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Completed

NCT Number: NCT02256202

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

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).

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stadtspital Triemli

Zurich, Canton of Zurich, 8063, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willingness for therapeutic pain injection in lumbar spine

Exclusion criteria

  • Cognitive impairment, technical Problems in interviewing patients

Treatment and study plan

interview

Other

Monitoring interviews to show medical and economic advantages of given therapy

Primary outcomes

  1. Feasibility of Tablet-PC in interviewing pain patients

    Time frame: 6-12 months

    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.

Secondary outcomes

  1. Problems in application of EDC in Tablet-PC

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Qualitouch-HC Foundation

Other

Collaborators

  • Mundipharma Pte Ltd.

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 3, 2014
Registry last updated
Oct 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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