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O estudo clínico NCT05934136 para Memory Loss (Excluding Dementia), Estilo de vida saudável, Comportamento de redução de risco está ativo, não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Brain Health Program for Older Adults with Subjective Cognitive Decline
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT05934136 é um ensaio intervencionista para Memory Loss (Excluding Dementia), Estilo de vida saudável, Comportamento de redução de risco. Seu status atual é: ativo, não recrutando. O estudo começou em 16 de janeiro de 2024 e pretende incluir 60 participantes. Coordenado por Massachusetts General Hospital e deve ser concluído em 1 de novembro de 2025. Essas informações foram atualizadas no ClinicalTrials.gov em 21 de fevereiro de 2025.
Resumo
The investigators will compare two brain health programs in older adults with subjective cognitive decline and lifestyle risk factors for dementia. The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the programs.
Descrição detalhada
The investigators aim to promote brain health by reducing lifestyle risk factors for dementia in older adults with subjective cognitive decline (SCD). This study is a pilot randomized control trial (RCT) comparing two virtual lifestyle programs, My Healthy Brain 1 and My Healthy Brain 2. Eligible older adults include: age ≥ 60, self-reported worry about changes in memory or thinking, and risk factors for dementia (determined by the Cardiovascular Risk Factors, Aging, and Incidence of Dementia score ≥ 6). Participants will be randomized to one of two groups (My Healthy Brain 1 or My Healthy Brain 2) and will complete 8 weekly 90-minute sessions via Zoom delivered by a clinical psychologist. Each session will focus on a different topic relevant to brain health (e.g. physical activity, sleep, etc.). The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the programs. The investigators will also explore improvements in cognition, lifestyle behaviors (physical activity, sleep, nutrition, alcohol and tobacco use, social functioning), depression, anxiety, and mindfulness assessed at baseline, post-intervention, and 6 month follow-up. All participants will wear a watch to monitor changes in lifestyle during the program.
Título oficial
My Healthy Brain: a Group-Based Lifestyle Intervention to Modify Early Risk of Dementia in Older Adults
Condições
Memory Loss (Excluding Dementia)Estilo de vida saudávelComportamento de redução de riscoPublicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:- Mace RA, Hopkins SW, Reynolds GO, Vranceanu AM. My Healthy Brain: Rationale and Case Report of a Virtual Group Lifestyle Program Targeting Modifiable Risk Factors for Dementia. J Clin Psychol Med Settings. 2022 Dec;29(4):818-830. doi: 10.1007/s10880-022-09843-2. Epub 2022 Jan 25.
- Mace RA, Greenberg J, Stauder M, Reynolds G, Vranceanu AM. My Healthy Brain: a multimodal lifestyle program to promote brain health. Aging Ment Health. 2022 May;26(5):980-991. doi: 10.1080/13607863.2021.1904828. Epub 2021 Mar 30.
- Mace RA, Popok PJ, Hopkins SW, Fishbein NS, Vranceanu AM. Adaptation and virtual feasibility pilot of a mindfulness-based lifestyle program targeting modifiable dementia risk factors in older adults. Aging Ment Health. 2023 Apr;27(4):695-707. doi: 10.1080/13607863.2022.2032600. Epub 2022 Feb 1.
- Mace RA, Law ME, Cohen JE, Ritchie CS, Okereke OI, Hoeppner BB, Brewer JA, Bartels SJ, Vranceanu AM; My Healthy Brain Team. A Mindfulness-Based Lifestyle Intervention for Dementia Risk Reduction: Protocol for the My Healthy Brain Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2024 Nov 21;13:e64149. doi: 10.2196/64149.
