MobilityDESKKNCT03578861
Dementia Specific Respite Care Concept.
A study testing Dementia related mobility and counseling in people with Mobility and Dementia, run by German Center for Neurodegenerative Diseases (DZNE) at 1 site in Germany.
Trial summary
Objectives: Specific mobility programs can delay the functional decline in people with dementia (PwD) and help to preserve their abilities of daily living. Respite care is a common used short time inpatient service (max. 4 weeks of stay) to support dementia care arrangements. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Mobility, Dementia, Counseling
- What is being tested?
- Dementia related mobility and counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 20 Oct 2017to 1 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Caring relatives:
- Willingness to take part at the counseling intervention (informed consent)
- Sufficient language skills to understand the counseling sessions
- CR has to be the primary care person for the PwD
- People with dementia
- Willingness to take part at the rehabilitation intervention (informed consent [if necessary: signing by the primary care person])
Show all 9Show fewer
- Capability to understand and follow (training) instructions with support of the involved training assessors (subjective pre-assessment by raters)
- Capability to stand and walk short distances (min. 3 Meter) with support of the involved training assessors
- Minimum amount of 13 days stay in the RC center (planned)
Who cannot join
- Other severe cognitive impairments or other severe neurological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Pilot Testing of a Dementia Specific Respite Care Concept With Scope on Mobility and Couseling.
Objectives:
Specific mobility programs can delay the functional decline in people with dementia (PwD) and help to preserve their abilities of daily living. Respite care is a common used short time inpatient service (max. 4 weeks of stay) to support dementia care arrangements. Within the DESKK project, a concept is developed which complements and optimizes dementia-specific respite care through a mobility program and a counseling program. As one part of the DESKK study, it is the aim to develop and implement a time effective and evidence based mobility program for PwD in respite care which can be individually adapted on PwD needs and preferences. It includes a short "homework-program" for caring relatives to facilitate ongoing mobility training of the PwD after returned back home.
Read more
Methods:
A pilot based, quasi-experimental evaluation study is conducted in a specialized respite care facility for PwD. The concept was developed on the basis of a comprehensive literature research, study visits at existing counseling programs as well as expert workshops with practitioners and scientists. To evaluate the implementation process, qualitative data are collected by single und group interviews. Quantitative data are collected using validated instruments to assess mobility and cognitive function of PwD. A mixed methods triangulation approach will be used to aggregate qualitative and quantitative data.
Discussion:
It is expected that the RC concept will be suitable and understandable for the staff, so that it can be implemented in the RC facility. As a result of the mobility program, the physical abilities of the PwDs should improve. Similar, the burden of the caregivers should be reduced by combined effects of the counselling program and the higher mobility level of the PwD. The whole DESKK concept, including a systematic counseling program for caring relatives, which is not part of this presentation, will be described in form of a practice friendly website to get disseminated into clinical routine after its successful evaluation.
Read the detailed description
Around the world, caring relatives play the most important role in care of people with dementia (PwD) at home. In 2012 approximately 24.3 million people were affected by dementia worldwide and more than 1.5 million people are suffering from dementia in Germany. These numbers are expected to rise up significantly within the next 20 years. As a direct consequence of dementia-specific care, caring relatives are often heavily burdened. Some common symptoms of dementia include progressive and frequent memory loss as well as confusion, personality change and apathy. Furthermore, the abilities for walking and standing activities get weaker especially because of balance dysfunctions. These symptoms lead to a loss of ability to perform everyday tasks for the PwD and an increased risk of falling. Among others, this situation can destruct the stability of care arrangement at home and lead to a transfer of the PwD to long term care but most PwD have the wish to stay at home if possible.
Respite care (RC) is a common used short term inpatient service with the primary aim to support home care arrangements for PwD and their caring relatives. To reach this aim, caring relatives can bring their cared persons to a specialized RC care facility, where they can stay about 1 to 8 weeks. During this time, RC facilities could develop and implement individual tailored support interventions focused on the concerned PwD and caring relatives to reach a stabilization of their caring situation at home.
