- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06127472
Psychoeducation for Older Adults With Autism (OPAS)
Support With Psychoeducation for Older Adults With Autism Study
Until recently, autism in older adults went unrecognised. Although there has been more attention to autism in older adults in recent years, there is still a lot of unfamiliarity with the phenomenon and underdiagnosis in (mental) health care. Many care providers are reluctant to diagnose autism in later life, due to a lack of knowledge about autism in older adults and because there is still very little scientific knowledge available for this target group. Although several multidisciplinary guidelines for autism in adults prescribe that after the diagnosis psycho-education is the first step in treatment, psycho-education is still only offered in a few places in the Netherlands. Psycho-education is important to help older people gain knowledge about their autism, to help them understand and accept this diagnosis, in order to subsequently make the treatment of the problems, with which they turn to the mental health care, more appropriate and effective.
The aim of this study is to contribute to better recognition and diagnosis of autism among older adults. This research also aims to improve a psycho-education program for older adults and investigate its effects.
The scientific research question is whether training in ASD for health care professionals results in better recognition and detection of ASD in older adults, and whether participation in the psycho-education course for older adults, who have recently been diagnosed with autism, contributes to improvement of mental health and quality of life.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The detection of autism spectrum disorder (ASD) in older adults in Dutch (specialised) mental health care is improving, but underdiagnosis remains. Older adults with ASD experience a low quality of life (QoL) and a high rate of psychopathology across the life span and into old age. Additionally, Dutch and international treatment guidelines advocate psychoeducation (PE) as the first intervention after patients have been diagnosed with ASD. However, as PE for older patients with ASD is hardly available in the Netherlands, access to PE is severely limited for these older adults. Hence, it is important to improve detection and diagnosis of ASD and increase the availability of PE for older adults. The hypotheses of this study are 1) that detection and diagnosis of ASD in older adults will significantly increase following training of professionals and 2) that delivering an adapted and improved PE program for older adults will result in more knowledge and recognition of ASD, a better acceptance of the diagnosis, improved coping with ASD, improved resilience and comorbid general psychological distress, and ultimately in higher quality of life, compared to those patients with ASD that receive no PE.
The aim of this study on the one hand is to gain insight into: 1) the effects of providing training and education to mental health care providers in detection and diagnosis of ASD in older adults, with the expectation that this contributes to an increase in the number and proportion of ASD diagnoses in older adults in the Netherlands; 2) the effects of a PE program for older adults with ASD in terms of knowledge and recognition of ASD and traits, a better acceptance of the diagnosis, improved coping with ASD, improved resilience and comorbid general psychological distress - and ultimately higher quality of life; and 3) the experiences of older adults with ASD following the PE program.
Study design: The effects of training and education in detection and diagnosis of ASD in older adults, and the effects of the PE program will be evaluated in a Stepped Wedge Trial Design (SWTD), with the intervention sequentially rolled-out in ten (specialised) mental healthcare organisations. Furthermore, a pre-post design will be used to compare the situation before the roll-out period with the situation after the roll-out period in terms of diagnosis and individual outcomes such as knowledge regarding ASD. Qualitative measures will be used to assess the experiences of older adults with ASD who participated in the PE program.
Study population: Older adults - aged 60 and over diagnosed with ASD no longer than 12 months before the start of the intervention by a multidisciplinary team according to the Dutch multidisciplinary guidelines, as confirmed by the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) interview for ASD, or the Netherlands Interview for Diagnosis of ASD in adults (NIDA) as well as a proxy (an individual who provides reports on behalf of, or about, a study participant).
The intervention consists of education in detection and diagnosis of ASD in older adults for mental health professionals and of an adapted PE program for older adults with a recent diagnosis of ASD. The PE program consists of seven, two hour group meetings on a weekly basis.
