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

NCT06037096 | Recruiting

• 1 other identifier: Attend-PE
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Embolism

Keywords

Implementation; Health related quality of life; Intervention; Pulmonary embolism; Health care model

Outcome Measures

Primary Outcomes (2)

• 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.

  6 and 12 month follow-up

• Adherence to the anticoagulant treatment

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

  within the first 6 and 12 months

Secondary Outcomes (10)

• EuroQol 5 Dimensions (EQ-5D)

  6 and 12 month follow-up

• Post-VTE Functional Status Scale (PFVS)

  6 and 12 month follow-up

• Anti-Clot Treatment Scale (ACTS)

  6 and 12 month follow-up

• General Anxiety Disorder-7 (GAD7)

  6 and 12 month follow-up

• Patient Health Questionnaire (PHQ-9)

  6 and 12 month follow-up

Study Arms (1)

Attend-PE

EXPERIMENTAL

Other: Attend-PE model

Interventions

Attend-PE model OTHER

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

Also known as: A structured post-pulmonary embolism follow-up model

Attend-PE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients (≥18 years)
• CT-verified diagnosis of PE

You may not qualify if:

• patients who are not living in Denmark on the extraction date
• patients with a active cancer

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Related Publications (4)

• Lindegaard SF, Hojen AA, Rolving N. Electronic adaptation and danish cross-cultural translation of PEmb-QoL and VEINES-QoL/Sym for patients with venous thromboembolism. J Patient Rep Outcomes. 2024 Feb 26;8(1):21. doi: 10.1186/s41687-024-00698-9.

  PMID: 38407682 BACKGROUND

• Rolving N, Lindegaard SF, Johnsen SP, Grove EL, Kumler T, Valentin JB, Risor BW, Klok FA, Konstantinides S, Hojen AA. Effectiveness and cost-effectiveness of a structured integrated post-pulmonary embolism follow-up care model (Attend-PE): a rationale and protocol for a multicentre clinical pre-post study. BMJ Open. 2024 Dec 11;14(12):e088533. doi: 10.1136/bmjopen-2024-088533.

  PMID: 39663161 BACKGROUND

• Hojen AA, Lindegaard SF, Grove EL, Hansen AL, Larsen TB, Kumler T, Johnsen SP, Rolving N. Development of A structured integrated post-Pulmonary Embolism care model: The Attend-PE model. J Thromb Haemost. 2024 Nov;22(11):3137-3147. doi: 10.1016/j.jtha.2024.06.027. Epub 2024 Aug 8.

  PMID: 39122195 BACKGROUND

• Hansen AL, Hojen AA, Lindegaard SF, Grove EL, Jakobsen C, Rolving N. The Attend-PE model: A feasibility study of a structured follow-up care model for patients with pulmonary embolism. Thromb Res. 2024 Oct;242:109133. doi: 10.1016/j.thromres.2024.109133. Epub 2024 Aug 24.

  PMID: 39216272 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anette A. Højen

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

• Nanna Rolving

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

• Søren P. Johnsen

  Aalborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anette A. Højen

CONTACT

+45 29299114; a.wind@rn.dk

Stine F. Lindegaard

CONTACT

+4525545415; s.lindegaard@rn.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: Pre-post intervention study

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: September 14, 2023
• Study Start: March 15, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)