Mild Cognitive ImpairmentNCT06149013
Efficacy of MindAhead's Digital Behavioral Activation Therapy in Adults with MCI or Mild Dementia
A study testing MindAhead Active and Treatment-as-usual in people with Mild Cognitive Impairment and Mild Dementia, run by MindAhead UG at 1 site in Germany.
Trial summary
This pilot study investigates effects of a digital behavioral activation therapy in treating patients with mild cognitive impairment and mild dementia, applying a randomized controlled parallel group design. The primary goal is to estimate effect sizes for a larger trial. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Mild Dementia
- What is being tested?
- MindAhead Active and Treatment-as-usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 21 Dec 2023to 31 Oct 2024
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of cognitive impairment in MCI stage (ICD-10 codes: F06.7, F07.8) or mild dementia stage (ICD-10: F00.-*, F01.-, F03) due to all etiologies apart from etiologies described in F02.- (Pick's disease, Parkinson's disease, multiple sclerosis, Huntington's disease, HIV, Lewy body disease). Hence, etiologies of MCI and mild dementia include
- Alzheimer's disease (e.g., F00.-*)
- Vascular disease (e.g., F01.-) (exception in case of stroke: event occurred > 12 months ago without ongoing spontaneous remission)
- Mixed diseases
- Unclear etiologies
- MCI or mild dementia diagnosis assigned within the last 12 months by a neurologist or psychiatrist from our cooperation partners that fulfil adequate diagnosis procedures such as neuropsychological assessment, brain imaging, self- and/or third-party medical history interview, and potentially cerebrospinal fluid, positron emission tomography, or electrophysiological measures
Show all 12Show fewer
- MCI or mild dementia diagnosis confirmed by a treating physician
- MMSE ≥ 24 or MoCA ≥ 18 (last date of assessment is decisive; needs to be within the last 12 months)
- Sufficient physical fitness to engage in physical activities (e.g., walking or cycling) as confirmed by a treating physician
- Age ≥ 50
- German language skills sufficient to understand German instructions of study assessments and of the intervention
- Ability and sufficient vision to operate a smartphone
Who cannot join
- possibly moderate or severe cognitive impairment (moderate or severe dementia), indicated by MMSE < 24 or MoCA < 18 (last date of assessment is decisive; needs to be within the last 12 months)
- Specific brain injury events within the last 12 months or with ongoing spontaneous remission due to
- Stroke (ischemic, hemorrhagic)
- Traumatic brain injury
- Specific etiologies of MCI or mild dementia (F02.-) that show a variable course or a fast progression including
- Multiple sclerosis
Show all 13Show fewer
- Parkinson's disease
- Pick's disease / Frontotemporal lobar degeneration
- Lewy body disease
- Brain tumors
- Autosomal dominant form of Alzheimer's disease with early first manifestation
- Creutzfeldt-Jakob disease
- German language restrictions or visual restrictions which prevent from understanding written German instructions of assessment or intervention procedures (e.g. severe aphasia, lack of sufficient German language skills, severe non-corrected visual impairment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of MindAhead's Digital Behavioral Activation Therapy in Adults with Mild Cognitive Impairment or Mild Dementia: a Monocentric Randomized Controlled Pilot Trial (MindMoments-Pilot)
This pilot study investigates effects of a digital behavioral activation therapy in treating patients with mild cognitive impairment and mild dementia, applying a randomized controlled parallel group design. The primary goal is to estimate effect sizes for a larger trial. A further aim is to investigate the feasibility of study procedures and to validate new questionnaire scores. Primary outcomes are the change in the patients' quality of life and in their overall activity level.
Read the detailed description
Face-to-face behavioral activation therapy focusing on meaningful and enjoyable, physical, cognitive and social activities has shown positive effects on quality of life and activity level as well as long-term benefits on cognition and daily functioning in patients with MCI and mild dementia. In addition, effects on neuropsychiatric symptoms such as depression are reasonable as behavioral activation therapy has strong and consistent effects on patients with depression. However, effects of a highly scalable, digital version of behavioral activation therapy in patients with MCI or mild dementia are not proven so far. Therefore, this study primarily aims to explore effects of the digital health app MindAhead Active in adults with MCI or mild dementia in a pilot study.