Primary study parameter concerns clinical outcomes measuring effects of the psycho-education course in terms of quality of life, acceptance of the diagnosis, knowledge of ASD, recognition of ASD traits, coping with ASD, quantitative autistic traits, resilience, and comorbid psychological distress. Quality of life is assessed by the MHQoL-7 (Mental Health Quality of Life Questionnaire). Acceptance of the diagnosis, knowledge and coping with ASD are assessed with use of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis (VKHAA). Acceptance of ASD (-diagnosis) is further assessed through the Acceptance Questionnaire (AQ). Autistic traits are assessed through the Social Responsiveness Scale-Adults (SRS-A). Comorbid psychological distress is assessed by the Brief Symptom Inventory (BSI). All these assessments are performed (1) at baseline (following diagnosis and informed consent); (2) before the patient starts with PE (on average three months after baseline; participants in the control group will receive this three months after baseline; (3) after the PE (on average two months after the start of the PE program; participants in the control group will receive this measurement 6 months after baseline); (4) at 9-months follow-up (nine months after second measurement). A proxy, chosen by the study participant, will additionally inform on acceptance, knowledge, recognition, coping and ASD traits through measurements on the VKHAA for informants (VKHAA-N) and SRS-A for informants (SRS-A-N) at two moments that overlap with measurements 2 and 3 of study participants.
Secondary study parameters is the number and proportion of ASD diagnoses in the participating centres (collected from the information and registration systems of the mental health care centres) from one year before, during the project, and at one year follow-up.
For patients, benefits will be considerable as they will receive a PE program that is recommended by the Dutch multidisciplinary guideline for ASD in adults, and although being the recommended first intervention by treatment guidelines, is not provided to them momentarily. The benefits account for patients who provide informed consent to participate in the research and patients who do not give their consent, since the same treatment will be available for both. The investigators consider the burden of participating in the research, which consists of filling out questionnaires and inviting a proxy of their choice to fill out two of the same questionnaires, to be limited. Firstly, because this will be done in the context of treatment that fits the recommended first intervention by treatment guidelines and thus does not provide an extra mental burden. Moreover, the time needed to fill out these questionnaires is limited: approximately 40 to 60 minutes per measurement point, and there are no indications that risks are involved with regard to the topics of these questionnaires; specifically in a similar study by the study's research group, no adverse events or risks were observed.
Additional potential benefits exist in the form of increased detection and diagnosis of ASD in older adults across participating organisations, while the burden of participating in the study hardly exceeds time and effort spent in diagnostic efforts as usual, yet lightens efforts spent on informing patients with an ASD diagnosis as this can be done in a group format rather than on an individual basis. The only extra effort is limited to informing patients about the study with verbal and written information.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arjan Videler, Dr.
- Phone Number: +31 (NL) +3188-0162336
- Email: a.c.videler@tilburguniversity.edu
Study Contact Backup
- Name: Ileen Verbeek, Msc., LLM.
- Phone Number: +31 (NL) +316 17501397
- Email: i.c.verbeek@tilburguniversity.edu
Study Locations
-
-
Gelderland
-
Apeldoorn, Gelderland, Netherlands, 7334 DZ
- GGNet Ouderen (Elderly)
-
Contact:
- G. (Gea) de Kaste, Ba.
-
-
Limburg
-
Heerlen, Limburg, Netherlands, 6419PJ
- Mondriaan Ouderen (Elderly)
-
Contact:
- S. (Bas) PJ van Alphen, Prof. Dr.
-
Venray, Limburg, Netherlands, 5804 AV
- Vincent van Gogh Ouderen (Elderly)
-
Contact:
- M. (Michelle) Schaal, MSc.
-
-
Noord-Brabant
-
Den Bosch, Noord-Brabant, Netherlands, 5223 GZ
- Reinier van Arkel
-
Contact:
- J. (Juul) Heijmink, MSc.
-
Eindhoven, Noord-Brabant, Netherlands, 5623 KW
- GGzE Nestor
-
Contact:
- E. (Ellen) Nobel, Dr.
-
Eindhoven, Noord-Brabant, Netherlands, 5632 CW
- SeneVita GGZ
-
Contact:
- F. (Frédérique) Geven, Drs.
-
Halsteren, Noord-Brabant, Netherlands, 4661AA
- GGz WNB Ouderen (Elderly)
-
Contact:
- I. (Ingeborg) Wirken, Drs.
