NCT02804477

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

June 13, 2016

Last Update Submit

April 25, 2017

Conditions

Keywords

adherenceopioidMMAS 8, morisky medication adherence scalevalidation

Outcome Measures

Primary Outcomes (1)

  • validation and assessment of adherence to opioids for chronic cancer pain in pain clinic using Morisky medication adherence scale 8

    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.

    six months

Secondary Outcomes (1)

  • relationship of adherence to opioids with demographic characteristics

    six months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients visiting to pain clinic( private and general) will be screened and enrolled according to inclusion and exclusion criteria

You may qualify if:

  • All adult patients \> 18 yrs. of age
  • 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

You may not qualify if:

  • Refusal of consent
  • Paediatric patients
  • Patients who cannot understand or communicate Hindi

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400094, India

Location

Related Publications (4)

  • 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.

    PMID: 7728056BACKGROUND
  • 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.

    PMID: 17355955BACKGROUND
  • 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.

    PMID: 18453793BACKGROUND
  • 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.

    PMID: 15956826BACKGROUND

Study Officials

  • Parmanand Jain, MD

    Professor

    PRINCIPAL INVESTIGATOR
  • charushree E jibhkate, Junior resident

    Junior resident

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 13, 2016

First Posted

June 17, 2016

Study Start

June 1, 2016

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations