Quality Assurance of Electronic Data Capturing (EDC) in Pain Treatment

Pilot Study of Quality Assurance in Interventional Pain Therapy in the Lumbal Spinal Column. Non-randomised, Evaluative, Multicentral Study Concerning the Applicability of a Tablet-PC.

There are actually no standardized quality assurance procedures included in pain treatment processes.

In this observational, feasibility study the use of tablet-Personal Computer (PC) is tested in pain therapy centres using the validated questionnaire "Activity Index". The acceptance of electronic data capturing is tested in patients and therapy teams (doctors and nurses).

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: Interview

Detailed Description

Regarding the demand for a duly documented efficacy of the therapy applied, a standardized procedure is imperative to show the medical and economic advantages of a given therapy. To obtain valid results, it is necessary to use a standardized process, monitored with a validated questionnaire.

In this multi-center study the Activity Index Questionnaire will be tested regarding its outcome quality regarding usability and patient acceptance. Each center collects data of 10 patients with injection pain therapy. Each patient is interviewed twice and after the 2nd interview each patient will fill out a feasibility questionnaire. During the whole study, the use and consumption of oral analgetic drugs are monitored in a diary. The statistical Analysis is done descriptive. Before entering the study, each patient has to give informed consent to participate. National Registration Guidelines for post market surveillance will be obtained.

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8063
      • Stadtspital Triemli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Back pain patients

Description

Inclusion Criteria:

• Willingness for therapeutic pain injection in lumbar spine

Exclusion Criteria:

• Cognitive impairment, technical Problems in interviewing patients

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Tablet-PC in interviewing pain patients	The feasibility of the Tablet-PC in EDC will be assessed by standardized interviews (three times) of the study doctor, the study nurse and the patient.	6-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Problems in application of EDC in Tablet-PC	We measure the Problems of the Application of the EDC, e.g. Patient can't ush the button to answer the questions, e.g. some patients do not understand a question. The answers are usually given by Likert scales.	12 months

Collaborators and Investigators

• Sponsor: Qualitouch-HC Foundation
• Collaborators: Mundipharma Pte Ltd.
• Investigators: Principal Investigator: Robert Theiler, Stadtspital Triemli Zurich, Department of Rheumatology

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: September 25, 2014
• First Submitted That Met QC Criteria: September 30, 2014
• First Posted (Estimate): October 3, 2014

Study Record Updates

• Last Update Posted (Estimate): October 23, 2015
• Last Update Submitted That Met QC Criteria: October 22, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: EDCINPT