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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03652883




Registration number
NCT03652883
Ethics application status
Date submitted
20/08/2018
Date registered
29/08/2018
Date last updated
11/03/2021

Titles & IDs
Public title
ImpleMentAll - Towards Evidence-based Tailored Implementation Strategies for eHealth
Scientific title
ImpleMentAll - Towards Evidence-based Tailored Implementation Strategies for eHealth
Secondary ID [1] 0 0
1
Universal Trial Number (UTN)
Trial acronym
ImpleMentAll
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tailored Implementation: Online ItFits-toolkit 0 0
Implementation as Usual 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - ItFits-toolkit
Other interventions - Implementation as Usual

Experimental: ItFits-toolkit - A generic 'Integrated Theory-based Framework for Implementation Tailoring Strategies' toolkit (the ItFits-toolkit) functions as an online self-help toolkit by which users are guided through the process of tailoring site-specific implementation strategies. The ItFits-toolkit includes four modules that implementers need to work through: 1) identifying and prioritising implementation goals and determinants of practices, 2) matching up implementation determinants to strategies, 3) designing a plan for carrying out strategies in a local context, and 4) applying strategies, and reviewing progress. In each of these four modules, evidence-informed materials such as iCBT relevant determinants of practices and implementation strategies, are included as well as methods for engaging with stakeholders.

Active comparator: Implementation as Usual - Implementation-as-Usual (IAU) refers to any existing approaches and efforts to embed and integrate iCBT within an organisation. All implementation sites included in IMA are engaged in and conducting IAU. IAU activities can be, but are not necessarily planned or guided by scientific evidence and often emerge from practice experiences and other sources of information. No standardisation in IAU across the sites is applied except for the implementation objective. That is, all implementation sites pursue the goal of increasing the number of patients treated by the iCBT service.


Other interventions: 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 interventions: Implementation as Usual
IAU refers to any existing efforts to embed and integrate iCBT within an organisation.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Uptake - referral rate (organisation level)
Timepoint [1] 0 0
Month 0, repeated every three months until month 27.
Primary outcome [2] 0 0
Change in Uptake - completion rate (organisation level)
Timepoint [2] 0 0
Month 0, repeated every three months until month 27.
Primary outcome [3] 0 0
Change in Normalisation (staff level)
Timepoint [3] 0 0
Month 0, repeated every three months until month 27.
Primary outcome [4] 0 0
Change in Efficiency (organisation level)
Timepoint [4] 0 0
Month 0, repeated every three months until month 27.
Secondary outcome [1] 0 0
Exposure to the ItFits-toolkit (organisation level)
Timepoint [1] 0 0
Month 0, continuous log until month 27.
Secondary outcome [2] 0 0
Satisfaction with the ItFits-toolkit (organisation level)
Timepoint [2] 0 0
Month 27
Secondary outcome [3] 0 0
Usability of the ItFits-toolkit (organisation level)
Timepoint [3] 0 0
Month 27
Secondary outcome [4] 0 0
Organisational Readiness for Implementing Change (Staff level)
Timepoint [4] 0 0
Month 0, repeated every three months until month 27.
Secondary outcome [5] 0 0
Perceived impact on site specific implementation goals and determinants (organisational level)
Timepoint [5] 0 0
End of exposure period to the ItFits-toolkit (i.e. 6 months after crossing over from IAU to using the ItFits-toolkit).

Eligibility
Key inclusion criteria
There are two types of study participants, i.e. persons providing data: 1) implementers, and 2) staff involved in iCBT service delivery at the local implementation sites.

Implementers Eligible implementers are individuals who are directly involved in the development, coordination and execution of implementation activities within an implementation site. The implementation sites are the organizations engaged in the implementation processes as well as in iCBT service delivery. The implementation site started the implementation processes at least three months prior to the baseline measurement, and is committed to ongoing implementation of the iCBT service delivery. Implementation sites have been selected and enrolment is closed. Implementers are represented in the local trial by an Implementation Lead (IL) who has a coordinating role in the implementation activities. The IL will collect and provide the data on implementation site level and need to sign an informed consent form. Enrolment of implementers is considered to be open due to possible staff-changes within the participating implementation sites.

Inclusion criteria implementers and IL:

* Individuals that are directly involved in the development, coordination and execution of implementation activities within an implementation site;
* is a reasonably profound user of the English language;
* the IL has a coordinating role in implementing the iCBT service.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria implementers and IL - Involved in trial management.