Outros IDs do estudo
- 2023P001770
Número NCT
Data de início (real)
2024-01-16
Última atualização postada
2025-02-21
Data de conclusão (estimada)
2025-11-01
Inscrição (estimada)
60
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ativo, não recrutando
Propósito principal
Prevenção
Alocação do design
Randomizado
Modelo de intervenção
Atribuição paralela
Cegamento (Mascaramento)
Simples-cego
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalMy Healthy Brain 1 My Healthy Brain 1 is an 8-week group program delivered via 90-minute Zoom meetings led by a clinical psychologist. It provides education on the link between dementia and lifestyle factors, including poor exercise, sleep, diet/nutrition, mental and social stimulation, alcohol, and smoking. My Healthy Brain 1 participants learn evidence-based mindfulness and behavior change skills to address common barriers to healthy habits, such as stress and setting achievable goals. My Healthy Brain 1 participants wear an activity watch to monitor lifestyle changes during the program. | MY Healthy Brain 1 My Healthy Brain 1 is an 8-week group program delivered via 90-minute Zoom meetings led by a clinical psychologist. It provides education on the link between dementia and lifestyle factors, including poor exercise, sleep, diet/nutrition, mental and social stimulation, alcohol, and smoking. My Healthy Brain 1 participants learn evidence-based mindfulness and behavior change skills to address common barriers to healthy habits, such as stress and setting achievable goals. My Healthy Brain 1 participants wear an activity watch to monitor lifestyle changes during the program. |
Comparador ativoMy Healthy Brain 2 My Healthy Brain 2 condition controls for the effect of time spent and support/feedback from the group and interventionist. Participants in My Healthy Brain 2 will receive education on lifestyle, brain health, and cognitive decline symptoms in addition to usual care as determined by their medical team. Each weekly session will focus on a different topic: 1) lifestyle and brain health, 2) physical activity, 3) sleep, 4) nutrition, 5) medical adherence, 6) cognitive health, 7) social support, and 8) a program overview. My Healthy Brain 2 is conducted in the same format as My Healthy Brain 1 (8 weekly Zoom sessions, 90 minutes each), but does not include behavior change strategies. My Healthy Brain 2 participants wear an activity watch to monitor lifestyle changes during the program. | MY Healthy Brain 2 My Healthy Brain 2 condition controls for the effect of time spent and support/feedback from the group and interventionist. Participants in My Healthy Brain 2 will receive education on lifestyle, brain health, and cognitive decline symptoms in addition to usual care as determined by their medical team. Each weekly session will focus on a different topic: 1) lifestyle and brain health, 2) physical activity, 3) sleep, 4) nutrition, 5) medical adherence, 6) cognitive health, 7) social support, and 8) a program overview. My Healthy Brain 2 is conducted in the same format as My Healthy Brain 1 (8 weekly Zoom sessions, 90 minutes each), but does not include behavior change strategies. My Healthy Brain 2 participants wear an activity watch to monitor lifestyle changes during the program. |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Credibility and Expectancy Questionnaire | Assesses how believable, convincing, and logical patients perceive the treatment to be. Higher scores (min = 3, max = 27) scores indicate greater credibility and expectancy. | 0 Weeks |
Client Satisfaction Questionnaire | Assesses patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction. | 8 Weeks |
Rates of Recruitment and Enrollment | We will assess the feasibility of recruiting and enrolling participants into the study by calculating the proportion who agree to participate divided by the total number contacted (≥70% good, ≥ 80% excellent). | 0 Weeks |
Rates of Missing Outcomes Data | We will assess the feasibility of data collection by calculating the proportion of secondary outcomes (cognition and lifestyle) with no missing data divided by the total number collected (≥70% good, ≥ 80% excellent). | 8 Weeks |
Rates of Valid Activity Watch Data (10 or more hours of wear time) | We will assess the feasibility of collecting valid activity watch data by calculating the proportion of participants who wore the watch at least 5 out of 7 days per week for at least 10 or more hours per day, divided by the total number of days in the program (≥ 70% good, ≥ 80% excellent). | 8 Weeks |
Rates of Ecological Momentary Assessment (EMA) Data | We will assess the feasibility of collecting ecological momentary assessment (EMA) of daily mindfulness practice by calculating the proportion of participants who complete at least 5 out of 7 daily surveys per week (≥ 70% good, ≥ 80% excellent). | 8 Weeks |
Rates of Treatment Completion | We will assess the acceptability of treatment by calculating the proportion of participants who attend ≥ 6/8 treatment sessions (≥ 70% good, ≥ 80% excellent). | 8 Weeks |
