Middel 4 heads

Who takes care of what in the project?

MIDDEL work packages

WP1: Trial methodology, randomisation, statistical analysis (led by NORCE, Norway)

a) Infrastructure & monitoring

  1. NORCE provides the infrastructure (eCRFs, safe server, database structure and support) and monitoring to ensure high-quality data; all procedures have been established and tested with the pilot cohort.
  2. The European Clinical Research Infrastructure Network (ECRIN) will provide support through their national correspondents in countries where this is available, using a risk-based approach to data quality monitoring (remote monitoring plus on-site monitoring as needed) and ethics submissions.
  3. Recruitment and retention rates are monitored closely.

b) Randomisation & main statistical analyses

NORCE will provide the randomisation of CHUs and conduct the main statistical analyses.

WP2: GMT consensus; barriers and facilitators of GMT and RCS (led by UMCG, Netherlands)

Manual, training and evaluation

UMCG leads the provision of a manual for group music therapy (GMT), based on the European consensus and pilot work. GMT providers will be trained; special attention will be paid to cross-cultural applicability. A process evaluation of both GMT and recreational choir singing (RCS) based on video will estimate the intervention and implementation strategy and quality, including perceived barriers and facilitators and treatment fidelity.
>> Publications:
Janus et al. (2020). Developing consensus description of group music therapy characteristics for persons with dementia. Nordic Journal of Music Therapy.

WP3: RCS consensus (led by UOld, Germany)

Manual, training & evaluation

UOld leads the provision of a manual for recreational choir singing (RCS), similar to the work done for GMT in WP2. RCS providers will be trained in collaboration with all partners. The RCS fidelity assessment will feed into the process evaluation outlined in WP2.

WP4: Biomarkers (led by UMCG, Netherlands)

Sampling, testing & analysis

UMCG will steer the individual assessments and analyses of cortisol/amylase. Saliva sampling will be done at the sites of three partners (NORCE, UMCG, UOld) and tested centrally at the biochemical laboratory of the University of Vienna led by Urs Nater.

WP5: Public participation and involvement (PPI), exploitation (led by UoN, UK)

Develop template for PPI, support implementation, evaluate 

The development of MIDDEL was informed by the priorities, experience and preferences of residents and carers. User 
representatives will continue to be actively involved throughout the trial.
UoN leads this ‘PPI’ aspect of the study and work initially with local groups of people with experience of dementia and dementia care to raise awareness of the project. The template for PPI involvement will then be implemented in each participating country by local researchers with support from UoN.
The objectives are: to underpin the trial with lived experience of dementia that is culturally appropriate; to bring the voice of people with dementia and their carers to the research process, potentially challenging academic assumptions; and to ensure the relevance and applicability of the findings in each country. 

WP6: Coordination, governance, dissemination (led by NORCE, Norway)

Ensure overall integrity,  coordinate communication between partners, disseminate results

NORCE is responsible for the overall integrity of the project, as well as for coordinating communications between partners (in-person and online meetings) and external communication.

The report on the main, pre-planned analyses of the primary endpoint and up until the 12-month follow-up will be submitted to a leading medical journal, led by NORCE and with involvement of all partners. This will include data from all European countries and Australia.
Potential further publications:
  • recruitment and retention strategies for international cluster-randomised multicentre trials of complex interventions in non-medical settings;
  • development of an MCID for the MADRS based on an existing anchor question;
  • inter-relations between outcomes and predictive value of early outcomes for later outcomes;
  • clinical descriptions and qualitative research of therapy processes, including qualitative influences on care home staff, their perception of GMT and RCS and their potential “ripple effects”;
  • barriers and facilitators for implementation, using qualitative interviews and surveys;
  • consensus guidelines for GMT and RCS.
As these publications will be led by different partners, communication between partners is essential to avoid duplication; NORCE will be responsible for coordinating these efforts.
The data and meta-data generated by MIDDEL will be curated and stored in a public repository, such as that of the Norwegian Centre for Research Data (NSD). Dissemination to the wider public will also be done by all partners in their local contexts, but supported by NORCE.