Staff involved in iCBT service delivery

Staff involved in service delivery are individuals who engage in the commissioning the iCBT service to clients. Staff members can have different roles in the service delivery:

* As therapists such as psychologists, psychiatrists, or mental health nurses.
* As referrers such as GPs, pharmacists, community workers, or case managers.
* As, administrators such as clerical workers, or secretariats.
* As ICT support such as security officers, maintenance officers, or helpdesk staff.

Inclusion criteria service delivery staff:

* Involved in the delivery of the iCBT service
* In a process of adapting their current way of working in order to deliver iCBT service to patients in routine care.

Exclusion criteria service delivery staff:

- Enrolled in the trial as implementer.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2020
Sample size
Target
Accrual to date
Final
456
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
ANU - Camberra
Recruitment hospital [2] 0 0
BDI - Sydney
Recruitment postcode(s) [1] 0 0
- Camberra
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Albania
State/province [1] 0 0
Tirana
Country [2] 0 0
Denmark
State/province [2] 0 0
Odense
Country [3] 0 0
France
State/province [3] 0 0
Toulouse
Country [4] 0 0
Germany
State/province [4] 0 0
Erlangen
Country [5] 0 0
Germany
State/province [5] 0 0
Leipzig
Country [6] 0 0
Italy
State/province [6] 0 0
Turin
Country [7] 0 0
Kosovo
State/province [7] 0 0
Prizren
Country [8] 0 0
Netherlands
State/province [8] 0 0
Amsterdam
Country [9] 0 0
Netherlands
State/province [9] 0 0
Groningen
Country [10] 0 0
Spain
State/province [10] 0 0
Badalona

Funding & Sponsors
Primary sponsor type
Other
Name
VU University of Amsterdam
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Region of Southern Denmark
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australian National University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Northumbria University
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
GGZ inGeest
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Badalona Serveis Assistencials
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Fondation FondaMental
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Get.On
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Azienda Sanitaria Locale 3, Torino
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Academisch Ziekenhuis Groningen
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
London School of Hygiene and Tropical Medicine
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
European Alliance against Depression EV
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
Zyra Per Shendet Mendor
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
Qendres se Shendetit the Mireqenies Komunitare
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
Global alliance of mental illness advocacy networks Europe AISBL
Address [14] 0 0
Country [14] 0 0
Other collaborator category [15] 0 0
Other
Name [15] 0 0
Black Dog Institute
Address [15] 0 0
Country [15] 0 0
Other collaborator category [16] 0 0
Other
Name [16] 0 0
European Commission (funder)
Address [16] 0 0
Country [16] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT03652883
Trial related presentations / publications
Doukani A, Cerga Pashoja A, Fanaj N, Qirjako G, Meksi A, Mustafa S, Vis C, Hug J. Organizational Readiness for Implementing an Internet-Based Cognitive Behavioral Therapy Intervention for Depression Across Community Mental Health Services in Albania and Kosovo: Directed Qualitative Content Analysis. JMIR Form Res. 2021 Nov 1;5(11):e29280. doi: 10.2196/29280.
Buhrmann L, Schuurmans J, Ruwaard J, Fleuren M, Etzelmuller A, Piera-Jimenez J, Finch T, Rapley T, Potthoff S, Aouizerate B, Batterham PJ, Calear A, Christensen H, Pedersen CD, Ebert DD, Van der Eycken E, Fanaj N, van Genugten C, Hanssen D, Hegerl U, Hug J, Kleiboer A, Mathiasen K, May C, Mustafa S, Oehler C, Cerga-Pashoja A, Pope C, Qirjako G, Rosmalen J, Sacco Y, Samalin L, Skjoth MM, Tarp K, Titzler I, Zanalda E, Zbukvic I, Smit JH, Riper H, Vis C; ImpleMentAll consortium. Tailored implementation of internet-based cognitive behavioural therapy in the multinational context of the ImpleMentAll project: a study protocol for a stepped wedge cluster randomized trial. Trials. 2020 Oct 28;21(1):893. doi: 10.1186/s13063-020-04686-4.
Public notes

Contacts
Principal investigator
Name 0 0
Christiaan Vis, MA
Address 0 0
VU Amsterdam
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03652883