Activate For Life: mHealth Intervention To Address Pain And Fatigue In Low-income Older Adults Aging In Place

NCT ID: NCT03853148

Last Updated: 2022-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-06
• Study Completion Date: 2022-05-25

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.

Conditions

Pain, Chronic; Fatigue Syndrome, Chronic; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Otago

The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level.

Group Type: ACTIVE_COMPARATOR

Otago

Intervention Type: BEHAVIORAL

Exercise program for strength and balance

Otago + Gentle yogic breathing

The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits.

Group Type: ACTIVE_COMPARATOR

Otago

Intervention Type: BEHAVIORAL

Exercise program for strength and balance

Gentle yogic breathing

Intervention Type: BEHAVIORAL

yogic breathing

Otago + GYYB + Behavioral activation

This condition will incorporate Otago and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days.

Group Type: ACTIVE_COMPARATOR

Otago

Intervention Type: BEHAVIORAL

Exercise program for strength and balance

Gentle yogic breathing

Intervention Type: BEHAVIORAL

yogic breathing

Behavioral Activation

Intervention Type: BEHAVIORAL

Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.

Caregiver Gentle yoga & yogic breathing

The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits.

Group Type: EXPERIMENTAL

Caregiver Gentle yogic breathing

Intervention Type: BEHAVIORAL

yogic breathing

Interventions

Otago

Exercise program for strength and balance

Intervention Type: BEHAVIORAL

Gentle yogic breathing

yogic breathing

Intervention Type: BEHAVIORAL

Behavioral Activation

Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.

Intervention Type: BEHAVIORAL

Caregiver Gentle yogic breathing

yogic breathing

Intervention Type: BEHAVIORAL

Other Intervention Names

GYYB; Caregiver GYYB

Eligibility Criteria

Exclusion Criteria

• 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.

• 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.

• 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)

• 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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Teresa Kelechi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

College of Nursing Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

References

Kelechi TJ, Layne D, Mueller M, Madisetti M, Balasubramanian S. Feasibility and Preliminary Impact of a Web-Based Mind Body Intervention for Older Dementia Caregivers. West J Nurs Res. 2024 Jun;46(6):416-427. doi: 10.1177/01939459241247926. Epub 2024 Apr 24.

Reference Type: DERIVED

PMID: 38655852 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35148798 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5P20NR016575-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pr00076835

Identifier Type: -

Identifier Source: org_study_id