-
Tilburg, Noord-Brabant, Netherlands, 5025JE
- GGz Breburg PersonaCura
-
Contact:
- A. (Arjan) C. Videler, Dr.
-
-
Noord-Holland
-
Hoorn, Noord-Holland, Netherlands, 1624 NP
- GGz NHN Frailty
-
Contact:
- M. (Marjolijn) Hoekert, Dr.
-
-
Overijssel
-
Enschede, Overijssel, Netherlands, 7546 TA
- GGz Mediant
-
Contact:
- B. (Bahar) Kara, MSc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- minimum of 60 years old.
- recently (≤ 12 months) diagnosed with ASD by a multidisciplinary team according to the Dutch multidisciplinary guideline, as confirmed by the DSM-5 interview for ASD (Spek, n.d.), or the Netherlands Interview for Diagnosis of ASD in adults (NIDA; Vuijk, 2023)
Exclusion Criteria:
- comorbid mental disorder that needs acute treatment and severely interferes with a group treatment (for example psychosis),
- a major neurocognitive disorder (for example dementia or acquired brain injury),
- substance abuse disorder, that requires detoxification, and/or
- an IQ below 70.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: ASD trained
Periods in the SWTD after receiving training in detection and diagnosis of ASD.
|
To improve detection and diagnosis of ASD the participating mental health institutes will be trained by the research group on how to detect and diagnose autism in older adults.
The basis of the ASD training involves two separate training sessions.
Part one focuses on recognition and detection of ASD, specifically in older adults, and will be offered to the entire teams of the participating centres.
The second part of the training focuses on the diagnosis of ASD and as such is offered primarily to diagnosticians.
Follow up will consist of monthly recurring options for online consultation during the entire project to discuss clinical cases by experts in ASD in older adults from PersonaCura, clinical centre of excellence for personality and developmental disorders in older adults (dr. A. Videler and R. Wilting).
|
Other: ASD training - control
Periods in the SWTD before receiving training in detection and diagnosis of ASD.
|
To improve detection and diagnosis of ASD the participating mental health institutes will be trained by the research group on how to detect and diagnose autism in older adults.
The basis of the ASD training involves two separate training sessions.
Part one focuses on recognition and detection of ASD, specifically in older adults, and will be offered to the entire teams of the participating centres.
The second part of the training focuses on the diagnosis of ASD and as such is offered primarily to diagnosticians.
Follow up will consist of monthly recurring options for online consultation during the entire project to discuss clinical cases by experts in ASD in older adults from PersonaCura, clinical centre of excellence for personality and developmental disorders in older adults (dr. A. Videler and R. Wilting).
|
Other: PE program
Periods in the SWTD after receiving the PE program.
|
An adapted PE program for older adults with a recent diagnosis of ASD.
The PE program consists of seven, two-hour group meetings on a weekly basis.
|
Other: PE program - control
Periods in the SWTD before receiving the PE program.
|
An adapted PE program for older adults with a recent diagnosis of ASD.
The PE program consists of seven, two-hour group meetings on a weekly basis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life (MHQoL-7)
Time Frame: minimum of 9 to maximum of 15 months with four measurements over this period.
|
Quality of life as measured with the Mental Health Quality of Life-7 (MHQoL-7) a standardized quality of life questionnaire specifically aimed at people with mental health problems.
The MHQoL-7D index score can vary from 0 to 21, with higher scores indicating better quality of life.
|
minimum of 9 to maximum of 15 months with four measurements over this period.
|
Acceptance of the diagnosis
Time Frame: minimum of 9 to maximum of 15 months with four measurements over this period.
|
Acceptance of the diagnosis is based on the combined scores from patients and their chosen proxy on item 31 of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis (VKHAA and VKHAA-N for proxies).
The score on this item is binary with either yes or no scores.
Scores thus range from 0 to 1, with a score of 1 reflecting acceptance as opposed to a score of 0 (no acceptance).
This data further is aggregated with measurements of patients' acceptance of the diagnosis as evaluated with the Acceptance Questionnaire (AQ), a questionnaire with scores ranging from 0 to 33 and higher scores reflecting higher diagnosis acceptance.
