Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04628702
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2020-10-28
Brief Title:
Playful Multimodal Intervention Monitoring and Decision Support for Activation of People With Alzheimers Dementia
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
Playful Multimodal Intervention Monitoring and Decision Support for Activation of People With Alzheimers Dementia
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
Recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
M-AAL
Brief Summary:
The worldwide prevalence of dementia is increasing Pharmaceutical therapies at the best slow the degenerative process observable in Alzheimers disease AD Additional approaches are therefore urgently needed to maintain the patients independence and the abilities to execute activities of daily living to reduce the patient specific familial and economic burden Multimodal tablet-based training might be a potential linchpin in this quest The primary aim of this study therefore is to examine the efficacy of the tablet-based training program Multimodal Activation MMA in mild AD patients
In a randomized controlled trial the investigators aim to include 220 mild AD patients of which 110 are randomly assigned to the training group receiving guided tablet-based training for 15 years and 110 to the control group The multimodal intervention as implemented in the training includes physical cognitive and social components Efficacy of the training will be determined by means of between group pre-post comparison in quantitative neuropsychological and qualitative tests MRI biomarker and blood biomarker
In a randomized controlled trial the investigators aim to include 220 mild AD patients of which 110 are randomly assigned to the training group receiving guided tablet-based training for 15 years and 110 to the control group The multimodal intervention as implemented in the training includes physical cognitive and social components Efficacy of the training will be determined by means of between group pre-post comparison in quantitative neuropsychological and qualitative tests MRI biomarker and blood biomarker
Detailed Description:
Background The prevalence of Alzheimers disease is increasing due to an aging society Parallel care and nursing needs and costs rise with disease progression Promoting and stimulating patients to maintain patients abilities and the independent life is therefore essential to prolong the time at home and reduce direct and indirect costs Computer-based technologies such as tablet-based trainings might have the potential to support the patient itself and the caregiver by reducing the nursing care-dependency and stabilizing or slowing the disease progression Prior studies revealed that patients suffering from dementia in general desire technologies supporting cognitive abilities communication skills social integration and activities of daily living eg mobility Lauriks et al 2007 Wand et al 2016 Moreover a multimodal approach has been demonstrated to be superior compared to unimodal approaches aiming to foster only one domain or aspect In this study a multimodal tablet-based training focusing on cognitive psychological physical and aspects of activities of daily living for patients suffering from mild Alzheimers disease was implemented
The primary aim of this study is to examine the efficacy of the multi-domain approach which as implemented in the tablet-based training in mild AD patients Secondary aims are to measures structural and functional cerebral changes quality of life mobility motivation life-style factors stress care-dependency instrumental activities of daily living changes in medical treatments problems in behavior burden due to nursing activity level arm strength depressive symptoms and the usability of the data raised for the development of a decision support system
Methods This study is implemented as a randomized controlled trial with embedded design Two-hundred twenty subjects with mild AD dementia diagnoses according to NINCDS-ADRDA criteria and the primary caregiver will be included in the study One hundred ten subjects will receive a guided tablet-training for 15 years One hundred ten subjects are in the control group receiving normal medical treatment and support Additionally five nursing persons and 5 MAS Morbus Alzheimer syndrome trainers conduct single and group trainings All subjects and the caregivers will be tested and interviewed respectively at study entry at six twelve and eighteen months The study team consist of Joanneum Research JR the Sozialverein Deutschlandsberg SVDL the Austrian Red Cross ÖRK and the Medical University of Graz Department of Neurology and the Institute of Nursing Science as well as Health System Intelligence HSI
Recruiting The recruiting process is carried by telephone flyer home page personal meetings and social media The approach is convenience sampling
Randomisation In advance of the study a randomisation concept determines the participants random assignment to intervention or control group The first half of the 220 participants are 70 likely to be assigned to the intervention group and 30 to the control group For the second half of the sample the likelihood for group assignment reverses This step should guarantee that enough participants receive the intervention in case of challenging recruitment The intervention is favoured over an equal distribution to the groups At the University Clinic of Neurology where the examination takes place only a study nurse knows about the group assignment of the patients forwarding this information to the personnel of the SVDL and the ÖRK
