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

Q

Qualitouch-HC Foundation

Status

Completed

Conditions

Pain

Treatments

Other: Interview

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT02256202
EDCINPT

Details and patient eligibility

About

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).

Full 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.

Enrollment

64 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Willingness for therapeutic pain injection in lumbar spine

Exclusion criteria

  • Cognitive impairment, technical Problems in interviewing patients

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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