However, there are no evaluated or standardized programs for the support of PwD and caring relatives in the RC setting till today. In particular, this is a serious problem because there is an increasing number of RC residents who suffer from cognitive impairments or dementia.
An individual tailored, specific RC concept for people with dementia and their caring relatives could focus on their special needs and help to stabilize the caring situation effectively.
In an actual Cochrane review it was pointed out that there is a high demand for mobility based rehabilitation programs for PwD with significant positive effects related to mobility based ADL abilities. Mobility based interventions generate the highest effects of all other interventions, including medication, related to ADL abilities of PwD and with respect to their level of independence in general. However, few standardized and detailed described programs for mobility based interventions focused on PwD exist until today. There are no structured mobility based rehabilitation programs to support PwD and caring relatives in the RC setting. Another Cochrane review pointed out that situation does not only apply for Germany but even in international context. With scope to caring relatives, professional dementia-specific counseling services have positive effects on the psychological and psychosomatic symptoms, coping with stress and managing behavioral disturbances. To date, there is no dementia-specific counseling programs specialized to the RC setting, though RC facilities have the chance to reach caring relatives, which are often no more accessible for other dementia support services, because of their overburdened situation and thereby very little time resources. However, especially these caring relatives have a strong need for information about dementia and related support services.
Primary aim of the DESKK Study is the development, test and evaluation of a dementia specific RC concept with scope on mobility (PwD) and counseling (caring relatives) referred to its usability and implementation requirements. Furthermore an explorative outcome evaluation will be performed to describe intervention processes of this dementia specific concept focused on RC staff, PwD and caring relatives. To reach these study aims, following research questions are intended to be answered:
- What kind of intervention parts and RC structures/processes are relevant for the development of a dementia specific RC concept focused on an ADL based mobility program for PwD and a counseling program for caring relatives?
- How can the DESKK mobility and counseling program be developed and implemented suitable for the respite care setting?
- What changes occur during the DESKK mobility and counseling intervention related to the PwD and caring relatives?
- How is the DESKK concept subjective rated by the caring relatives and what changes related to burden (CR) and mobility (PwD) occurred after ending the RC stay (Follow-Up).
- Conditions
- Mobility, Dementia, Counseling, Respite Care
- Being tested
- Dementia related mobility and counseling
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dementia related mobility and counselingOther
The DESKK mobility program is based on the already existing day structure of the RC facility with two slots a day for physical activation activities (1 ½ hours forenoon and 1 ½ hours afternoon). The program structures these activities based on specific developed exercises, which are focused on the individual mobility level of every PwD and his/her mobility level.
The DESKK counseling program is an effort to structure and systemize counseling processes focused on the respite care setting by different documents and assessments.
| Study group | Role | What they receive |
|---|---|---|
| Dementia related mobility and counseling | Experimental | The DESKK mobility program is based on the already existing day structure of the RC facility with two slots a day for physical activation activities (1 ½ hours forenoon and 1 ½ hours afternoon). The program structures these activities based on specific developed exercises, which are focused on the individual mobility level of every PwD and his/her mobility level.
The DESKK counseling program is an effort to structure and systemize counseling processes focused on the respite care setting by different documents and assessments. Receives: Other: Dementia related mobility and counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPPB)
The SPPB can be used for the analyses of ADL related capabilities of old people related to gait performance and strength as well related to static balance. This test can also be used for people with cognitive retardation. Furthermore the Instrument is validated and reliable.
Measured: 10 min
Secondary outcomes (6)
Nurses' Observation Scale for Geriatric Patients (NOSGER)
The NOSGER Assessment is a validated and fast usable Instrument for the measurement of challenging behavior during the last 14 days. It can be filled out by nursing staff as well as by caring relatives and has an ADL focus.
Measured: 10 min
Nurses' Observation Scale for Geriatric Patients (MMST)
The MMST is a common and validated instrument to get information about the cognitive status of persons including a rating scale which rated between not and severely cognitive impaired.
Measured: 25 min
Box and Blocks Test (BBT)
The BBT can be used for the analyses of rough coordination skills related to the upper extremity, arms and hand. It is easy and fast to use, validated and reliable.
