Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
05002
Study information
Scientific title
Acronym
KAPUA
Study hypothesis
1. The communication training of the dependents improves the communicative capacity of the people with aphasia
2. The improvement of the communicative capacity also occurs for people with aphasia, who show no improvement in the symptoms
3. The improvement of the communicative capacity is more intense for people with aphasia who also show an improvement in the symptoms than for affected persons who show no change in the symptoms
Ethics approval
Approval received from the local ethics committee (Landesärztekammer Rheinland-Pfalz, Mainz) on the 30th October 2006.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Aphasia
Intervention
Please note that as of 02/09/09 the status of this record was changed to 'stopped' due to recruitment problems. The trial officially stopped on 15/04/2008.
1. Communication training for people with aphasia and their dependents; training twice for two days within two months and homework
2. Tests (Aachen Aphasia Test [AAT], Aphasia Check List [ACL], Communicative Effectiveness Index [CETI], KAPUA [communication test for people with aphasia and their dependents]) to compare at the beginning, two months later and after eight months from the start.
Control:
Control group without training. Only tests to compare at the beginning, two months later and eight months from the start.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
To prove the improvement of communicative capacity of people with aphasia in special consideration of the communicative part of the dependents.
Secondary outcome measures
To establish an approved and evaluated training program for dependents of people with aphasia.
Overall trial start date
01/03/2007
Overall trial end date
01/05/2009
Reason abandoned
Participant recruitment issue
Eligibility
Participant inclusion criteria
1. German native speaker
2. Aphasia since at least six months
3. Live together with the dependant in the same household
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
120 people with aphasia with one dependant each
Participant exclusion criteria
1. Severe apraxia of speech
2. Severe dysarthria
3. Severe dementia
Recruitment start date
01/03/2007
Recruitment end date
01/05/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Buchenstrasse 6
Waldbreitbach
56588
Germany
Sponsor information
Organisation
Refonet (Germany)
Sponsor details
Postfach 10 07 63
Bad Neuenahr-Ahrweiler
53445
Germany
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Refonet (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary