Condition category
Signs and Symptoms
Date applied
14/06/2007
Date assigned
16/07/2007
Last edited
02/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

http://www.refonet.de

Contact information

Type

Scientific

Primary contact

Prof Peter Bülau

ORCID ID

Contact details

Buchenstrasse 6
Waldbreitbach
56588
Germany

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

http://www.refonet.de

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

Publication citations

Additional files

Editorial Notes