Blinding In the context of the study blinding of the employees of the SVDL and ÖRK is not possible since the intervention is apparent to the personnel The neurologists and neuropsychologists are not informed at any time during the study of the patients group assignment
Intervention Multimodal Activation MMA is an app developed for tablets that contains a serious game and has been previously tested in patients with dementia It stimulates a multimodal training by games that involve cognitive and physical exercises These exercises can be individually adapted to content level of difficulty sequence and time The training starts with physical exercises accompanied by music Afterwards there are cognitive exercises such as a quiz puzzle gap-filling simple arithmetic tasks or listening comprehensions The patients can use MMA at home as well as in a care facility
Intervention group IG The IG undertakes a 15-year tablet PC-based training of cognitive and physical skills using DaheimAktiv which is carried out every 14 days by a MAS trainer medical nurse or pedagogically trained person from the SVDL or the ÖRK together with the patient The tablet remains with the patient at home and the participants are encouraged to continue training without the presence of a trainer with and without a relative All training sessions are recorded DaheimAktiv is a multimodal intervention procedure with cognitive and physical exercises In addition to the fourteen-day training units with the trainers and independent training training cafés will take place in small groups to promote motivation and increase social integration ie several patients train together
Control group CG In the control group the medical interventions initiated are continued standard intervention Apart from that these patients are subjected to the same study conditions as the patients of the intervention group After completion of the evaluation phase patients of the CG will receive a free one-year license for DaheimAktiv
Study outline First a pre-screening of potential participants takes place to check for inclusion and exclusion criteria The patients that fit the criteria are invited to the University Clinic of Neurology for a neurological examination blood sampling also for potential genetic analysis and cognitive assessments performance tests and interviews If a diagnosis of Alzheimers disease is confirmed on a clinical basis patients are invited to a structural and functional magnetic resonance imaging MRI in order to exclude other causes of cognitive deficits and aggregate imaging biomarkers of disease-associated changes such as hippocampal volume Six and twelve months after study inclusion short cognitive testing and interviews at home will be carried out After 15 years the patients from the control and the intervention group again are invited to the University Clinic of Neurology performing the same procedures as during baseline
Hotline For the duration of the study the SVDL provides a hotline specific for questions and problems that participants might face
Statistics The quantitative data will be analysed using IBM SPSS version 250 2017 The chosen level of significance is determined at α 05 Mean and standard deviation or median and quartiles will be part of the descriptive statistics Absolute and relative frequencies will depict categorical data In order to test for the hypothesis regarding the positive effect of tablet training on cognition primary outcome parameters such as global neuropsychological scores as well as secondary variables such as neuropsychological subscores will be compared between intervention and control group using ANCOVA adjusted for multiple testing Furthermore total brain volume local volume of brain areas such as the hippocampus cerebral microstructure and functional connectivity will be measured and compared between groups Other secondary outcome parameters will be analysed using ANCOVA for between group comparisons Pre-post comparisons by ANOVA for repeated measures shall deepen the understanding of how these changes occur over time The analyses will be adjusted for age sex comorbidity and education Qualitative data from the interviews will be organized and coded via the software MAXQDA Afterwards a qualitative content analysis will be applied
Ethics Patients or the person with power of attorney have to give informed consent in order to participate in the study At any given time the participants can refuse or withdraw the consent without giving specific reasons The genetic analysis merely serves a scientific purpose and requires written consent All samples are analysed and stored using pseudonyms Only at the University Clinic of Neurology it is possible to connect the sample with the name of the donor If the results of the genetic analysis will be used for multi-centric research it is ensured that the identity of the donor remains anonymous for cooperating centres All aspects of the examination are non-invasive except blood sampling state-of-the-art procedures that are applied according to the law The ethics committee of the Medical University of Graz approved the study on February 5th 2020 31-556 ex 1819
Data protection Every participant receives an individual pseudonymous code at the University Clinic of Neurology that is shared with the SVDL and ÖRK for patient-code assignment The other partners of the study team only receive the patients code The communication between the project partners and all data transfer occurs using this code to ensure the anonymity of the patients The SVDL submits questionnaires and interviews to the Medical University of Graz MUG via a secured server protected by password All personal information about the participants is confidential Interviews are pseudonymised during transcription The project partners have access to the data for the purpose of data entry and analysis
