ImpleMentAll - Towards Evidence-based Tailored Implementation Strategies for eHealth

NCT03652883 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2021-03-11

No results posted yet for this study

Summary

The ImpleMentAll (IMA) project aims to examine the effectiveness of tailored implementation compared to usual implementation of Internet-based Cognitive Behavioural Therapy (iCBT) for patients suffering from common mental disorders in routine practice. Common mental health disorders account for an alarming proportion of the global burden of disease. Being regarded as an evidence-based psychotherapeutic eHealth intervention, Internet- based Cognitive Behavioural Therapy (iCBT), has the potential to answer to this societal challenge by providing an efficacious and efficient treatment from which more people can benefit. ImpleMentAll will develop, apply, and evaluate tailored implementation strategies in the context of on-going eHealth implementation initiatives in the EU and beyond. The objectives are:

1. To develop a generic Integrated Theory-based Framework for Intervention Tailoring Strategies (the ItFits-toolkit) for data-driven tailored implementation of evidence-based eHealth services.
2. To demonstrate the impact of the ItFits toolkit on the implementation of eHealth for common mental disorders.
3. To disseminate the validated toolkit in various healthcare contexts across Europe.

Following a stepped-wedge trial design, the ItFits-toolkit will be introduced in twelve implementation sites in nine countries, and evaluated for its effectiveness in obtaining implementation success. An in-depth process evaluation using a realist evaluation methodology will provide information about the particularities of tailored implementation and the application of the ItFits-toolkit in real implementation work. The resulting ItFits-toolkit will enable data driven evaluation of eHealth implementation projects and its methods, materials, and strategies will provide concrete guidance on tuning implementation interventions to local determinant of practice across a variety of health care systems.

Conditions

  • Tailored Implementation: Online ItFits-toolkit
  • Implementation as Usual

Interventions

OTHER

ItFits-toolkit

The ItFits-toolkit provides evidence-informed methods, materials, knowledge on determinants and implementation strategies, and concrete guidance on tailoring implementation strategies to local determinants of practices, apply them and evaluate their impact. It applies a standardised four-step approach to iteratively develop evidence-informed implementation strategies. The ItFits-toolkit is based on the Normalisation Process Theory (NPT), which suggests that lasting changes in practice only happen through people working together. The ItFits toolkit functions as an online self-help toolkit with minimal support. The toolkit will provide instructions for the IL to establish a core team and to create a sounding board consisting to enable co-creation.

OTHER

Implementation as Usual

IAU refers to any existing efforts to embed and integrate iCBT within an organisation.

Sponsors & Collaborators

  • Region of Southern Denmark

    collaborator OTHER
  • Australian National University

    collaborator OTHER
  • Northumbria University

    collaborator OTHER
  • GGZ inGeest

    collaborator OTHER
  • Badalona Serveis Assistencials

    collaborator OTHER
  • Fondation FondaMental

    collaborator OTHER
  • Get.On

    collaborator UNKNOWN
  • Azienda Sanitaria Locale 3, Torino

    collaborator OTHER
  • Academisch Ziekenhuis Groningen

    collaborator OTHER
  • London School of Hygiene and Tropical Medicine

    collaborator OTHER
  • European Alliance against Depression EV

    collaborator UNKNOWN
  • Zyra Per Shendet Mendor

    collaborator UNKNOWN
  • Qendres se Shendetit the Mireqenies Komunitare

    collaborator UNKNOWN
  • Global alliance of mental illness advocacy networks Europe AISBL

    collaborator UNKNOWN
  • Black Dog Institute

    collaborator UNKNOWN
  • European Commission

    collaborator OTHER
  • VU University of Amsterdam

    lead OTHER

Principal Investigators

  • Christiaan Vis, MA · VU Amsterdam

  • Heleen Riper, PhD · VU Amsterdam

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Albania
  • Australia
  • Denmark
  • France
  • Germany
  • Italy
  • Kosovo
  • Netherlands
  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03652883 on ClinicalTrials.gov