Digitally Supported Lifestyle Programme to Promote Brain Health Among Older Adults
NCT05565170, Not applicable, Completed, Finnish Institute for Health and Welfare
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Digitally Supported Lifestyle Programme to Promote Brain Health Among Older Adults | ClinicalTrials.gov |
| NCT number | NCT05565170 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 156 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Finnish Institute for Health and Welfare | ClinicalTrials.gov |
| Conditions | Cognitive Impairment, Cognitive Decline, Dementia | ClinicalTrials.gov |
| Interventions | Structured ICT-assisted multimodal lifestyle intervention, Self-guided multimodal lifestyle intervention | ClinicalTrials.gov |
| First posted | 2022-10-04 | ClinicalTrials.gov |
| Last updated | 2026-05-26 | ClinicalTrials.gov |
Registered outcomes 39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Feasibility: retention rate | 24 months | Percentage of participants completing the 24-month trial period in each study arm. Higher percentage indicates a better outcome. | ClinicalTrials.gov |
| Primary | Feasibility: adherence to the structured multimodal lifestyle intervention | Continuously measured during 24 months | Attendance at scheduled intervention sessions (percentage), usage of / engagement with the digital devices (LETHE App, Fitbit smartwatch). Possible values range from a minimum of 0, with higher values indicating better adherence and more active engagement. | ClinicalTrials.gov |
| Primary | Change in dementia risk scores (LIBRA and CAIDE), units on a scale | Baseline, 12 months, 24 months | Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) risk score and Change in the LIfestyle for BRAin health (LIBRA) score are validated tools to estimate late-life dementia risk based on a combination of non-modifiable and modifiable risk factors (CAIDE) or modifiable factors only (LIBRA). Total score ranges from 0 to 15 (CAIDE) and from -5.9 to +12.7 (LIBRA). Higher scores indicate higher risk. | ClinicalTrials.gov |
| Secondary | Change in healthy lifestyle, unit on a scale | Baseline, 12 months, 24 months | Change in Healthy Lifestyle Index (brief score developed in the FINGER trial), a composite score based on self-reported data on exercise, diet, vascular factors, and cognitive/social activity (range 0-24, with a higher score indicating a better outcome) | ClinicalTrials.gov |
| Secondary | Change in cognition: composite z-score based on an extended Neuropsychological Test Battery (NTB), unit on a scale | Baseline, 12 months, 24 months | The NTB used in this study is adapted from the FINGER trial and includes the following tests: * Wechsler Memory Scale Revised, WMS-III, WMS-R, logical memory, immediate * WMS-R logical memory, delayed * WMS-R visual paired associates, immediate * WMS-R visual paired associates, delayed * WMS-R Digit Span, total * Rey Auditory Verbal Learning Test, RAVLT, learning (free recall) * RAVLT, delayed recall * CERAD category fluency * Category fluency (fruits and vegetables) * Trail Making Test (TMT) A * Trail Making Test (TMT) B, shifting score B-A * Stroop Test, shortened 40-stimulus version, condition 2 * Stroop Test, condition 3, interference score 3 - 2 * Wechsler Adult Intelligence Scale (WAIS) Digit Symbol Substitution Test (DSST) Higher z-score indicates better outcome (better cognitive performance). | ClinicalTrials.gov |
| Secondary | Change in stress-related symptoms (Perceived Stress Scale, PSS-14), unit on a scale | Baseline, 12 months, 24 months | PSS is a 14-item self-report scale assessing stress-related symptoms. Values ranging 0-56, with lower scores indicating a better outcome. | ClinicalTrials.gov |
| Secondary | Change in sleep problems (Insomnia Severity Index, ISI), unit on a scale | Baseline, 12 months, 24 months | The Insomnia Severity Index (ISI) is a validated seven item assessment tool to assist in the clinical evaluation of insomnia complaints. Values ranging 0-28, with lower scores indicating a better outcome. | ClinicalTrials.gov |
| Secondary | Change in health-related quality of life (RAND-36), unit on a scale | Baseline, 12 months, 24 months | The RAND-36 is comprised of 36 items that assess eight health concepts. The scale values are ranging 0-100, with higher scores indicating a better outcome. | ClinicalTrials.gov |