Measured: 5 min
Strength-Dexterity Test (SD)
The SD is a Hand muscle strength test and can be performed very fast and easily.
Measured: 2 min
Nine-Hole Peg Test (NHPT)
The NHPT can be used for the analyses of fine coordination relates to hands and fingers. It is easy and fast to use, validated and reliable.
Measured: 2 min
Berliner Inventar zu Angehörigenbelastung-Demenz (BIZA-D)
The BIZA-D can be filled out relative time effective and it measures the subjective and objective burden of caring relatives of PwD. It is validated and also mobility based ADL related.
Measured: 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start20 Oct 2017
- Primary completion20 Sep 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for MobilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Center for Neurodegenerative Diseases (DZNE)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernhard Holle, Dr, Principal investigator, DZNE Witten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578861
- Sponsor's protocol ID
- WI025
- Acronym
- DESKK
- Status last verified
- Jun 2018
- First submitted
- 18 Jun 2018
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available based on the informed consent of the participants. Data from the study can be requested from the first author via steffen.heinrich@dzne.de
Publications
Dassen, T. (2009). Bundesweite Erhebung zu Pflegeproblemen 2009. Studie aus Pflegeheimen und Krankenhäusern. Berlin: Charité.
DAlzG. (2016). Informationblatt 1 - Die Häufigkeit von Demenzerkrankungen. Retrieved from https://www.deutsche-alzheimer.de/fileadmin/alz/pdf/factsheets/infoblatt1_haeufigkeit_demenzerkrankungen_dalzg.pdf
WHO. (2012). Dementia - A public health priority. Retrieved from http://whqlibdoc.who.int/publications/2012/9789241564458_eng.pdf
Radenbach K, Retzlik J, Meyer-Rotz SH, Wolff-Menzler C, Wolff J, Esselmann H, Godemann F, Riemenschneider M, Wiltfang J, Jessen F. [Guideline-adherent inpatient psychiatric psychotherapeutic treatment of behavioral and psychological symptoms of dementia : Normative definition of personnel requirements]. Nervenarzt. 2017 Sep;88(9):1010-1019. doi: 10.1007/s00115-016-0195-9. German.
PubMed 27581115Reggentin H. [Caregiver's burden of caring for patients with dementia in group living compared to to domestic and inpatient care]. Z Gerontol Geriatr. 2005 Apr;38(2):101-7. doi: 10.1007/s00391-005-0295-9. German.
PubMed 15868348Shea, T. (2012). Dementia - Understanding brain diseases and disorders. New York: Rosen Publishing.
van Doorn C, Gruber-Baldini AL, Zimmerman S, Hebel JR, Port CL, Baumgarten M, Quinn CC, Taler G, May C, Magaziner J; Epidemiology of Dementia in Nursing Homes Research Group. Dementia as a risk factor for falls and fall injuries among nursing home residents. J Am Geriatr Soc. 2003 Sep;51(9):1213-8. doi: 10.1046/j.1532-5415.2003.51404.x.
PubMed 12919232Forbes D, Forbes SC, Blake CM, Thiessen EJ, Forbes S. Exercise programs for people with dementia. Cochrane Database Syst Rev. 2015 Apr 15;2015(4):CD006489. doi: 10.1002/14651858.CD006489.pub4.
PubMed 25874613Maayan N, Soares-Weiser K, Lee H. Respite care for people with dementia and their carers. Cochrane Database Syst Rev. 2014 Jan 16;2014(1):CD004396. doi: 10.1002/14651858.CD004396.pub3.
PubMed 24435941Kurz A, Hallauer J, Jansen S, Diehl J. [Efficacy of caregiver support groups for dementia]. Nervenarzt. 2005 Mar;76(3):261-9. doi: 10.1007/s00115-004-1759-7. German.
PubMed 15300316Heinrich S, Laporte Uribe F, Roes M, Hoffmann W, Thyrian JR, Wolf-Ostermann K, Holle B. Knowledge management in dementia care networks: a qualitative analysis of successful information and support strategies for people with dementia living at home and their family caregivers. Public Health. 2016 Feb;131:40-8. doi: 10.1016/j.puhe.2015.10.021. Epub 2015 Dec 21.