For the tablet-based training with the MMA app a registration with an email-address and a password is necessary This information is stored in a coded form in a database The serial number of the tablet has to be stored as well Further personal information is optional and hence not required to use the training
The app also stores information about every completed unit in the programme like speed and precision in the training intervention for the sake of future improvement For further analysis of the intervention group the data will be pseudonymous
The usage of fitness trackers only works in combination with an account that the users have to create in the first place However there is no data transfer of the log data to the central database of the project Only the users can access that data
Trainings In order to minimize the inter-rater variability of thr raters for questionnaires and interviews the data-collecting persons of the SVDL and the ÖRK are trained beforehand on the questionnaires and interviews individual interviews focus groups by employees of the MUG Neurology and nursing For the tablet training the SVDL and the ÖRK will train the dementia trainers to use the intervention The duration will be about 4 hours All participantspatients receive training in the application of the intervention by the SVDLÖRK
Hotline contact persons During the study the SVDL will set up a hotline for questions and problems of the participants during the study period Regular times are given for this
The primary aim of this study is to examine the efficacy of the multi-domain approach which as implemented in the tablet-based training in mild AD patients Secondary aims are to measures structural and functional cerebral changes quality of life mobility motivation life-style factors stress care-dependency instrumental activities of daily living changes in medical treatments problems in behavior burden due to nursing activity level arm strength depressive symptoms and the usability of the data raised for the development of a decision support system
Methods This study is implemented as a randomized controlled trial with embedded design Two-hundred twenty subjects with mild AD dementia diagnoses according to NINCDS-ADRDA criteria and the primary caregiver will be included in the study One hundred ten subjects will receive a guided tablet-training for 15 years One hundred ten subjects are in the control group receiving normal medical treatment and support Additionally five nursing persons and 5 MAS Morbus Alzheimer syndrome trainers conduct single and group trainings All subjects and the caregivers will be tested and interviewed respectively at study entry at six twelve and eighteen months The study team consist of Joanneum Research JR the Sozialverein Deutschlandsberg SVDL the Austrian Red Cross ÖRK and the Medical University of Graz Department of Neurology and the Institute of Nursing Science as well as Health System Intelligence HSI
Recruiting The recruiting process is carried by telephone flyer home page personal meetings and social media The approach is convenience sampling
Randomisation In advance of the study a randomisation concept determines the participants random assignment to intervention or control group The first half of the 220 participants are 70 likely to be assigned to the intervention group and 30 to the control group For the second half of the sample the likelihood for group assignment reverses This step should guarantee that enough participants receive the intervention in case of challenging recruitment The intervention is favoured over an equal distribution to the groups At the University Clinic of Neurology where the examination takes place only a study nurse knows about the group assignment of the patients forwarding this information to the personnel of the SVDL and the ÖRK
Blinding In the context of the study blinding of the employees of the SVDL and ÖRK is not possible since the intervention is apparent to the personnel The neurologists and neuropsychologists are not informed at any time during the study of the patients group assignment
Intervention Multimodal Activation MMA is an app developed for tablets that contains a serious game and has been previously tested in patients with dementia It stimulates a multimodal training by games that involve cognitive and physical exercises These exercises can be individually adapted to content level of difficulty sequence and time The training starts with physical exercises accompanied by music Afterwards there are cognitive exercises such as a quiz puzzle gap-filling simple arithmetic tasks or listening comprehensions The patients can use MMA at home as well as in a care facility
Intervention group IG The IG undertakes a 15-year tablet PC-based training of cognitive and physical skills using DaheimAktiv which is carried out every 14 days by a MAS trainer medical nurse or pedagogically trained person from the SVDL or the ÖRK together with the patient The tablet remains with the patient at home and the participants are encouraged to continue training without the presence of a trainer with and without a relative All training sessions are recorded DaheimAktiv is a multimodal intervention procedure with cognitive and physical exercises In addition to the fourteen-day training units with the trainers and independent training training cafés will take place in small groups to promote motivation and increase social integration ie several patients train together
