Video-assisted education program for patients with oral anticoagulant treatment – Protocol of a cluster-randomized controlled study

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00000586
• Date of registration: 09/12/2010
• Prospective Registration: Yes
• Primary sponsor: Abteilung Allgemeinmedizin Universitätsmedizin Göttingen
• Public title: Video-assisted education program for patients with oral anticoagulant treatment – Protocol of a cluster-randomized controlled study
• Scientific title: Video-assisted education program for patients with oral anticoagulant treatment – Protocol of a cluster-randomized controlled study - S.A.V.E. save anticoagulation with video-assisted education
• Date of first enrolment: 03/01/2011
• Target sample size: 360
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00000586
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: other; Study design purpose: other
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Jean-François Chenot
• Affiliation: Abteilung AllgemeinmedizinUniversitätsmedizin Greifswald

• Name: Jean-Francois Chenot
• Affiliation: Abteilung AllgemeinmedizinUniversitätsmedizin Greifswald

Key inclusion & exclusion criteria

Inclusion criteria: The inclusion criteria are:
- patients aged 18 or over, receiving OAT and are willing to participate in the study
- in case of dependent patients both they and their care-givers (e.g. care-giving relatives) are willing
Exclusion criteria: Exclusion criteria are:
- inability to give informed consent and no care giver willing to participate in the study
- nursing home residents
- patients only seen in cross cover practices
- patients insufficient to command of German language.

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

Z92.1

I48.19

Personal history of long-term (current) use of anticoagulants

Z92.1
I26
I63
I80
Z29.9
I48.19

Prophylactic measure, unspecified

Cerebral infarction

Phlebitis and thrombophlebitis

Pulmonary embolism

Z29.9

Intervention(s)

Group 1: intervention group: 180 patients who will attend a video-assisted education program for oral anticoagulation consisting of a video, individual education and a brochure.
Group 2: control group: 180 patients who will recieve a brochure only.

Primary Outcome(s)

The aim of this study is to improve patient knowledge about oral anticoagulation. The primary outcome is the number of correctly answered questions from the questionnaire which assesses the knowledge about oral anticoagulation. This questionnaire will be filled out at the beginning of the study, after 4 weeks and after 6 months of patients from both study arms.

Secondary Outcome(s)

Secondary outcomes are time spent in therapeutic range, subjective feeling of safety and complications related to OAT.
We will evaluate patient records for INR-level in the last 12 months and complications in the patient history in the last 6 months.Subjective feeling of safety will be evaluated by a questionnaire after 6 months.All data will be collected by the practice nurses and will be sent coded to our study center.

Secondary ID(s)

U1111-1118-3464

Source(s) of Monetary Support

Bundesministerium für Bildung und Forschung Dienstsitz Berlin

Ethics review

Status: Approved
Approval date: 26/10/2010
Contact:

[e-mail]

Ethikkommission der Universitätsmedizin Göttingen

[phone]

[e-mail]

Results

• Date Completed: 31/03/2011
• URL: http://drks.de/search/en/trial/DRKS00000586#studyResults