PubMed 26718421ZQP. (2018). Ein Jahr nach letzter Pflegereform: Pflegende Angehörige sehen Informationsbedarf. Retrieved from https://www.presseportal.de/pm/80067/3876592?utm_source=digest&utm_medium=email&utm_campaign=push
Gomez JF, Curcio CL, Alvarado B, Zunzunegui MV, Guralnik J. Validity and reliability of the Short Physical Performance Battery (SPPB): a pilot study on mobility in the Colombian Andes. Colomb Med (Cali). 2013 Sep 30;44(3):165-71. eCollection 2013 Jul.
PubMed 24892614Mendes MF, Tilbery CP, Balsimelli S, Moreira MA, Cruz AM. [Box and block test of manual dexterity in normal subjects and in patients with multiple sclerosis]. Arq Neuropsiquiatr. 2001 Dec;59(4):889-94. doi: 10.1590/s0004-282x2001000600010. Portuguese.
PubMed 11733833Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PubMed 1202204
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Testing of a Dementia Specific Respite Care Concept With Scope on Mobility and Couseling.
- ClinicalTrials.gov ID
- NCT03578861
- Acronym / sponsor ID
- DESKK / WI025
- Conditions
- Mobility, Dementia, Counseling, Respite Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- German Center for Neurodegenerative Diseases (DZNE)University, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
Specific mobility programs can delay the functional decline in people with dementia (PwD) and help to preserve their abilities of daily living. Respite care is a common used short time inpatient service (max. 4 weeks of stay) to support dementia care arrangements. Within the DESKK project, a concept is developed which complements and optimizes dementia-specific respite care through a mobility program and a counseling program. As one part of the DESKK study, it is the aim to develop and implement a time effective and evidence based mobility program for PwD in respite care which can be individually adapted on PwD needs and preferences. It includes a short "homework-program" for caring relatives to facilitate ongoing mobility training of the PwD after returned back home.
Methods:
A pilot based, quasi-experimental evaluation study is conducted in a specialized respite care facility for PwD. The concept was developed on the basis of a comprehensive literature research, study visits at existing counseling programs as well as expert workshops with practitioners and scientists. To evaluate the implementation process, qualitative data are collected by single und group interviews. Quantitative data are collected using validated instruments to assess mobility and cognitive function of PwD. A mixed methods triangulation approach will be used to aggregate qualitative and quantitative data.
Discussion:
It is expected that the RC concept will be suitable and understandable for the staff, so that it can be implemented in the RC facility. As a result of the mobility program, the physical abilities of the PwDs should improve. Similar, the burden of the caregivers should be reduced by combined effects of the counselling program and the higher mobility level of the PwD. The whole DESKK concept, including a systematic counseling program for caring relatives, which is not part of this presentation, will be described in form of a practice friendly website to get disseminated into clinical routine after its successful evaluation.
Detailed description
Around the world, caring relatives play the most important role in care of people with dementia (PwD) at home. In 2012 approximately 24.3 million people were affected by dementia worldwide and more than 1.5 million people are suffering from dementia in Germany. These numbers are expected to rise up significantly within the next 20 years. As a direct consequence of dementia-specific care, caring relatives are often heavily burdened. Some common symptoms of dementia include progressive and frequent memory loss as well as confusion, personality change and apathy. Furthermore, the abilities for walking and standing activities get weaker especially because of balance dysfunctions. These symptoms lead to a loss of ability to perform everyday tasks for the PwD and an increased risk of falling. Among others, this situation can destruct the stability of care arrangement at home and lead to a transfer of the PwD to long term care but most PwD have the wish to stay at home if possible.
Respite care (RC) is a common used short term inpatient service with the primary aim to support home care arrangements for PwD and their caring relatives. To reach this aim, caring relatives can bring their cared persons to a specialized RC care facility, where they can stay about 1 to 8 weeks. During this time, RC facilities could develop and implement individual tailored support interventions focused on the concerned PwD and caring relatives to reach a stabilization of their caring situation at home.