Control group CG In the control group the medical interventions initiated are continued standard intervention Apart from that these patients are subjected to the same study conditions as the patients of the intervention group After completion of the evaluation phase patients of the CG will receive a free one-year license for DaheimAktiv
Study outline First a pre-screening of potential participants takes place to check for inclusion and exclusion criteria The patients that fit the criteria are invited to the University Clinic of Neurology for a neurological examination blood sampling also for potential genetic analysis and cognitive assessments performance tests and interviews If a diagnosis of Alzheimers disease is confirmed on a clinical basis patients are invited to a structural and functional magnetic resonance imaging MRI in order to exclude other causes of cognitive deficits and aggregate imaging biomarkers of disease-associated changes such as hippocampal volume Six and twelve months after study inclusion short cognitive testing and interviews at home will be carried out After 15 years the patients from the control and the intervention group again are invited to the University Clinic of Neurology performing the same procedures as during baseline
Hotline For the duration of the study the SVDL provides a hotline specific for questions and problems that participants might face
Statistics The quantitative data will be analysed using IBM SPSS version 250 2017 The chosen level of significance is determined at α 05 Mean and standard deviation or median and quartiles will be part of the descriptive statistics Absolute and relative frequencies will depict categorical data In order to test for the hypothesis regarding the positive effect of tablet training on cognition primary outcome parameters such as global neuropsychological scores as well as secondary variables such as neuropsychological subscores will be compared between intervention and control group using ANCOVA adjusted for multiple testing Furthermore total brain volume local volume of brain areas such as the hippocampus cerebral microstructure and functional connectivity will be measured and compared between groups Other secondary outcome parameters will be analysed using ANCOVA for between group comparisons Pre-post comparisons by ANOVA for repeated measures shall deepen the understanding of how these changes occur over time The analyses will be adjusted for age sex comorbidity and education Qualitative data from the interviews will be organized and coded via the software MAXQDA Afterwards a qualitative content analysis will be applied
Ethics Patients or the person with power of attorney have to give informed consent in order to participate in the study At any given time the participants can refuse or withdraw the consent without giving specific reasons The genetic analysis merely serves a scientific purpose and requires written consent All samples are analysed and stored using pseudonyms Only at the University Clinic of Neurology it is possible to connect the sample with the name of the donor If the results of the genetic analysis will be used for multi-centric research it is ensured that the identity of the donor remains anonymous for cooperating centres All aspects of the examination are non-invasive except blood sampling state-of-the-art procedures that are applied according to the law The ethics committee of the Medical University of Graz approved the study on February 5th 2020 31-556 ex 1819
Data protection Every participant receives an individual pseudonymous code at the University Clinic of Neurology that is shared with the SVDL and ÖRK for patient-code assignment The other partners of the study team only receive the patients code The communication between the project partners and all data transfer occurs using this code to ensure the anonymity of the patients The SVDL submits questionnaires and interviews to the Medical University of Graz MUG via a secured server protected by password All personal information about the participants is confidential Interviews are pseudonymised during transcription The project partners have access to the data for the purpose of data entry and analysis
For the tablet-based training with the MMA app a registration with an email-address and a password is necessary This information is stored in a coded form in a database The serial number of the tablet has to be stored as well Further personal information is optional and hence not required to use the training
The app also stores information about every completed unit in the programme like speed and precision in the training intervention for the sake of future improvement For further analysis of the intervention group the data will be pseudonymous
The usage of fitness trackers only works in combination with an account that the users have to create in the first place However there is no data transfer of the log data to the central database of the project Only the users can access that data
Trainings In order to minimize the inter-rater variability of thr raters for questionnaires and interviews the data-collecting persons of the SVDL and the ÖRK are trained beforehand on the questionnaires and interviews individual interviews focus groups by employees of the MUG Neurology and nursing For the tablet training the SVDL and the ÖRK will train the dementia trainers to use the intervention The duration will be about 4 hours All participantspatients receive training in the application of the intervention by the SVDLÖRK
Hotline contact persons During the study the SVDL will set up a hotline for questions and problems of the participants during the study period Regular times are given for this
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None