Trial document




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  DRKS00013628

Trial Description

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Title

New Service Delivery Model for Augmentative and Alternative Communication (AAC) Devices and Intervention

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Trial Acronym


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URL of the Trial

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Brief Summary in Lay Language

People who cannot speak or who have difficulty understanding have complex communication needs (CCN) and may need alternative forms of communication such as a communication board or computers/ tablets with speech output. The current service delivery of speech generating devices in Germany has a variety of problems. Some people with CCN are given inappropriate devices for example the device has no pre-stored vocabulary or it may be too difficult for the person to use. Additionally, there may be problems with servicing and maintenance of the device. Therefore, the project MUK, funded by the Federal Joint Committee’s Innovation Fund, aims to test a new Augmentative and Alternative Communication (AAC) service delivery model for people with CCN. The aim of the project is to develop a new service delivery model to improve the communication skills, the quality of life and the participation of people with CCN. The new service delivery goes beyond the existing service delivery contract, which so far involves quality-assured diagnostic and counseling on speech generating devices, by adding the following components: case-management, training and if necessary, intervention therapy in using Augmentative and Alternative Communication (AAC). Three specialized AAC consultation centers across Germany will provide this new service delivery. The new service delivery's effectiveness will be evaluated and compared to the existing service delivery models. The views of stakeholders (e.g., people with CCN, family members) along with the outcomes of the new model will be compared to those of people receiving service under existing contract and those currently receiving standard care.

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Brief Summary in Scientific Language

The current practice of service delivery for people with complex communication needs (CCN), who need Augmentative and Alternative Communication (AAC), (e.g. communication boards, speech generating devices) is characterized by difficulties, including a lack of clarity in the responsibilities of the service providers involved (e.g., medical doctors, speech-therapists, AAC-consultation centers, assistive technology companies). Inappropriate device-provision, missing quality criteria and standards, lack of service and maintenance and large regional differences in service delivery add to these difficulties. Consequently, the project MUK, funded by the Federal Joint Committee’s Innovation Fund, aims to improve individualized service delivery, and thereby the communication skills, quality of life and participation of people who rely on AAC. The new service delivery goes beyond the existing contracts and adds case management, regular training for people needing AAC and if needed AAC intervention therapy. Three specialized AAC consultation centers across Germany will provide the new service delivery.
According to the complexity of the new service delivery and the heterogeneity of the people with CCN a formative and summative evaluation of the service will be undertaken. The formative evaluation will provide data based on qualitative and quantitative assessments of the stakeholders’ skills and perspectives. The summative evaluation (a quasi-experimental longitudinal study) will examine the effectiveness of the new service delivery compared to the service delivery under existing contract and the standard care. To date, due to challenges with the data collection from people with CCN, case studies have been the main method used to evaluate AAC services. Therefore, this new study design is an important step towards developing evidence-based practice in AAC.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013628
  •   2018/02/05
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  •   yes
  •   Approved
  •   2017-137, Medizinische Ethikkommission der Carl von Ossietzky Universität Oldenburg
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Secondary IDs

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Health Condition or Problem studied

  •   F07 -  Personality and behavioural disorders due to brain disease, damage and dysfunction
  •   F84 -  Pervasive developmental disorders
  •   G40 -  Epilepsy
  •   G80 -  Cerebral palsy
  •   I60 -  Subarachnoid haemorrhage
  •   Q75 -  Other congenital malformations of skull and face bones
  •   Q87.2 -  Congenital malformation syndromes predominantly involving limbs
  •   Q90 -  Down syndrome
  •   Q93.5 -  Other deletions of part of a chromosome
  •   G10 -  Huntington disease
  •   G20.9 -  [generalization G20: Parkinson disease]
  •   G35 -  Multiple sclerosis
  •   R47 -  Speech disturbances, not elsewhere classified
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Interventions/Observational Groups