However, there are no evaluated or standardized programs for the support of PwD and caring relatives in the RC setting till today. In particular, this is a serious problem because there is an increasing number of RC residents who suffer from cognitive impairments or dementia.
An individual tailored, specific RC concept for people with dementia and their caring relatives could focus on their special needs and help to stabilize the caring situation effectively.
In an actual Cochrane review it was pointed out that there is a high demand for mobility based rehabilitation programs for PwD with significant positive effects related to mobility based ADL abilities. Mobility based interventions generate the highest effects of all other interventions, including medication, related to ADL abilities of PwD and with respect to their level of independence in general. However, few standardized and detailed described programs for mobility based interventions focused on PwD exist until today. There are no structured mobility based rehabilitation programs to support PwD and caring relatives in the RC setting. Another Cochrane review pointed out that situation does not only apply for Germany but even in international context. With scope to caring relatives, professional dementia-specific counseling services have positive effects on the psychological and psychosomatic symptoms, coping with stress and managing behavioral disturbances. To date, there is no dementia-specific counseling programs specialized to the RC setting, though RC facilities have the chance to reach caring relatives, which are often no more accessible for other dementia support services, because of their overburdened situation and thereby very little time resources. However, especially these caring relatives have a strong need for information about dementia and related support services.
Primary aim of the DESKK Study is the development, test and evaluation of a dementia specific RC concept with scope on mobility (PwD) and counseling (caring relatives) referred to its usability and implementation requirements. Furthermore an explorative outcome evaluation will be performed to describe intervention processes of this dementia specific concept focused on RC staff, PwD and caring relatives. To reach these study aims, following research questions are intended to be answered:
- What kind of intervention parts and RC structures/processes are relevant for the development of a dementia specific RC concept focused on an ADL based mobility program for PwD and a counseling program for caring relatives?
- How can the DESKK mobility and counseling program be developed and implemented suitable for the respite care setting?
- What changes occur during the DESKK mobility and counseling intervention related to the PwD and caring relatives?
- How is the DESKK concept subjective rated by the caring relatives and what changes related to burden (CR) and mobility (PwD) occurred after ending the RC stay (Follow-Up).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dementia related mobility and counseling | Experimental | Other: Dementia related mobility and counselingThe DESKK mobility program is based on the already existing day structure of the RC facility with two slots a day for physical activation activities (1 ½ hours forenoon and 1 ½ hours afternoon). The program structures these activities based on specific developed exercises, which are focused on the individual mobility level of every PwD and his/her mobility level. The DESKK counseling program is an effort to structure and systemize counseling processes focused on the respite care setting by different documents and assessments. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Willingness to take part at the counseling intervention (informed consent)
- Sufficient language skills to understand the counseling sessions
- CR has to be the primary care person for the PwD
- People with dementia
- Willingness to take part at the rehabilitation intervention (informed consent [if necessary: signing by the primary care person])
Key exclusion criteria (1 listed)
- Other severe cognitive impairments or other severe neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dementia related mobility and counselingThe DESKK mobility program is based on the already existing day structure of the RC facility with two slots a day for physical activation activities (1 ½ hours forenoon and 1 ½ hours afternoon). The program structures these activities based on specific developed exercises, which are focused on the individual mobility level of every PwD and his/her mobility level. The DESKK counseling program is an effort to structure and systemize counseling processes focused on the respite care setting by different documents and assessments. | Other | Dementia related mobility and counseling |
Primary outcome
Short Physical Performance Battery (SPPB)
Time frame: 10 min
The SPPB can be used for the analyses of ADL related capabilities of old people related to gait performance and strength as well related to static balance. This test can also be used for people with cognitive retardation. Furthermore the Instrument is validated and reliable.