Total acceptance scores thus have a range from 0 - 35 and higher scores indicating more acceptance.
|
minimum of 9 to maximum of 15 months with four measurements over this period.
|
Acceptance of the diagnosis from proxy perspective
Time Frame: 8 weeks with two measurements over this period.
|
Acceptance of the diagnosis as reflected by proxies is based on item 31 from the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis for Proxies (VKHAA-N).
The score on this item is binary with either yes or no scores.
Scores thus range from 0 to 1, with a score of 1 reflecting acceptance as opposed to a score of 0 (no acceptance).
|
8 weeks with two measurements over this period.
|
Knowledge of ASD
Time Frame: minimum of 9 to maximum of 15 months with four measurements over this period.
|
Knowledge of ASD is based on measurements on items 1-18 of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis (VKHAA).
Scores range from 0 to 54 with higher scores indicating more knowledge of ASD.
|
minimum of 9 to maximum of 15 months with four measurements over this period.
|
Knowledge of ASD from proxy perspective
Time Frame: 8 weeks with two measurements over this period.
|
Knowledge of ASD as reflected by proxy perspective is based on measurements on items 1-18 of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis for Proxies (VKHAA-).
Scores range from 0 to 54 with higher scores indicating more knowledge of ASD.
|
8 weeks with two measurements over this period.
|
Recognition of ASD traits
Time Frame: minimum of 9 to maximum of 15 months with four measurements over this period.
|
Recognition of ASD is based on measurements on items 20-25 of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis (VKHAA).
Minimum to maximum values are 0 through 24, with higher scores reflecting more recognition of ASD.
|
minimum of 9 to maximum of 15 months with four measurements over this period.
|
Recognition of ASD traits from proxy perspective
Time Frame: 8 weeks with two measurements over this period.
|
Recognition of ASD as reflected by the proxy perspective is based on measurements on items 20-25 of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis for Proxies (VKHAA-N).
Minimum to maximum values are 0 through 24, with higher scores reflecting more recognition of ASD.
|
8 weeks with two measurements over this period.
|
Coping with ASD
Time Frame: minimum of 9 to maximum of 15 months with four measurements over this period.
|
Coping with ASD is based on measurements on items 19 and 28-30 of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis (VKHAA).
Scores range from 0 to 15, with higher scores indicating better coping with ASD.
|
minimum of 9 to maximum of 15 months with four measurements over this period.
|
Coping with ASD from proxy perspective
Time Frame: 8 weeks with two measurements over this period.
|
Coping with ASD from the proxy perspective is based on measurements on items 19 and 28-30 of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis for Proxies (VKHAA-N).
Scores range from 0 to 15, with higher scores indicating better coping with ASD.
|
8 weeks with two measurements over this period.
|
Quantitative autistic traits
Time Frame: minimum of 9 to maximum of 15 months with four measurements over this period.
|
Autistic traits are evaluated with use of the Social Responsiveness Scale-Adults (SRS-A).
The questionnaire consists of 4 subscales: Social Awareness (SA), Social Communication (SC), Social Motivation (SM) and Repetitiveness and Rigidity (RR).
Scores on the SRS-A range from 64 to 256 with higher scores reflecting more autistic traits.
|
minimum of 9 to maximum of 15 months with four measurements over this period.
|
Quantitative autistic traits from proxy perspective
Time Frame: 8 weeks with two measurements over this period.
|
Autistic traits from the proxy perspective are evaluated with use of the Social Responsiveness Scale-Adults for proxies, the SRS-A-N.
The questionnaire consists of 4 subscales: Social Awareness (SA), Social Communication (SC), Social Motivation (SM) and Repetitiveness and Rigidity (RR).
Scores on the SRS-A-N range from 64 to 256 with higher scores reflecting more autistic traits.
|
8 weeks with two measurements over this period.
|
Resilience
Time Frame: minimum of 9 to maximum of 15 months with four measurements over this period.
|
Resilience will be assessed with a 10-item questionnaire, the Connor-Davidson Resilience Scale (CD-RISC-10).
