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

Pain Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02256202
• Other study ID #: EDCINPT
• Status: Completed
• Phase: N/A
• First received: September 25, 2014
• Last updated: October 22, 2015
• Start date: August 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Qualitouch-HC Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Willingness for therapeutic pain injection in lumbar spine

Exclusion Criteria:

• Cognitive impairment, technical Problems in interviewing patients

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Interview
Monitoring interviews to show medical and economic advantages of given therapy

Locations

Country	Name	City	State
Switzerland	Stadtspital Triemli	Zurich	ZH

Sponsors (2)

Lead Sponsor	Collaborator
Qualitouch-HC Foundation	Mundipharma Pte Ltd.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No