The primary objective of this study is to explore effect sizes in different outcomes (primary outcomes: quality of life, overall activity level) that will be used to calculate the sample size of a larger trial. The secondary objective is the validation of instruments. The investigators aim to validate three questionnaires that may depict outcomes of the full-scale study in case of success.
Further objectives are to assess feasibility regarding the study (recruitment of eligible subjects, online assessment, study completion/dropout rates), and the intervention (app installation, usage and intervention adherence/completion) as well as to confirm findings from previously conducted studies on face-to-face behavioral activation therapy reporting no safety issues and no increase in adverse events in contrast to a control group. This trial is a monocentric, randomized controlled, assessor-blinded superiority trial with two parallel groups.
- Conditions
- Mild Cognitive Impairment, Mild Dementia
- Being tested
- MindAhead Active, Treatment-as-usual
- Keywords
- Behavioral Activation Therapy, Active lifestyle intervention
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindAhead ActiveDevice
Also called MindAhead's Behavioral Activation Therapy
MindAhead's Active app focuses on increasing meaningful and enjoyable cognitive, physical, and social activities specifically adapted to patients with early cognitive decline (MCI or mild dementia). These techniques include psychoeducation (explaining the rationale, the components of behavioral activation, and protective activities), action planning (selecting activities, goal setting, activity scheduling, graded task assignment, written schedules, and step-by-step sequencing) and action/self-monitoring (assessing execution of and enjoyment in activities, monitor mood and cognitive problems), as well as value-based activation (understanding most important values, selecting activities according to these values). This process aims to enable the users to understand which activities are enjoyable and meaningful to them and how to implement these activities into their daily lives. MindAhead's Active app consists of one to five sessions per week.
Treatment-as-usualOther
Also called TAU
Depending on patient-specific clinical findings it includes antidementive medication (e.g., acetylcholinesterase inhibitors), advice on protective lifestyle factors, vitamin supplementation, ergotherapy, cognitive training (including digital health apps), or statins.
| Study group | Role | What they receive |
|---|---|---|
| MindAhead + TAU Group | Experimental | The intervention group receives the digital health app MindAhead Active for 3 months as well as treatment-as-usual (TAU, see Control intervention). Receives: Device: MindAhead Active; Other: Treatment-as-usual |
| TAU Group | Active comparator | The control group receives TAU which may include antidementive medication (e.g., acetylcholinesterase inhibitors), advice on protective lifestyle factors, vitamin supplementation, ergotherapy, cognitive training (including digital health apps), or statins depending on clinical findings. Receives: Other: Treatment-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Quality of Life
Change in quality of life (total score of generic and disorder-specific quality of life) from baseline to 3-month follow-up. Overall quality of life will be measured with a composite score of all items of the World Health Organization WHOQOL-BREF quality of life assessment and the Dementia Quality of Life (DEMQOL). All items will be transformed to a scale ranging from 0 to 100 and subsequently averaged. Higher scores indicate a higher quality of life.
Measured: 3 months
Activity Level
Change in activity level (total score of social, physical and cognitive activity level) from baseline to 3-month follow-up. Overall activity level will be measured with the Community Healthy Activities Model Program for Seniors (CHAMPS) German version. The CHAMPS assesses frequency and duration of 41 physical, cognitive, and social activities of a typical week within the last 4 weeks. As measure for activity level, we assess the total hours spend per week covering all performed 41 activities, by adding up the data on activity duration (as described by Poelke, et al., 2016, International Psychogeriatrics). Therefore, the duration scale for each item is transformed as described in the original work by Stewart et al. (2001, Medicine and Science in Sports and Exercise), with category 1 = 0.5 hours, 2 = 1.75 hours, 3 = 3.75 hours, 4 = 5.75 hours, 5 = 7.75 hours, and 6 = 9.75 hours. The composite score can range from 0 to 399.75 hours per week.
