Action for Positive Brain Health Now: Ready, Set, Go
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- Change in physical activity
研究概览
简要总结
HIV (human immunodeficiency virus) can have subtle but important effects on the brain, leading to difficulties in memory, concentration, or problem solving. Goal-setting interventions have been shown to help individuals maintain their physical activity in order to improve brain health. The study objective is to estimate the extent to which goal management training before a personalized healthy lifestyle program is associated with greater adherence to health recommendations, achievement of health-related goals, and better brain health and general health outcomes compared to the healthy lifestyle program alone. Participants will be randomized to either Goal Management Training (GMT) and a Healthy Lifestyle Program (HLP) or the control group (HLP alone).
详细描述
Based on healthy aging research in HIV- populations, it is already known that many older people living with HIV could protect or improve their brain health through lifestyle change . However, no intervention is effective if it is not done. Sustained lifestyle change is hard for everyone, but expected to be harder still for those with a chronic condition that affects cognitive ability, eroding the very executive functions needed for effective goal-directed behavior. Thus, the key question is not whether interventions will help brain health in HIV but rather how we can improve adherence to the most promising interventions in people experiencing brain health challenges.
This study will test an innovative approach to enhance adherence to lifestyle interventions, building on feasibility evidence from pilot trials in the Brain Health Now (BHN) study. Goal Management Training (GMT) is a fully manualized cognitive rehabilitation program delivered over 9 weeks in small groups. It targets executive dysfunction, teaching self-management and mindfulness. GMT also trains participants to use explicit strategies to reduce cognitive load in everyday tasks, and methods to cue attention to maintain focus on specific tasks, through weekly 2-h sessions and practice at home. We hypothesize that GMT priming before a personalized Healthy Lifestyle Program (HLP) will improve adherence to that program and subsequently improve health outcomes, compared to the HLP without GMT priming, in cognitively frail men and women living with HIV.
Study objectives
The overall objective of Action for Brain Health Now is to understand, empower and act to protect and improve brain health in HIV, in order to empower patients to take charge of their brain health. This sub-study is directed to the third aim, act. This proposed study addresses the real-world challenge of implementing tailored recommendations, recognizing that the cognitively frail individuals who would benefit the most from lifestyle changes are least equipped to successfully adopt and sustain healthy behaviours. We will trial a novel cognitive rehabilitation approach using goal-management training to boost adherence to a tailored active living intervention.
Specific objective
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV+ for at least 1 year
- •Able to communicate adequately in either French or English
- •Able to give written informed consent
- •One or more indicators of cognitive frailty (B-CAM<20, C3Q <60%) OR those that do not meet the criteria of successful aging (<7 subscales of SF-36 ≥Canadian Norms)
排除标准
- •Dementia (MSK-rating stage 3 or more-cognitive component only
- •Life expectancy < 3 years or other personal factor limiting the ability to participate in follow-up
- •Non-HIV-related neurological disorder likely to affect cognition
- •Known active CNS opportunistic infection or hepatitis C requiring IFN treatment during the follow-up period
- •Known psychotic disorder
- •Current substance dependence or abuse within the past 12 months
- •People who have a medical contraindication to moderate exercise (walking for 10 minutes)
结局指标
主要结局
Change in physical activity
时间窗: 0 and 12 months
Number of weeks in which physical activity guidelines are met (150 min of moderate to vigorous activity in bouts of 10 minutes)
Change in social activity
时间窗: 0 and 12 months
Number of weeks in which at least one organized social activity was attended
次要结局
- Change in fatigue(0 and 12 months)
- Change in quality of life(0 and 12 months)
- Change in sleep(0 and 12 months)
- Change in distress(0 and 12 months)
- Change in goal attainment(0 and 12 months)
- Change in general health perception(0 and 12 months)
- Change in pain(0 and 12 months)
- Change in depression(0 and 12 months)
- Change in physical Activity pattern(0 and 12 months)
- Change in anxiety(0 and 12 months)
研究者
Nancy Mayo
Nancy Mayo, Principal Investigator
McGill University