Trial document
This trial has been registered retrospectively.
DRKS00013638
Trial Description
Title
Assistant to activate patients with dementia and their caregivers
Trial Acronym
MobiAssist
URL of the Trial
Brief Summary in Lay Language
In the course of dementia physical and mental abilities are declining. In the project MobiAssist an exergame is developed in order to improve and maintain the physical and mental performance of patients with dementia. The exercise program includes strength and coordination exercises as well as mental and biographical stimulation. Training takes place in front of the TV; control is based on MS Kinect. This makes it easy for users to engage in physical activity. Thus, MobiAssist helps to improve the quality of life of people with dementia and to support the disease prevention of dementia patients in their home.
Brief Summary in Scientific Language
Symptoms of dementia are not only the decline of mental but also physical abilities. Activities of daily living decreases as the degree of dementia increases, and the scope of support and care requirements increases accordingly. Activities that stimulate or train mental and physical performance are reduced or even abandoned. The vast majority of care for those suffering from dementia, especially with incipient dementia, is managed in private, i.e. implemented in the respective domestic environment and in many cases carried out by family members. Studies addressing home care of dementia patients have revealed that caregivers of dementia sufferers are significantly more burdened than those of non-dementia patients.
Objectives of the project are to improve or maintain physical and cognitive functions and thus to strengthen independence and everyday skills. Furthermore, the work of caring relatives and caregivers is facilitated.
This is realized with the help of information and communication technology. For the exercise program exergames were developed in which power and coordination as well as cognitive exercises are playfully implemented. The exercises of the training can be planned in the system, documented and subjected to a monitoring procedure. Training takes place at the patient’s home or in care facilities. Integration into the nursing planning of an outpatient or semi-stationary service is possible. The system is connected to various terminals (e.g., tablet) through a secure cloud server, allowing information about the current level of training to be shared by all concerned. MobiAssist also includes an information and training system that can be used to design and deliver training for informal caregivers and caregivers.
Feasibility/usability of the system and effects of the program on physical and cognitive functions, daily activities, and carers burden will be studied in a controlled trial. Procedure: Participants were assessed before, between, and after the control and intervention phase of 16 weeks each. Participants serve as their own controls.
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
- DRKS00013638
- 2018/02/01
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- yes
- Approved
- 160/2017, Deutsche Sporthochschule Köln
Secondary IDs
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Health Condition or Problem studied
- F00 - Dementia in Alzheimer disease
- F01 - Vascular dementia
Interventions/Observational Groups
- Control phase of 16 weeks, no treatment, usual care (prescribed medications, exercise therapy and other therapies will be retained, continuation of all activities as far as possible). Afterwards intervention phase, 16 weeks, MobiAssist-training: at least 3 sessions per week with at least 20 minutes training each session, strength exercises, coordination exercises, and cognitive exercises.
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)
- Prevention
- Other
- II
- N/A
Primary Outcome
Functional status and the extent of support effort using Barthel-Index (Hamburg Classification Manual). Periods: December 2017 until January 2018 (T0), March until April 2018 (T1), July until August 2018 (T2).
Secondary Outcome
1) Extended Barthel-Index (Mahoney & Barthel, 1965).
2) Physical performance (endurance, strength, balance, gait speed, chair stand, mobility) using Short Physical Performance Battery (Guralnik et al., 1994) and Senior Fitness Test (Rikli & Jones, 1999).
3) Cognitive performance (processing speed, memory, working memory, word fluency) using Trail-Making-Test A (Tischler & Petermann, 2010) and DemTect (Kalbe et al., 2004; Kessler et al., 2000).
4) Quality of Life using Quality of Living-AD (Logsdon, 1999).
5) Leasure time activities using PASE (Washburn et al., 1991).
6) Aspects of Usability using System Usability Scale (Brooke, 1996), DART (Amberg et al., 2003) and User Experience Questionnaire (Laugwitz et al., 2008).
7) Trainingadherence (Mode, frequency, duration, level of all single Exergames).
8) Effects of the system/using of technology on aspects of care and daily life using interviews.
Periods: 1)-5): December 2017 until January 2018 (T0), March until April 2018 (T1), July until August 2018 (T2). 6)+7) March until August 2018 (Interventionphase). 8): July until August 2018 (T2).