6 secondary outcomes
Nurses' Observation Scale for Geriatric Patients (NOSGER)
Time frame: 10 min
Nurses' Observation Scale for Geriatric Patients (MMST)
Time frame: 25 min
Box and Blocks Test (BBT)
Time frame: 5 min
Strength-Dexterity Test (SD)
Time frame: 2 min
Nine-Hole Peg Test (NHPT)
Time frame: 2 min
Berliner Inventar zu Angehörigenbelastung-Demenz (BIZA-D)
Time frame: 15 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- BackgroundDassen, T. (2009). Bundesweite Erhebung zu Pflegeproblemen 2009. Studie aus Pflegeheimen und Krankenhäusern. Berlin: Charité.
- BackgroundDAlzG. (2016). Informationblatt 1 - Die Häufigkeit von Demenzerkrankungen. Retrieved from https://www.deutsche-alzheimer.de/fileadmin/alz/pdf/factsheets/infoblatt1_haeufigkeit_demenzerkrankungen_dalzg.pdf
- BackgroundWHO. (2012). Dementia - A public health priority. Retrieved from http://whqlibdoc.who.int/publications/2012/9789241564458_eng.pdf
- Background: PubMed 27581115Radenbach K, Retzlik J, Meyer-Rotz SH, Wolff-Menzler C, Wolff J, Esselmann H, Godemann F, Riemenschneider M, Wiltfang J, Jessen F. [Guideline-adherent inpatient psychiatric psychotherapeutic treatment of behavioral and psychological symptoms of dementia : Normative definition of personnel requirements]. Nervenarzt. 2017 Sep;88(9):1010-1019. doi: 10.1007/s00115-016-0195-9. German.
- Background: PubMed 15868348Reggentin H. [Caregiver's burden of caring for patients with dementia in group living compared to to domestic and inpatient care]. Z Gerontol Geriatr. 2005 Apr;38(2):101-7. doi: 10.1007/s00391-005-0295-9. German.
- BackgroundShea, T. (2012). Dementia - Understanding brain diseases and disorders. New York: Rosen Publishing.
- Background: PubMed 12919232van Doorn C, Gruber-Baldini AL, Zimmerman S, Hebel JR, Port CL, Baumgarten M, Quinn CC, Taler G, May C, Magaziner J; Epidemiology of Dementia in Nursing Homes Research Group. Dementia as a risk factor for falls and fall injuries among nursing home residents. J Am Geriatr Soc. 2003 Sep;51(9):1213-8. doi: 10.1046/j.1532-5415.2003.51404.x.
- Background: PubMed 25874613Forbes D, Forbes SC, Blake CM, Thiessen EJ, Forbes S. Exercise programs for people with dementia. Cochrane Database Syst Rev. 2015 Apr 15;2015(4):CD006489. doi: 10.1002/14651858.CD006489.pub4.
- Background: PubMed 24435941Maayan N, Soares-Weiser K, Lee H. Respite care for people with dementia and their carers. Cochrane Database Syst Rev. 2014 Jan 16;2014(1):CD004396. doi: 10.1002/14651858.CD004396.pub3.
- Background: PubMed 15300316Kurz A, Hallauer J, Jansen S, Diehl J. [Efficacy of caregiver support groups for dementia]. Nervenarzt. 2005 Mar;76(3):261-9. doi: 10.1007/s00115-004-1759-7. German.
- Background: PubMed 26718421Heinrich S, Laporte Uribe F, Roes M, Hoffmann W, Thyrian JR, Wolf-Ostermann K, Holle B. Knowledge management in dementia care networks: a qualitative analysis of successful information and support strategies for people with dementia living at home and their family caregivers. Public Health. 2016 Feb;131:40-8. doi: 10.1016/j.puhe.2015.10.021. Epub 2015 Dec 21.
- BackgroundZQP. (2018). Ein Jahr nach letzter Pflegereform: Pflegende Angehörige sehen Informationsbedarf. Retrieved from https://www.presseportal.de/pm/80067/3876592?utm_source=digest&utm_medium=email&utm_campaign=push
- Official Project WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be available based on the informed consent of the participants. Data from the study can be requested from the first author via steffen.heinrich@dzne.de
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard Holle, Dr principal investigator
DZNE Witten
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dementia related mobility and counseling in people with Mobility and Dementia, run by German Center for Neurodegenerative Diseases (DZNE) at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (SPPB) (time frame: 10 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03578861, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2019.