Activate For Life: A Nurse Delivered Hybrid Telehealth/mHealth Aging In Place Intervention To Address Pain And Fatigue In Low-income Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Older Adult Pain Intensity
研究概览
简要总结
The Overall Aim of the present proposal is to evaluate the feasibility of an integrated mind-body intervention, Activate for Life, to improve overall physical activity and mental health and reduce pain and fatigue, resulting in increased likelihood of Aging in Place. Both subjective self-report (i.e., Patient-Reported Outcomes Measurement Information System PROMIS measures of pain, fatigue, depression and anxiety) and objective accelerometer data will be collected, along with standardized measures of balance, strength, and stability. In addition, the measures will be complemented with biomarker-based measures of stress, including cortisol based and 1,5-AG anhydroglucitol assays before, during, and after treatment that are correlated with stress, and fatigue symptoms.
详细描述
The goal of supplement study is to test the feasibility of a self-managed (SM), electronic/mobile Health (e/mHealth) yoga intervention for reducing stress symptoms (burden) in older caregivers (CG) of people with Alzheimer's Disease and related dementia's (PWD). CG burden can exacerbate a myriad of physical and psychosocial comorbidities in CGs as well as PWD neuropsychiatric symptoms. These effects may be further amplified in older CG with underlying health concerns or those who are not able to access programs for effective management of their own medical or self-care needs. Low-impact physical activities such as gentle Yoga (GY) have shown positive effects on mood and symptoms of pain and fatigue in older community dwellers, and digital e/mHealth platforms have a great deal of potential to overcome financial and medical barriers for the delivery SM stress interventions across demographic boundaries. In this study, we will examine the feasibility of a 12-week e/mHealth gentle yoga+yogic breathing (GYYB) intervention for alleviating symptoms of burden in aging CG of PWD (Aim 1); measure initial changes in stress and QoL indicators in CG and PWD (post- vs. pre-intervention) to inform an adequately-powered, future efficacy trial (Aim 2), and; establish a Dyadic Analysis Training Program for Medical University of South Carolina (MUSC) faculty within the College of Nursing and P20 Symptom Self-Management Center (SSMC) to support future research evaluating the influence of care-recipient interactions on health outcomes (Aim 3). Feasibility will be assessed using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, and will include measures such as recruitment, adherence, treatment satisfaction, attrition, and feedback for intervention refinement. Data related to CG physical function, fatigue, depression, social isolation, loneliness, relationship quality, burden, and stress biomarkers, as well as PWD and CG QoL, will be collected via daily electronic practice logs and interviews at study beginning and end. Older (45 yrs. old and older) male and female CG (N=20) of PWD regularly attending respite care (RCC) programs will be recruited from an existing study population (R01 NR016466) participating in CG-RCC mealtime partnerships for improved PWD nutritional outcomes. The HIPAA-compliant GYYB intervention will employ 'tablets' that allow CG to practice GYYB at home by following along with recorded lessons. CG will initially be trained on the use of the tablet and proper GYYB practices by the study coordinator (in-home), with weekly follow up (videoconference/phone) for the duration of the study. This investigation is ideally aligned with the aims of the parent SSMC (P20 NR016575) that are focused on providing infrastructure and community-based resources for design and ecologically-valid testing of self management (SM) interventions for individuals with chronic conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Inability or unwillingness of participant to give informed consent,
- •Physical, cognitive, sensory or psychiatric disability that would limit participants from engaging in self-management program as noted by a Mini-Cog score of 0-
- •Unwillingness to wear a physical activity tracker during the course of the study.
- •Inclusion and Exclusion Criteria for Caregivers (Arm 4)
- •CG must be able to speak and read English
- •CG must be 45 years of age or older
- •CG must be able to provide consent for himself or herself
- •CG must live with or on same property as the PWD
- •CG be primarily responsible for care provision of the PWD in the home (i.e., is not paid for services; provides 4 hours or more of care/day; assists with activities of daily living-ADLs)
- •Exclusion Criteria:
- •CG for whom yoga techniques would be detrimental due to physical limitations,
- •CG who are enrolled in other Yoga-related clinical trials, or who are currently engaged in regular Yoga activity once per week or more.
结局指标
主要结局
Older Adult Pain Intensity
时间窗: Baseline to 12 weeks
Change in mean pain T-scores as measured with the Patient-Reported Outcomes Measurement Information System PROMIS Pain Intensity short form 3a, which allows for individuals to report how much a person hurts. The lowest possible raw score is 4; the highest possible raw score is 20. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the more pain interferes with aspects of one's life compared to the general population. Scores \<55 within normal limits, 55-60 mild, 61-70 moderate, \>70 severe pain intensity.
Older Adult Fatigue
时间窗: Baseline to 12 weeks
Change in mean fatigue T-score as measured by PROMIS Fatigue short form 6a, 6 items that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. The lowest possible raw score is 6; the highest possible raw score is 30. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the worse the fatigue the individual has compared to the general population. Scores \<55 within normal limits, 55-60 mild, 61-70 moderate, \>70 severe fatigue.
Older Adult Pain Behavior
时间窗: Baseline to 12 weeks
Change in mean pain T-score as measured with PROMIS Pain Behavior short form 7a, which allows for self-reported external manifestations of pain: behaviors that typically indicate to others that an individual is experiencing pain. These actions or reactions can be verbal or nonverbal, and involuntary or deliberate. The lowest possible raw score is 7; the highest possible raw score is 42. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the worse or more pain behavior the individual has compared to the general population. Scores \<55 within normal limits, 55-60 mild, 61-70 moderate, \>70 severe pain behavior.
次要结局
- Older Adult Walking Ability(Baseline to 12 weeks)
- Caregiver Depression(Baseline to 12 weeks)
- Older Adult Balance(Baseline to 12 weeks)
- Caregiver Depression CES-D(Baseline to 12 weeks)
- Older Adult Sit-to-Stand Capability(Baseline to 12 weeks)
- Older Adult Depression(Baseline to 12 weeks)
- Older Adult Self Efficacy(Baseline to 12 weeks)
- Caregiver Social Support(12 weeks)
- Older Adult Daily Steps(Baseline to 12 weeks)
- Caregiver Health Status(Baseline to 12 weeks)
- Caregiver Functional Health(Baseline to 12 weeks)
- Caregiver Loneliness(Baseline to 12 weeks)
- Person With Dementia Activities of Daily Living(Baseline to 12 weeks)
- Adherence(End of study at 12 weeks post intervention)
- Older Adult Functional Status(Baseline to 12 weeks)
- Caregiver Anxiety(Baseline to 12 weeks)
- Caregiver Sleep Disturbance(Baseline to 12 weeks)
- Caregiver Burden(Baseline to 12 weeks)
- Caregiver Relationship Quality(Baseline to 12 weeks)
- Caregiver Fatigue(Baseline to 12 weeks)
- Caregiver Quality of Life (QOL)(Baseline to 12 weeks)
- Caregiver of Persons With Dementia Physical Activity(Baseline to 12 weeks)
- Person With Dementia Quality of Life(Baseline to 12 weeks)
- Salivary Cortisol(Baseline to 12 weeks)
- Salivary 1,5-Anhydroglucitol (AG)(Baseline to 12 weeks)
研究者
Teresa Kelechi
Professor
Medical University of South Carolina