| Secondary | Change in health literacy (short version of the European Health Literacy Survey Questionnaire, HLS-EU-Q16), unit on a scale. | Baseline, 24 months | Health literacy will be assessed with the 16-item short version of the European Health Literacy Survey Questionnaire. Each item has four response categories (very difficult, fairly difficult, fairly easy and very easy), and higher scores indicate better health literacy. | ClinicalTrials.gov |
| Other | Exploratory: Change in physical activity - self-reported, unit on a scale | Baseline, 12 months, 24 months | Self-reported physical exercise in the previous two weeks, using a modified version of the Minnesota Leisure Time Physical Activity Questionnaire, as number of sessions and average duration for each of the activities listed in the questionnaire. Higher levels of physical activity indicate a better outcome. Self-reported number of sessions of moderate-to-vigorous intensity exercise per week. A higher number of sessions indicates a better outcome. | ClinicalTrials.gov |
| Other | Exploratory: Change in physical activity - objective, based on Fitbit smartwatch | Continuously for 24 months | Objective measurement of physical activity levels, e.g., step count, using the Fitbit smartwatch which is worn continuously throughout the trial. Higher values indicate a better outcome. | ClinicalTrials.gov |
| Other | Exploratory: Change in dietary intake, unit on a scale | Baseline, 12 months, 24 months | A brief food frequency questionnaire is used to calculate scores reflecting adherence to a healthy diet (MEDAS score reflecting adherence to Mediterranean-type diet; Healthy Diet Index score developed in Finland in the context of FINGER and type 2 diabetes prevention studies). Higher scores indicate a better outcome. | ClinicalTrials.gov |
| Other | Exploratory: Change in individual cognitive domains, unit on a scale | Baseline, 12 months, 24 months | Composite z-scores for the: * memory * executive function * processing speed domains that are included in the NTB used as a measure for the primary outcome. | ClinicalTrials.gov |
| Other | Exploratory: Change in cognition based on the digital assessment of cognitive performance (cCOG), unit on a scale | 1 month, 13 months, 25 months (approx. 1 month after each main study visit and NTB assessment) | cCOG is a web-based self-administrable cognitive testing tool with three classical cognitive tasks: a modification of word list test, simple reaction task, and TMT. Higher scores and quicker performance indicate a better outcome. | ClinicalTrials.gov |
| Other | Exploratory: Change in global cognition/function: Clinical Dementia Rating Sum of Boxes (CDR-SB), unit on a scale | Baseline, 24 months | CDR and CDR Sum of Boxes (CDR-SB) scores are used to assess the influence of cognitive impairment on the ability to conduct everyday activities in patients with Alzheimer's disease and give a global clinical impression of the patient. CDR-SB Score values range from 0-18, with lower scores indicating better outcome. | ClinicalTrials.gov |
| Other | Exploratory: Change in functioning level: Instrumental Activities of Daily Living (IADL), unit on a scale | Baseline, 12 months, 24 months | Activity of Daily Living, Lawton-Brody Scale. Self-reported questionnaire assessing the level of functioning in eight daily activities necessary for living in the community. For each activity, the participant is rated either dependent (0 points) or independent (1 point). The score ranges 0-8, with a higher score indicating a better outcome. | ClinicalTrials.gov |
| Other | Exploratory: Change in blood pressure, mmHg | Baseline, 6 months, 12 months, 24 months | Changes in systolic and diastolic blood pressure, lower measurements indicate better outcomes | ClinicalTrials.gov |
| Other | Exploratory: Change in Body Mass Index (BMI), kg/m² | Baseline, 6 months, 12 months, 24 months | Calculated using baseline height, with lower BMI value indicating better outcome | ClinicalTrials.gov |
| Other | Exploratory: Change in waist circumference, cm | Baseline, 6 months, 12 months, 24 months | Lower waist circumference value indicating a better outcome | ClinicalTrials.gov |
| Other | Exploratory: Change in concentration of blood lipids - total cholesterol, mmol/l | Baseline, 6 months, 12 months, 24 months | Measured from serum, a lower total cholesterol value indicates a better outcome. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 39574193 | RESULT | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 8
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Category Fluency | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Short Story Recall | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)