural variation. The data collected will be analyzed and result will be submitted to institutional review board for approval to conduct the parent study. Following the above approval, all adult patients , more than 18 yrs. of age, who are on a strong opioid for their chronic cancer pain, taken prescription from pain clinic at least once in past, who are able to understand and communicate Hindi will be invited to participate in the study. Each patient will be verbally asked about their medication and same will be confirmed by their previous medical records. An informed written consent will be obtained. Data will be collected by PI or co-investigator after obtaining written consent at Pain clinic(general and private) of Tata Memorial Hospital. Fund for purchasing the copyright to use the Hindi translation of Morisky Medication Adherence Scale 8, was provided by the department of Anesthesia Account, Tata Memorial Hospital, after due permission obtained from, Director Tata Memorial Center and Head of the department of Anesthesiology, critical care and pain, Tata Memorial Center. The precise scoring and permission to use the Hindi translation of the scale has been obtained from the developer. For income we will be considering private and general category of the patients respectively.Data will be analyzed using International Business machines software package for statistical analysis version 20.0.Pilot study data will be analyzed applying tests as internal consistency (Cronbach's alfa), Test retest variability and factor analysis.For parent study in the uni-variate analysis all variables listed above will consecutively tested for significant associations with ''good adherence'' as the outcome variable. Chi-square tests and Student's t-tests will used for categorical and continuous variables, respectively. All variables will be unconditionally entered into a binary logistic multi variate analysis. All p values #0.05 will regarded as statistically significant.

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Study Type : Observational
Actual Enrollment : 330 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Validation and Assessment of Patient Adherence to Opioids for Cancer Pain Using MMAS 8 Questionnaire in Pain Clinic
Actual Study Start Date : June 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : January 2017



Primary Outcome Measures :
  1. validation and assessment of adherence to opioids for chronic cancer pain in pain clinic using Morisky medication adherence scale 8 [ Time Frame: six months ]
    to do a pilot study comprising of 30 patients for cross cultural validation of Morisky medication adherence questionnaire , if it gets validated then assessment of adherence of patients suffering from chronic cancer pain to opioids.


Secondary Outcome Measures :
  1. relationship of adherence to opioids with demographic characteristics [ Time Frame: six months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients visiting to pain clinic( private and general) will be screened and enrolled according to inclusion and exclusion criteria
Criteria

Inclusion Criteria:

  1. All adult patients > 18 yrs. of age
  2. Patients suffering from chronic pain of any type and severity 3. On opioid i.e. Morphine, taken prescription at least once 4. Who can understand and communicate Hindi

Exclusion Criteria:

  1. Refusal of consent
  2. Paediatric patients
  3. Patients who cannot understand or communicate Hindi

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804477


Locations
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India
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400094
Sponsors and Collaborators
Tata Memorial Centre
Investigators
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Principal Investigator: Parmanand Jain, MD Professor
Study Chair: charushree E jibhkate, Junior resident Junior resident

Publications:
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Responsible Party: Parmanand Jain, Professor, Tata Memorial Centre
ClinicalTrials.gov Identifier: NCT02804477     History of Changes
Other Study ID Numbers: TataMC 1680
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Parmanand Jain, Tata Memorial Centre:
adherence
opioid
MMAS 8, morisky medication adherence scale
validation

Additional relevant MeSH terms:
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Cancer Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents