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

NCT ID: NCT02804477

Last Updated: 2017-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Cancer Pain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tata Memorial Centre

OTHER

Sponsor Role lead

Responsible Party

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Parmanand Jain

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Parmanand Jain, MD

Role: PRINCIPAL_INVESTIGATOR

Professor

charushree E jibhkate, Junior resident

Role: STUDY_CHAIR

Junior resident

Locations

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Tata Memorial Hospital

Mumbai, Maharashtra, India

Site Status

Countries

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India

References

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Larue F, Colleau SM, Brasseur L, Cleeland CS. Multicentre study of cancer pain and its treatment in France. BMJ. 1995 Apr 22;310(6986):1034-7. doi: 10.1136/bmj.310.6986.1034.

Reference Type BACKGROUND
PMID: 7728056 (View on PubMed)

van den Beuken-van Everdingen MH, de Rijke JM, Kessels AG, Schouten HC, van Kleef M, Patijn J. Prevalence of pain in patients with cancer: a systematic review of the past 40 years. Ann Oncol. 2007 Sep;18(9):1437-49. doi: 10.1093/annonc/mdm056. Epub 2007 Mar 12.

Reference Type BACKGROUND
PMID: 17355955 (View on PubMed)

Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. doi: 10.1111/j.1751-7176.2008.07572.x.

Reference Type BACKGROUND
PMID: 18453793 (View on PubMed)

Krousel-Wood M, Hyre A, Muntner P, Morisky D. Methods to improve medication adherence in patients with hypertension: current status and future directions. Curr Opin Cardiol. 2005 Jul;20(4):296-300. doi: 10.1097/01.hco.0000166597.52335.23.

Reference Type BACKGROUND
PMID: 15956826 (View on PubMed)

Other Identifiers

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TataMC 1680

Identifier Type: -

Identifier Source: org_study_id

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