Digital Solution for Salutogenic Brain Health (DiSaB): A Pilot Sequential Multiple Assignment Randomised Trial (SMART) Protocol for Clinical Implementation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change in heart rate
研究概览
简要总结
The goal of this clinical trial is to develop and learn if a digitally delivered brain health intervention (DiSaB) can help improve cognitive, physical and psychosocial health in middle-aged adults with chronic conditions at-risk for cognitive decline. The clinical trial also aims to find out the push and pull factors of implementing the intervention in primary care settings. The main questions it aims to answer are:
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Does the DiSaB intervention improve participants' cognitive functions, health measures, and psychosocial health?
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Is an individualised or group-based health education session better at improving cognitive, physical and psychosocial health in participants who did not respond to the DiSaB intervention?
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How useful and practical is the DiSaB intervention, according to
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participants and
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nurses carrying out the intervention?
The investigators will compare a DiSaB intervention to a control condition (where participants do not undergo any intervention) to see if the DiSaB intervention works in improving participants' health.
The investigators will also compare individualised versus group health education sessions to see which session is better at improving the health of participants who did not respond to the DiSaB intervention.
Participants will
- Complete cognitive assessments, questionnaires, and health tests before intervention, immediately after the intervention, and 6 months after the intervention
- Either undergo no intervention, or undergo the DiSaB intervention over 2 months
- Be randomly selected to attend focus group interviews
Local champions will complete questionnaires and attend focus group interviews after administering and/or co-facilitating the intervention.
详细描述
The effectiveness of the DiSaB intervention implementation at primary care setting amongst participants with long term conditions will be evaluated using the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) model.
Secondly, the barriers and facilitators to DiSaB implementation amongst local champions [e.g., advanced practice nurses (APNs)] will be determined. Specifically, using the Capability, Opportunity, Motivation and Behavior (COM-B) model, the investigators will evaluate the barriers and facilitators towards DiSaB intervention implementation among healthcare professionals.
Third, sequential multiple assignment randomised trial (SMART) study design will also be employed in this study for the development of dynamic treatment regimens (DTRs) tailored for individual needs. The investigators first aim to evaluate the feasibility and compare the efficacy of additional individual intervention (i.e. a health education individual feedback session within 1 - 2 months) vs a smaller group intervention (i.e. health education group sessions over 3 months, once per month) post-standard TYB intervention amongst non-responders, in improving cognitive functions and management of their long-term conditions. Finally, the investigators will compare two embedded DTRs in the SMART, namely, (1) standard TYB followed by individualised health education session for non-responders and usual care for responders, and (2) standard TYB followed by group health education session for non-responders and usual care for responders.
Lastly, an economic evaluation will be carried out to evaluate cost-effectiveness and further impacts of the DiSaB implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None (Participant)
入排标准
- 年龄范围
- 40 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 40 - 55 years old
- •Have hypertension, hyperlipidaemia and/or type-2 diabetes
- •Ability to provide written informed consent
- •Posses sufficient English language skills in reading, writing and speaking
- •Multimorbidity conditions are also acceptable with the exception of life-threatening co-morbidities with life expectancy of less than one year
- •Total Risk Score (TRS) for cognitive impairment of at least 3
排除标准
- •Physical, visual and/or hearing impairment
- •Language impairment (i.e. severe dysarthria or aphasia)
- •Not within age range listed
- •Major or active psychiatric conditions
- •Diagnosis of dementia
- •Do not own a mobile device capable of downloading applications (i.e. Zoom), and/or do not have access to internet connection
结局指标
主要结局
Change in heart rate
时间窗: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; months 9/12)
Heart rate will be measured on-site
Change in lipid levels
时间窗: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; months 9/12)
Information will be obtained from patients; HealthHub/Health Buddy/OneNUHS or other health apps
Change in HbA1c levels
时间窗: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Information will be obtained from patients; HealthHub/Health Buddy/OneNUHS or other health apps
Change in blood pressure
时间窗: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Blood pressure will be measured on-site
Change in SDMT scores
时间窗: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Symbol Digit Modality Test (SDMT). Total maximum score is 110. Higher scores indicate better cognitive performance.
Change in psychosocial health measured by DaSS-21
时间窗: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Depression, Anxiety and Stress Scale -21 item (DASS-21) Physical or online. There are 21 questions that are scored from 0 to 3, and the highest possible score is 63. Higher scores indicate poorer psychological health.
Change in MoCA scores
时间窗: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Montreal Cognitive Assessment (MoCA). Total possible score is 30 (scoring is on the MoCA form itself), and a score of at least 26 indicates normal cognition. Higher scores indicate better cognition.
Change in quality of life measured by EQ-5D-5L
时间窗: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Physical or online. Each question is scored from 1 to 5, with 1 indicating no problems in that dimension and 5 indicating total inability to perform in that dimension.
Patient satisfaction feedback questionnaire (patients)
时间窗: Weekly (right after each TYB intervention) for 2 months. Also after health education sessions: either once [individual session] OR monthly for 3 months [group session]; during months 4-6) - intervention arm non-responders only
Completed online
Feedback from patients using focus group interview
时间窗: Final follow up (month 9/12)
Questions are developed from RE-AIM model. Participants will be randomly chosen (n=30) to take part in the focus group interview.
Change in psychosocial health measured by AD8
时间窗: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Alzheimer's Disease-8 Component (AD8) Physical or online. There are a total of 8 questions asking about thinking ability, and each answer is coded 1 (yes, change present) or 0 (no change). 0 or 1 indicates normal cognition, and a score of at least 2 suggests that cognition issues might be present.
Change in psychosocial health measured by Self-care of chronic illness inventory
时间窗: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Physical or online. 29 questions in total, answers are scored from 1 to 5. Higher scores indicate better self-care. When referencing standard scores, a standard score of 70 is the cut-off point for self-care adequacy.
Effectiveness of TYB intervention questionnaire (nurses)
时间窗: Weekly for 2 months (after each TYB intervention - months 1-3 for intervention arm and months 4-6 for control arm), final follow up (month 12)
Using RE-AIM model; completed online. Questionnaire will be given at multiple time points throughout the study, as listed below.
Effectiveness of DiSaB intervention questionnaire (patients)
时间窗: Once at the end of TYB intervention (month 3 for intervention arm, month 6 for control arm), once during final follow-up (month 9/12 for all participants)
Using RE-AIM model; completed online. Questionnaire is given at multiple points throughout the study, as listed below.
Feedback from nurses using focus group interview
时间窗: Month 6 (immediately after completion of 2-month-long TYB intervention control arm)
Questions are developed from RE-AIM model
次要结局
- Economic evaluation on the feasibility of DiSaB implementation using cost-effectiveness questionnaire(Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; months 9/12))
研究者
Catherine Yanhong Dong, PhD
Assistant Professor
National University of Singapore