Measured: 3 months
Secondary outcomes (17)
Disorder-specific quality of life
Change in disorder-specific quality of life from baseline to 3-month follow-up. Disorder-specific quality of life will be measured with the Dementia Quality of Life (DEMQOL) questionnaire. The DEMQOL contains 29 items with one overall quality of life item as well as 28 specific items covering positive and negative emotions, cognition and acitivities of daily living. For the total score the 28 specific items are used (scores ranging from 28 to 112, with higher scores indicating higher quality of life).
Measured: 3 months
Generic quality of life - composite score
Change in generic quality of life from baseline to 3-month follow-up. Generic quality of life - composite score will be measured with the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL-BREF total score is composed by the 26 items of all 4 WHOQOL-BREF subdomains (raw scores ranging from 26 to 130 are transformed to range from 0 to 100, with a higher score indicating higher quallity of life).
Measured: 3 months
Generic quality of life - physical health subscale
Change from baseline to 3-month follow-up. Generic quality of life - physical health will be measured with the World Health Organization WHOQOL-BREF quality of life assessment - physical health subscale with 7 items (raw scores ranging from 7 to 35 are transformed to range from 0 to 100, with a higher score indicating higher physical health).
Measured: 3 months
Generic quality of life - psychological health subscale
Change from baseline to 3-month follow-up. Generic quality of life - psychological health will be measured with the World Health Organization WHOQOL-BREF quality of life assessment - psychological health subscale with 6 items (raw scores ranging from 6 to 30 are transformed to range from 0 to 100, with a higher score indicating higher psychological health).
Measured: 3 months
Generic quality of life - social relationships subscale
Change from baseline to 3-month follow-up. Generic quality of life - social relationships will be measured with the World Health Organization WHOQOL-BREF quality of life assessment - social relationships subscale with 3 items (raw scores ranging from 3 to 15 are transformed to range from 0 to 100, with a higher score indicating higher quality of social relationships).
Measured: 3 months
Generic quality of life - environment subscale
Change from baseline to 3-month follow-up. Generic quality of life - environment will be measured with the World Health Organization WHOQOL-BREF quality of life assessment - environment subscale with 8 items (raw scores ranging from 8 to 40 are transformed to range from 0 to 100, with a higher score indicating higher environmental quality of life).
Measured: 3 months
Generic quality of life - global subscale
Change from baseline to 3-month follow-up. Generic quality of life - environment will be measured with the World Health Organization WHOQOL-BREF quality of life assessment - global subscale with 2 items (raw scores ranging from 2 to 10 are transformed to range from 0 to 100, with a higher score indicating higher global quality of life).
Measured: 3 months
Cognitive activity level
Change in cognitive activity level from baseline to 3-month follow-up. Cognitive activity levels will be measured with CHAMPS.
The activities will be categorized to the three domains (physical, cognitive, and social activity level as described in Küster et al., 2016, BMC Psychiatry). The following activities are included in the cognitive domain: single-domain activities: play muscial instruments; use a computer; read; do arts and crafts; and multidomain acitivities: play basketball, soccer or raquetball; play singles tennis; play doubles tennis; dance; play cards and board games; visit family or friends; do volunteer work; attend club meetings; attend cultural meetings; do yoga or Tai Chi.
The cognitive activity level domain score is then built as described in Poelke, et al. (2016, International Psychogeriatrics).
Measured: 3 months
Physical activity level
Change in physical activity level from baseline to 3-month follow-up. Physical activity levels will be measured with the CHAMPS.
The activities will be categorized to the three domains (physical, cognitive, and social activity level as described in Küster et al., 2016, BMC Psychiatry). The following activities are included in the physical domain: single-domain activities: jog or run; swim moderately or fast; skate; use an aerobic machine; do moderate/heavy strength training; walk uphill or hike; do heavy gardening; do water exercise; bicycle; do heavy work around the house; and multidomain acitivities: play basketball, soccer or raquetball; play singles tennis; play doubles tennis; dance; do yoga or Ta Chi; do aerobic; play golf with carrying equipment.
The physical activity level domain score is then built as described in Poelke, et al. (2016, International Psychogeriatrics).
Measured: 3 months
Social activity level
Change in social activity level from baseline to 3-month follow-up. Social activity levels will be measured with the CHAMPS.