Scores range from 0 - 40 with higher scores indicating greater resilience.
|
minimum of 9 to maximum of 15 months with four measurements over this period.
|
Comorbid psychological distress
Time Frame: minimum of 9 to maximum of 15 months with four measurements over this period.
|
Comorbid psychological distress will be assessed through the Brief Symptom Inventory (BSI).
BSI is a 53-item questionnaire with 9 subscales for somatic complaints, cognitive problems, interpersonal sensitivity, depressive mood, anxiety, hostility, phobia, paranoia and psychoticism.
Scores range from 0 - 212 with higher scores indicating higher presence of psychological complaints.
|
minimum of 9 to maximum of 15 months with four measurements over this period.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of ASD diagnoses
Time Frame: Collection of data concerns numbers per month, starting from one year before, during the expected 18 months of the roll out of the ASD training intervention, and at one year follow-up following roll out of this training in the last cluster of the SWTD.
|
The number of ASD diagnoses collected from the information and registration systems of the participating mental health care centres.
|
Collection of data concerns numbers per month, starting from one year before, during the expected 18 months of the roll out of the ASD training intervention, and at one year follow-up following roll out of this training in the last cluster of the SWTD.
|
Proportion of ASD diagnoses
Time Frame: Collection of data concerns numbers per month, starting from one year before, during the expected 18 months of the roll out of the ASD training intervention, and at one year follow-up following roll out of this training in the last cluster of the SWTD.
|
The proportion of ASD diagnoses collected from the information and registration systems of the participating mental health care centres.
|
Collection of data concerns numbers per month, starting from one year before, during the expected 18 months of the roll out of the ASD training intervention, and at one year follow-up following roll out of this training in the last cluster of the SWTD.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Descriptives
Time Frame: At informed consent (zip code) and the baseline measurement (gender, age, education level), which averages the first two weeks of participants' inclusion in the study.
|
For descriptives, demographic information, concerning gender, age, zip code and education level will be gathered.
|
At informed consent (zip code) and the baseline measurement (gender, age, education level), which averages the first two weeks of participants' inclusion in the study.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Arjan Videler, Dr., Tilburg University, GGz Breburg
Publications and helpful links
General Publications
- Campbell-Sills L, Stein MB. Psychometric analysis and refinement of the Connor-davidson Resilience Scale (CD-RISC): Validation of a 10-item measure of resilience. J Trauma Stress. 2007 Dec;20(6):1019-28. doi: 10.1002/jts.20271.
- van Krugten FCW, Busschbach JJV, Versteegh MM, Hakkaart-van Roijen L, Brouwer WBF. The Mental Health Quality of Life Questionnaire (MHQoL): development and first psychometric evaluation of a new measure to assess quality of life in people with mental health problems. Qual Life Res. 2022 Feb;31(2):633-643. doi: 10.1007/s11136-021-02935-w. Epub 2021 Jul 9.
- de Beurs, E. (2011). Brief Symptom Inventory-BSI. Handleiding herziene editie 2011. Leiden: PITS BV.
- Cage E, Di Monaco J, Newell V. Experiences of Autism Acceptance and Mental Health in Autistic Adults. J Autism Dev Disord. 2018 Feb;48(2):473-484. doi: 10.1007/s10803-017-3342-7.
- Verbeek, I.C., Wedjelek, J., Elfeddali, I., & Videler, A.C. (2023). Acceptance Questionnaire Dutch translation. In development.
- Verbeek, I.C., Lenders, M.A.C.., van Alphen, S.P.J., Elfeddali, I., & Videler, A.C., (2023a). Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis. In development.
- Verbeek, I.C., Lenders, M.A.C, van Alphen, S.P.J., Elfeddali, I., & Videler, A.C., (2023b). Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis for Proxies. In development.
- Constantino, J.N., & Gruber, C.P. (2016). SRS-A Screeningslijst voor autismespectrumstoornissen: Handleiding. Hogrefe. [Dutch Handbook for the Social Responsiveness Scale for Adults]
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL84067.028.23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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