Rates of Therapist Fidelity to Intervention Procedures | We will assess the fidelity of therapists to the intervention procedures by calculating the proportion of sessions with completed audio recordings, progress notes, and checklist with 100% of content delivered divided by the total number of sessions (≥ 75% good, 100% excellent). | 8 Weeks |
Rates of Staff Fidelity to Study Procedures | We will assess the fidelity of staff to the study procedures by counting the frequency of protocol deviations (\<5 deviations good, 0 deviations excellent). | 8 Weeks |
Modified Patient Global Impression of Change at 8 weeks | The proportion of participants who report perceived improvements in cognitive function, lifestyle, and emotional well-being outcomes (1=Very Much Worse, 7=Very Much Improved). | 8 Weeks |
Rate of Adverse Events | We will assess the safety of the study by founding the number and severity of adverse events (mild in ≤ 10% of participants = good, none = excellent). | 8 Weeks |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | A comprehensive test of five cognitive domains (immediate memory, visuospatial/constructional, language, attention, and delayed memory) and global cognition. Higher Z and Index Scores indicate greater cognitive functioning on each domain. | 0 Weeks, 8 Weeks, 6 Months |
Cognitive Function Instrument | 14-item self-report of cognitive and functional status. Higher total scores (min=0, max=14) indicate greater subjective cognitive complaints. | 0 Weeks, 8 Weeks, 6 Months |
Change in Step Count | Activity watch change in steps count during the 7 days preceding baseline assessment, throughout the intervention period, and 7 days at 6-month follow-up. Higher step count totals indicate greater physical activity (walking). | 0 Weeks, 8 Weeks, 6 Months |
PROMIS Physical Function | 8-item self-report of daily functioning. Higher T scores (mean = 50, sd = 10) indicate greater physical function. | 0 Weeks, 8 Weeks, 6 Months |
Change in Total Sleep Time | Activity watch change in total sleep time during the 7 days preceding baseline assessment, throughout the intervention period, and 7 days at 6-month follow-up. Higher total minutes indicate greater sleep time. | 0 Weeks, 8 Weeks, 6 Months |
Pittsburgh Sleep Quality Index | 9-item self-report of sleep patterns and overall quality. Higher total scores (min=0, max=21) indicate greater sleep disturbance (\>5 = clinically significant). | 0 Weeks, 8 Weeks, 6 Months |
Mediterranean Eating Pattern for Americans Screener | 16-item self-report of adherence to Mediterranean dietary recommendations. Higher total scores (min=0, max=21) indicate greater intake/adherence of Mediterranean foods. | 0 Weeks, 8 Weeks, 6 Months |
PROMIS Alcohol Use | 7-item self-report of at-risk drinking. Higher T scores (mean = 50, sd = 10) indicate greater problematic alcohol use. | 0 Weeks, 8 Weeks, 6 Months |
CDC Other Tobacco Product Use Questions | 2-item self-report of the frequency and use of 6 common tobacco products (1=Less than once a month, 5=Daily or almost daily). | 0 Weeks, 8 Weeks, 6 Months |
PROMIS Satisfaction with Social Roles and Activities | 8-item self-report measure of satisfaction of performing usual social roles and activities. Higher T scores (mean = 50, sd = 10) indicate greater satisfaction with social roles and activities. | 0 Weeks, 8 Weeks, 6 Months |
Critérios de elegibilidade
Idades elegíveis
Adulto, Adulto mais velho
Idade mínima
60 Years
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim
- Concerns about memory or thinking (subjective cognitive decline, SCD) aged 60 or older
- Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) ≥ 6
- Telephone Interview for Cognitive Status-41 ≥ 31
- Functional Assessment Questionnaire < 9
- English fluency/literacy
- Ability and willingness to participate via live video
- No self-reported safety issues with initiating lifestyle changes during the study
- Mild cognitive impairment, dementia, or neurodegenerative disease
- Psychotropic medications (e.g., antidepressant) change in the last 3 months
- Psychosis, uncontrolled bipolar disorder or substance dependence; schizophrenia or schizoaffective disorder
- Current self-report of suicidal ideation
- Serious medical illness expected to worsen in 6 months (e.g., cancer)
- Use of digital monitoring device (e.g., Fitbit) in the last 3 moths AND unwillingness to stop using personal digital monitoring device for duration of program
- Mindfulness or mind-body practice (> 45 min/wk) focused on lifestyle, cognitive-behavioral therapy in < 3 months, or participation in a lifestyle prevention program (ex: diabetes prevention) in < 3 months
- Average daily step count > 5,000 steps
- More than 30 minutes of exercise daily
Massachusetts General HospitalResponsável pelo estudo
Ryan A., Mace, PHD, Investigador principal, Staff Psychologist, Massachusetts General Hospital
Sem dados de contato.
1 Locais do estudo em 1 países
Massachusetts
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States