The activities will be categorized to the three domains (physical, cognitive, and social activity level as described in Küster et al., 2016, BMC Psychiatry). The following activities are included in the social domain: single-domain activities: go to the senior center; attend curch activities; and multidomain acitivities: play basketball, soccer or raquetball; play singles tennis; play doubles tennis; dance; play cards and board games; visit family or friends; do volunteer work; attend club meetings; attend cultural events; do aerobic; play golf with carrying equipment.
The social activity level domain score is then built as described in Poelke, et al. (2016, International Psychogeriatrics).
Measured: 3 months
Depressive symptoms
Change in depressive symptoms from baseline to 3-month follow-up. Depressive symptoms will be measured with the Geriatric Depression Scale 30 (GDS-30). The GDS contains 30 items (scores range from 0 to 30 with higher scores indicating greater depression).
Measured: 3 months
Subjective cognitive symptoms - everyday memory
Change in subjective cognitive symptoms from baseline to 3-month follow-up. Subjective cognitive symptoms will be measured with the Everyday Memory Survey (EMS). The EMS contains 25 items of which 23 items are included into the total score (scores range from 0 to 92, with higher scores indicating greater subjective cognitive symptoms - everyday memory).
Measured: 3 months
Subjective cognitive symptoms - global cognition
Change in subjective cognitive symptoms from baseline to 3-month follow-up. Subjective cognitive symptoms - global cognition will be measured with a new German version of the British Columbia - Cognitive Complaints Inventory (BC-CCI). The BC-CCI contains 6 items (scores range from 0 to 18, with higher scores indication greater subjective cognitive complaints).
Measured: 3 months
Chronic disease-specific quality of life
Change in chronic disease-specific quality of life from baseline to 3-month follow-up, measured with the German Quality of Life Scale (QOLS-G). The QOLS-G contains 16 items which are summed up to a sum score (scores range from 16 to 112, with higher scores indicating higher level of satisfaction).
Measured: 3 months
Neurocognitive disorder-specific quality of life
Change in neurocognitive disorder-specific quality of life from baseline to 3-month follow-up, measured with the newly developed Quality of Life-Neurocognitive Disorder (QoL-NCD), which is based on the Mild Cognitive Impairment Questionnaire and the Dementia Quality of Life (DEMQOL)-self report. The QoL-NCD contains 25 items, with a superordinate item on general quality of life and 6 items for each of the 4 domains: cognitive health, psychological health, activities of daily living, and social relationships. The total score includes all 25 items (range from 0 to 100 with higher scores indication higher quality of life).
Measured: 3 months
Goal-oriented activity level
Change in goal-oriented activity level from baseline to 3-month follow-up. Goal-oriented activity level will be measured with the activation subscale of the Behavioral Activation for Depression Scale (BADS). The BADS Activation subscale contains 7 items (scores range from 0 to 42, with higher scores indicating a higher goal-oriented activity level).
Measured: 3 months
Domain-specific activity level
Change in domain-specific activity level from baseline to 3-month follow-up. Domain-specific activity level will be measured with the newly developed Meaningful, Enjoyable, Physical, Social, and Cognitive Activity Scale (MEPSCAS). The MEPSCAS contains of 5 items, assessing physical, cognitive, social, enjoyable and meaningful activity on a 10-point rating scale from 1 ("not at all") to 10 ("extremely"). The domain-specific activity level composite scores will be built by averaging all available items, thus ranging from 1 to 10, with higher scores depicting higher domain-specific activity.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start21 Dec 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- MindAhead UG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Medical Center Göttingen
- Responsible party
- Sponsor
- Investigators
- Jens Wiltfang, Prof. Dr., Principal investigator, University Medical Center Göttingen, Clinic for Psychiatry and Psychotherapy, GermanyChristine A.F. von Arnim, Prof. Dr., Principal investigator, University Medical Center Göttingen, Clinic for Geriatrics, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149013
- Sponsor's protocol ID
- MiMo-P
- Status last verified
- Nov 2024
- First submitted
- 9 Nov 2023
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of MindAhead's Digital Behavioral Activation Therapy in Adults with Mild Cognitive Impairment or Mild Dementia: a Monocentric Randomized Controlled Pilot Trial (MindMoments-Pilot)
- ClinicalTrials.gov ID
- NCT06149013
- Acronym / sponsor ID
- MiMo-P
- Conditions
- Mild Cognitive Impairment, Mild Dementia
- Keywords
- Behavioral Activation Therapy, Active lifestyle intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- MindAhead UGIndustry (pharma, biotech, devices)
- Collaborators
- University Medical Center Göttingen
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 28 Nov 2023 (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.