Countries of Recruitment
- Germany
Locations of Recruitment
- other
- University Medical Center
- other
Recruitment
- Actual
- 2017/12/01
- 45
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- no minimum age
- no maximum age
Additional Inclusion Criteria
1) type of dementia: Alzheimer’s disease or vascular dementia; diagnosed by professionals in memory clinic (CERAD neuropsychological battery); alternative for Siegen: Clinical Dementia Rating (CDR; Morris, 1993) value > 0.5
2) give consent
3) participants are retired
4) participants are mobile and able to stand up from a chair without support and walk 6m
5) care dependency measured by barthel index (BI): criteria: BI< 60 points (Mahoney & Barthel, 1965)
6) support by a professional caregiver or by an informal caregiver
7) written informed consent from patient with dementia and the informal caregiver
8) medical certification
9) cognitive and social requirements (interested, motivated, no aggressive behavior, can imitate exercises, understand simple verbal information, control of emotional reactions)
10) physical requirements (routine actions can be completed; also he/she can: see, hear, speak, sit and stand up, walk, grab and hold on a chair)
11) conditions of the environments (TV with HDMI, wireless internet at home)
Exclusion Criteria
1) other types of dementia (frontotemporal dementia, dementia with Lewy bodies, alcohol-relates brain damage (Korsakoff´s syndrome), familial Alzheimer's disease)
2) mental disorders like depression or generalized anxiety disorder who have not been satisfactorily medicated for at least six months; substance-related disorders in the last 2 years; schizophrenia and other psychological disorders
3) neurodegenerative diseases of the Central Nervous System (CNS), Parkinson’s disease, multiple sclerosis, Amyotrophic Lateral Sclerosis (ALS)
4) cardiovascular diseases: acute cardiac failure, acute cardiac insufficiency, angina pectoris, untreated cardiac arrhythmia or heart valve disease, pacemaker, untreated hypertension - systolic blood pressure >180 mm Hg or diastolic blood pressure > 110 mm Hg; untreated hypotension - < 90/60 mm Hg
5) untreated cancer disease
6) untreated hormone diseases
7) badly controlled diabetes (blood glucose < 6 mmol/L or >15 mmol/L)
8) epilepsy
9) Chronic Obstructive Pulmonary Disease (COPD) grade 4
10) acute infection or fever
11) acute renal insufficiency
12) osteoporosis
13) surgical interventions in the last 6 months
14) taking neuroleptics or benzodiazepine
15) participation in another study for dementia
Addresses
-
start of 1:1-Block address primary-sponsor
- Ambulante Diakonische Dienste gGmbH
- Mr. Harry Feige
- Wichernstraße 40
- 57072 Siegen
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +49-271-3336815
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- harry.feige at diakonie-suedwestfalen.de
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end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address other
- Universität Siegen
- Mr. Prof. Dr. Volker Wulf
- Kohlbettstr. 15
- 57072 Siegen
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- +49-271-7404036
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- volker.wulf at uni-siegen.de
- http://www.uni-siegen.de
end of 1:1-Block address contact other -
start of 1:1-Block address other
- Charité - Universitätsmedizin BerlinForschungsgruppe GeriatrieAG Pflegeforschung
- Mr. PD Dr. Nils Lahmann
- Augustenburger Platz 1
- 13353 Berlin
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- +49-30-450 529066
- +49-30-450 529900
- nils.lahmann at charite.de
- http://iqpw.charite.de
end of 1:1-Block address contact other -
start of 1:1-Block address other
- Kaasa solution GmbH
- Mr. Stefan Jahnke
- Friedenstraße 51
- 50219 Düsseldorf
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- +49-211-73063550
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- stefan.jahnke at googlemail.com
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end of 1:1-Block address contact other -
start of 1:1-Block address other
- C&S Computer und Software GmbH
- Mr. Bruno Ristok
- Wolfsgässchen 1
- 86153 Augsburg
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- +49-821-25820
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- info at cs-ag.de
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end of 1:1-Block address contact other -
start of 1:1-Block address other
- BAGSO Service GmbH
- Ms. Dr. Barbara Keck
- Hans-Böckler-Straße 3
- 53225 Bonn
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- +49-228-5552550
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- keck at bagso-service.de
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end of 1:1-Block address contact other -
start of 1:1-Block address scientific-contact
- Deutsche Sporthochschule Köln
- Ms. Dr. Sabine Eichberg
- Am Sportpark Müngersdorf 6
- 50933 Köln
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49-221-49826145
- +49-221-49826143
- eichberg at dshs-koeln.de
- http://www.dshs-koeln.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Deutsche Sporthochschule Köln
- Ms. Dr. Sabine Eichberg
- Am Sportpark Müngersdorf 6
- 50933 Köln
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49-221-49826145
- +49-221-49826143
- eichberg at dshs-koeln.de
- http://www.dshs-koeln.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Bundesministerium für Bildung und Forschung Dienstsitz Berlin
- Friedrichstraße 130 B
- 10117 Berlin
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
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- http://www.bmbf.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up continuing
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