  •   New service delivery (nSD): Patients in the intervention group, who are insured at AOK Rheinland/Hamburg, receive the new care model. The model goes beyond the current service delivery under existing contract by adding e.g. patient training and therapy. There will be a baseline measurement and two follow-ups using a quantitative survey and additional qualitative methods. The nSD arm will be compared with the service delivery under existing contract (SDeC) and the standard care (SC).
  •   Service delivery under existing contract (SDeC): In this arm, the subjects receive care according to the standards of the current service delivery contract in which people with complex communication needs receive a communication aid system consisting of diagnostic and communication device counseling. There will be a baseline measurement and two follow-ups using a quantitative survey. The SDeC arm will be compared with the new service delivery (nSD) and the standard care (SC).
  •   Standard care (SC):This group includes insured members of the AOK Lower Saxony who received a communication aid during the period 2014-2018. In regard to this care model the subjects are survey retrospectively. The collected data will be compared to data from the new service delivery (nSD) and the service delivery under existing contract (SDeC).
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group), Historical
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome within the summative evaluation is pragmatic communication skills as the ability to communicate in everyday situations (such as greeting, agreeing, rejecting). These parameters are collected using a survey instrument which is adapted to the target group and based on the Pragmatics Profile subscale of the diagnostic assessment “The Clinical Evaluation Language Fundamentals” (CELF-5) and the COCP program.

There will be one baseline measurement and two follow-ups (T0-T2):

T0: Standardized survey of informal and formal caregivers a few days after the initial consultation (only in the prospective comparison groups with the new service delivery (nSD) and the service delivery under existing contract (SDeC))

T1: Standardized survey of informal and formal caregivers about 4 weeks after service delivery of speech generating devices (only in the prospective comparison groups with the new service delivery (nSD) and the service delivery under existing contract (SDeC))

T2: Standardized survey of informal and formal caregivers about 4 months after service delivery of speech generating devices (only in the prospective comparison groups with the new service delivery (nSD) and the service delivery under existing contract (SDeC)) and retrospective survey of informal and formal caregivers (effective date) in the standard care (SC)

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Secondary Outcome

The DISABKIDS questionnaire is used to measure the secondary outcome "quality of life". It is an instrument for measuring the health-related quality of life of chronically diseased children aged 8 to 18 years. The instrument was adapted to the target group.
The validated short version of the questionnaire WHODAS 2.0 is used to measure the secondary outcome "participation".
The tool QUEST 2.0-G is used to assess the secondary outcome of user satisfaction with technical aids.

There will be one baseline measurement and two follow-ups (T0-T2):

T0: Standardized survey of informal and formal caregivers a few days after the initial consultation (only in the prospective comparison groups with the new service delivery (nSD) and the service delivery under existing contract (SDeC))

T1: Standardized survey of informal and formal caregivers about 4 weeks after service delivery of speech generating devices (only in the prospective comparison groups with the new service delivery (nSD) and the service delivery under existing contract (SDeC))

T2: Standardized survey of informal and formal caregivers about 4 months after service delivery of speech generating devices (only in the prospective comparison groups with the new service delivery (nSD) and the service delivery under existing contract (SDeC)) and retrospective survey of informal and formal caregivers (effective date) in the standard care (SC)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
  • other 
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Recruitment

  •   Actual
  •   2018/06/01
  •   840
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Inclusion criteria for the patients in the three study groups are - apart from the respective care model and the health insurance membership - the presence of a congenital or acquired severe disability which is associated with the absence or loss of speech and / or speaking ability (usually F84 or R 47 in combination with other neurophysiological injuries according to ICD-10). Reliable data on the prevalence are missing. Extrapolations on the basis of larger studies in schools and statistics on frequencies of individual diagnoses show a prevalence of 1.04 % in Germany in relation to the nationwide population – resulting in about 840,000 patients. The patients’ age group covers the entire spectrum from the toddler to the very old. Instead of the patients their informal and formal caregivers and health care professionals will be required to complete the questionnaires. Only in the case of qualitative interviews it could be possible to interview patients with sufficient communication skills.

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Exclusion Criteria

Lack of spoken language due to hearing impairment/deafness (exception/inclusion: patients with hearing impairment and multiple disabilities)

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Addresses

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    • Humanwissenschaftliche Fakultät, Universität zu Köln
    • Mr.  Prof. Dr.   Jens  Boenisch 
    • Habsburger Ring 1
    • 50674  Köln
    • Germany
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    • Department für Versorgungsforschung, Universität Oldenburg
    • Ms.  Prof. Dr.  Lena  Ansmann 
    • Ammerländer Heerstr. 140
    • 29123  Oldenburg
    • Germany
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    • Department für Versorgungsforschung, Universität Oldenburg
    • Ms.  Sarah  Uthoff 
    • Ammerländer Heerstr. 140
    • 29123  Oldenburg
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsfonds des Gemeinsamen Bundesausschusses
    • Wegelystraße 8
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.