This pilot study investigates effects of a digital behavioral activation therapy in treating patients with mild cognitive impairment and mild dementia, applying a randomized controlled parallel group design. The primary goal is to estimate effect sizes for a larger trial. A further aim is to investigate the feasibility of study procedures and to validate new questionnaire scores. Primary outcomes are the change in the patients' quality of life and in their overall activity level.
Detailed description
Face-to-face behavioral activation therapy focusing on meaningful and enjoyable, physical, cognitive and social activities has shown positive effects on quality of life and activity level as well as long-term benefits on cognition and daily functioning in patients with MCI and mild dementia. In addition, effects on neuropsychiatric symptoms such as depression are reasonable as behavioral activation therapy has strong and consistent effects on patients with depression. However, effects of a highly scalable, digital version of behavioral activation therapy in patients with MCI or mild dementia are not proven so far. Therefore, this study primarily aims to explore effects of the digital health app MindAhead Active in adults with MCI or mild dementia in a pilot study.
The primary objective of this study is to explore effect sizes in different outcomes (primary outcomes: quality of life, overall activity level) that will be used to calculate the sample size of a larger trial. The secondary objective is the validation of instruments. The investigators aim to validate three questionnaires that may depict outcomes of the full-scale study in case of success.
Further objectives are to assess feasibility regarding the study (recruitment of eligible subjects, online assessment, study completion/dropout rates), and the intervention (app installation, usage and intervention adherence/completion) as well as to confirm findings from previously conducted studies on face-to-face behavioral activation therapy reporting no safety issues and no increase in adverse events in contrast to a control group. This trial is a monocentric, randomized controlled, assessor-blinded superiority trial with two parallel groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MindAhead + TAU Group | Experimental | Device: MindAhead Active, Other: Treatment-as-usualThe intervention group receives the digital health app MindAhead Active for 3 months as well as treatment-as-usual (TAU, see Control intervention). |
| TAU Group | Active comparator | Other: Treatment-as-usualThe control group receives TAU which may include antidementive medication (e.g., acetylcholinesterase inhibitors), advice on protective lifestyle factors, vitamin supplementation, ergotherapy, cognitive training (including digital health apps), or statins depending on clinical findings. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of cognitive impairment in MCI stage (ICD-10 codes: F06.7, F07.8) or mild dementia stage (ICD-10: F00.-*, F01.-, F03) due to all etiologies apart from etiologies described in F02.- (Pick's disease, Parkinson's disease, multiple sclerosis, Huntington's disease, HIV, Lewy body disease). Hence, etiologies of MCI and mild dementia include
- MCI or mild dementia diagnosis assigned within the last 12 months by a neurologist or psychiatrist from our cooperation partners that fulfil adequate diagnosis procedures such as neuropsychological assessment, brain imaging, self- and/or third-party medical history interview, and potentially cerebrospinal fluid, positron emission tomography, or electrophysiological measures
- MCI or mild dementia diagnosis confirmed by a treating physician
- MMSE ≥ 24 or MoCA ≥ 18 (last date of assessment is decisive; needs to be within the last 12 months)
- Sufficient physical fitness to engage in physical activities (e.g., walking or cycling) as confirmed by a treating physician
Key exclusion criteria (13 listed)
- possibly moderate or severe cognitive impairment (moderate or severe dementia), indicated by MMSE < 24 or MoCA < 18 (last date of assessment is decisive; needs to be within the last 12 months)
- Specific brain injury events within the last 12 months or with ongoing spontaneous remission due to
- Specific etiologies of MCI or mild dementia (F02.-) that show a variable course or a fast progression including
- German language restrictions or visual restrictions which prevent from understanding written German instructions of assessment or intervention procedures (e.g. severe aphasia, lack of sufficient German language skills, severe non-corrected visual impairment)
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 |
|---|---|---|
