Clinical trial NCT03853148: Activate For Life: mHealth Intervention To Address Pain And Fatigue In Low-income Older Adults Aging In Place
Official title: Activate For Life: A Nurse Delivered Hybrid Telehealth/mHealth Aging In Place Intervention To Address Pain And Fatigue In Low-income Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Fatigue Syndrome, Chronic
Aging
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Nursing Research (NINR)
First posted: 2019-02-25
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion and Exclusion Criteria for Older Adults (Arms 1, 2, 3):

* Males and females older adults 60 years of age and older living in a Humanities Foundation apartment complex or in their own homes
* PROMIS pain interference score of eight or above and/or a PROMIS pain behavior score of 15 or above (for older adults)
* Able to ambulate 150 feet with or without the use of an assistive device
* Able to follow simple instructions
* Able to read, speak, and write English,
* Able to operate tablet device and wearable activity tracker,
* Not currently enrolled in an exercise program.

Exclusion Criteria:

* 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 0-2.
* 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.

Primary outcomes:
measure: Older Adult Pain Intensity
timeFrame: Baseline to 12 weeks
measure: Older Adult Fatigue
timeFrame: Baseline to 12 weeks
measure: Older Adult Pain Behavior
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Older Adult Functional Status
timeFrame: Baseline to 12 weeks
measure: Older Adult Balance
timeFrame: Baseline to 12 weeks
measure: Older Adult Sit-to-Stand Capability
timeFrame: Baseline to 12 weeks
measure: Older Adult Walking Ability
timeFrame: Baseline to 12 weeks
measure: Older Adult Depression
timeFrame: Baseline to 12 weeks
measure: Older Adult Self Efficacy
timeFrame: Baseline to 12 weeks
measure: Older Adult Daily Steps
timeFrame: Baseline to 12 weeks
measure: Caregiver Anxiety
timeFrame: Baseline to 12 weeks
measure: Caregiver Health Status
timeFrame: Baseline to 12 weeks
measure: Caregiver Functional Health
timeFrame: Baseline to 12 weeks
measure: Caregiver Sleep Disturbance
timeFrame: Baseline to 12 weeks
measure: Caregiver Depression
timeFrame: Baseline to 12 weeks
measure: Caregiver Depression CES-D
timeFrame: Baseline to 12 weeks
measure: Caregiver Fatigue
timeFrame: Baseline to 12 weeks
measure: Caregiver Loneliness
timeFrame: Baseline to 12 weeks
measure: Caregiver Social Support
timeFrame: 12 weeks
measure: Caregiver Burden
timeFrame: Baseline to 12 weeks
measure: Caregiver Quality of Life (QOL)
timeFrame: Baseline to 12 weeks
measure: Caregiver Relationship Quality
timeFrame: Baseline to 12 weeks
measure: Person With Dementia Quality of Life
timeFrame: Baseline to 12 weeks
measure: Person With Dementia Activities of Daily Living
timeFrame: Baseline to 12 weeks
measure: Caregiver of Persons With Dementia Physical Activity
timeFrame: Baseline to 12 weeks
measure: Salivary Cortisol
timeFrame: Baseline to 12 weeks
measure: Salivary 1,5-Anhydroglucitol (AG)
timeFrame: Baseline to 12 weeks
measure: Adherence
timeFrame: End of study at 12 weeks post intervention
Other outcomes:
Locations:
city: Charleston
country: United States
facility: College of Nursing Medical University of South Carolina
state: South Carolina
Study officials:
References:
citation: Hernandez-Tejada MA, Nagel A, Madisetti M, Balasubramanian S, Kelechi T. Feasibility trial of an integrated treatment "Activate for Life" for physical and mental well-being in older adults. Pilot Feasibility Stud. 2022 Feb 11;8(1):38. doi: 10.1186/s40814-022-01000-8.