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Implementation of a Structured Post-pulmonary Embolism Follow-up Model

ConditionPulmonary Embolism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAalborg University Hospital

About this trial

Venous thromboembolism (VTE), clinically presenting as deep vein thrombosis or pulmonary embolism (PE) is the third most frequent cardiovascular disease and is associated with substantial short- and long-term morbidity and mortality and high costs of care. In addition negative physical and mental complications following VTE are common. However in terms of PE, there are no structured follow-up programs in Denmark and there is considerable variation in practice patterns of post-PE management both within and between countries.

This project aims to develop, test and implement a structured follow-up care model for patients with PE (The Attend-PE model). This project is a pre-post intervention study and will estimate the effectiveness of implementing the structured follow-up care model on a national level.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adult patients (≥18 years)

CT-verified diagnosis of PE

Disqualifiers

patients who are not living in Denmark on the extraction date

patients with a active cancer

Trial design

Design model

Single group

Treatments tested in this trial

  • Attend-PE model

    Other intervention

    A pulmonary embolism follow-up care model consisting of structured elements for follow-up after discharge from hospital.

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: Attend-PEExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire

42 item covering health-related quality of life after pulmonary embolism. Transformed scale show score from 0-100, where 0 is the worst outcome and 100 is the best outcome.

Time frame
6 and 12 month follow-up
2

Adherence to the anticoagulant treatment

Patients having redeemed ≥80% of the prescribed anticoagulant medication. Using The Danish National Prescription Registry.

Time frame
within the first 6 and 12 months

Secondary outcomes

1

EuroQol 5 Dimensions (EQ-5D)

Covering general Health in five dimension. The scores fall on a scale of -0.757 (worst health state) to 1.0 (best health state).

Time frame
6 and 12 month follow-up
2

Post-VTE Functional Status Scale (PFVS)

Covering functional status in 5 categories of functional limitations. In total 5 grades of functional limitations, where 1 is the worst grade and 5 is the best grade.

Time frame
6 and 12 month follow-up
3

Anti-Clot Treatment Scale (ACTS)

Covering satisfaction with anticoagulant treatment (12-item ACTS Burdens scale and 3-item ACTS Benefits scale). 5-point to 7-point scales, where higher scores indicate higher satisfaction with treatment.

Time frame
6 and 12 month follow-up
4

General Anxiety Disorder-7 (GAD7)

Covering anxiety. Score from 0-3 and total score range from 0 to 21, where 21 is the worst outcome and 0 is the best outcome.

Time frame
6 and 12 month follow-up

Other outcomes

Sponsors and contacts

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Aalborg University Hospital

Lead sponsor

Aarhus University Hospital

Collaborator

Source ClinicalTrials.gov
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