| MindAhead ActiveAlso: MindAhead's Behavioral Activation TherapyMindAhead's Active app focuses on increasing meaningful and enjoyable cognitive, physical, and social activities specifically adapted to patients with early cognitive decline (MCI or mild dementia). These techniques include psychoeducation (explaining the rationale, the components of behavioral activation, and protective activities), action planning (selecting activities, goal setting, activity scheduling, graded task assignment, written schedules, and step-by-step sequencing) and action/self-monitoring (assessing execution of and enjoyment in activities, monitor mood and cognitive problems), as well as value-based activation (understanding most important values, selecting activities according to these values). This process aims to enable the users to understand which activities are enjoyable and meaningful to them and how to implement these activities into their daily lives. MindAhead's Active app consists of one to five sessions per week. | Device | MindAhead + TAU Group |
| Treatment-as-usualAlso: TAUDepending on patient-specific clinical findings it includes antidementive medication (e.g., acetylcholinesterase inhibitors), advice on protective lifestyle factors, vitamin supplementation, ergotherapy, cognitive training (including digital health apps), or statins. | Other | MindAhead + TAU Group, TAU Group |
Primary outcome
Overall Quality of Life
Time frame: 3 months
Change in quality of life (total score of generic and disorder-specific quality of life) from baseline to 3-month follow-up. Overall quality of life will be measured with a composite score of all items of the World Health Organization WHOQOL-BREF quality of life assessment and the Dementia Quality of Life (DEMQOL). All items will be transformed to a scale ranging from 0 to 100 and subsequently averaged. Higher scores indicate a higher quality of life.
Activity Level
Time frame: 3 months
Change in activity level (total score of social, physical and cognitive activity level) from baseline to 3-month follow-up. Overall activity level will be measured with the Community Healthy Activities Model Program for Seniors (CHAMPS) German version. The CHAMPS assesses frequency and duration of 41 physical, cognitive, and social activities of a typical week within the last 4 weeks. As measure for activity level, we assess the total hours spend per week covering all performed 41 activities, by adding up the data on activity duration (as described by Poelke, et al., 2016, International Psychogeriatrics). Therefore, the duration scale for each item is transformed as described in the original work by Stewart et al. (2001, Medicine and Science in Sports and Exercise), with category 1 = 0.5 hours, 2 = 1.75 hours, 3 = 3.75 hours, 4 = 5.75 hours, 5 = 7.75 hours, and 6 = 9.75 hours. The composite score can range from 0 to 399.75 hours per week.
17 secondary outcomes
Disorder-specific quality of life
Time frame: 3 months
Generic quality of life - composite score
Time frame: 3 months
Generic quality of life - physical health subscale
Time frame: 3 months
Generic quality of life - psychological health subscale
Time frame: 3 months
Generic quality of life - social relationships subscale
Time frame: 3 months
Generic quality of life - environment subscale
Time frame: 3 months
Generic quality of life - global subscale
Time frame: 3 months
Cognitive activity level
Time frame: 3 months
Physical activity level
Time frame: 3 months
Social activity level
Time frame: 3 months
Depressive symptoms
Time frame: 3 months
Subjective cognitive symptoms - everyday memory
Time frame: 3 months
Subjective cognitive symptoms - global cognition
Time frame: 3 months
Chronic disease-specific quality of life
Time frame: 3 months
Neurocognitive disorder-specific quality of life
Time frame: 3 months
Goal-oriented activity level
Time frame: 3 months
Domain-specific activity level
Time frame: 3 months
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 13 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
Jens Wiltfang, Prof. Dr. principal investigator
University Medical Center Göttingen, Clinic for Psychiatry and Psychotherapy, Germany
Christine A.F. von Arnim, Prof. Dr. principal investigator
University Medical Center Göttingen, Clinic for Geriatrics, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MindAhead Active and Treatment-as-usual in people with Mild Cognitive Impairment and Mild Dementia, run by MindAhead UG 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 12 inclusion and 13 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 13 Nov 2024. 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?
Overall Quality of Life (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2024.