Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AG053675 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
This study aims to test whether a safe physical activity program with a built-in motivational enhancement component, performed in a seated position, preserves the function and well-being of older home care clients.
Regular physical activity benefits older adults physically and mentally. However, the availability and the evidence for physical activity programs that are safe and appropriate for home-bound older adults at risk for nursing home admission are limited. The current project aims to examine the effectiveness of a safe physical activity program, led by home care aides who regularly help hard-to-reach older home care clients with housekeeping and routine personal care services in the home. The primary aim is to test whether the safe physical activity program with a built-in motivational enhancement component, performed in a seated position, preserves the function and well-being of home care clients. The secondary aim is to understand for whom the program is efficacious, the extent to which the program can reach the target population, the extent to which participants drop out of the program, the extent to which program participants maintain the behavioral change introduced by the intervention, and what the program's cost-effectiveness is. Building on a pilot project that demonstrated the program's feasibility in a large home care program funded by the state and Medicaid, this randomized controlled trial will inform future expansion of the physical activity program into real-world home care settings.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Moves | Experimental | Home care aides (HCAs) will be trained to deliver Healthy Moves for Aging Well (Healthy Moves), a gentle physical activity program, to their clients. On the first home care visit after the training, HCAs will introduce the program, assess their clients' readiness for the activity and have their clients set personally meaningful goals, and teach the three chair-bound moves. Home care clients will be asked to do the three moves every day. HCAs remind clients of their activity as part of their regular home care visits throughout the 4-month intervention period. |
|
| Active Mind | Active Comparator | Home care aides (HCAs) will be trained to deliver Active Mind for Aging Well (Active Mind), a gentle thinking activity program, to their clients. On the first home care visit after the training, HCAs will introduce the program, assess their clients' readiness for the activity and have their clients set personally meaningful goals, and teach the activity. Home care clients will be asked to do a word search puzzle every day. HCAs remind clients of their activity as part of their regular home care visits throughout the 4-month intervention period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Moves for Aging Well (Healthy Moves) | Behavioral | A safe physical activity program which consists of a brief motivational enhancement and three movements to be performed in a seated position. The intervention will be delivered by home care aides for their clients. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Function (Daily activity difficulties and dependency in older home care clients) at Month 4 | Activities of daily living that are specifically targeted by the intervention (6-items scale; each task will be scored 0-no difficulty/no help; 1=difficulty but no help; 2=need help; summed score, range 0-12) | Month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Short Physical Performance Battery (SPPB) | Range 0-12 (Guralnik et al., 1994) | Baseline, Month 4, Month 8 |
| Exercise-related social support from home care aides | Frequency of support from home care aides. Three items, range 3-9. Adapted from Sallis et al. (1987) |
| Measure | Description | Time Frame |
|---|---|---|
| Basic activities of daily living (secondary outcome) | 8-item scale; each task will be scored 0-no difficulty/no help; 1=difficulty but no help; 2=need help, summed score range 0-16 (Gill, Robinson, and Tinetti, 1998) | Baseline, Month 4, Month 8 |
| Activities of daily living that are specifically targeted by the intervention (secondary outcome) |
HOME CARE CLIENTS
Inclusion Criteria:
Exclusion Criteria:
HOME CARE AIDES
Inclusion Criteria:
Exclusion Criteria
• Not having a home care client who participates in the study
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Naoko Muramatsu, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60608 | United States |
After the end of the study, data collection instruments, codebooks, and other data documentation will be made available in conjunction with the dataset in a standard format that is readable across a variety of applications. Guidelines from relevant state agencies and collaborators will be followed.
After the publication of the main study results
To protect participants from re-identification while retaining the analytic utility of the data, the data and associated documentation will be available to users only under a data-sharing agreement, managed by the National Archive of Computerized Data on Aging (NACDA), that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Data will only be released once all Institutional Review Board (IRB) approvals and human subjects concerns have been addressed.
Not provided
Not provided
| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| D009043 | Motor Activity |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
Home care aide-client pairs will be randomly assigned to one of two groups in parallel for the duration of the study. Home care aides will not be allowed to have multiple participating clients assigned to different groups to prevent group contamination.
Not provided
Not provided
N/A (there are no other parties who will be masked in the clinical trial)
| Active Mind for Aging Well (Active Mind) | Behavioral | A word puzzle program which consists of a brief motivational enhancement and word search activities. The intervention will be delivered by home care aides for their clients. |
|
| Baseline, Month 4, Month 8 |
| Self-rated health | General self-rated health, range 1-5 (poor to excellent) | Baseline, Month 4, Month 8 |
| Fear of falling | Short Falls Efficacy Scale-International (FES-I), seven items, 4-point scale (not at all worried to very worried), range 7-28 (Kempen et al., 2008). | Baseline, Month 4, Month 8 |
6-item scale; each task will be scored 0-no difficulty/no help; 1=difficulty but no help; 2=need help, summed score range 0-12 |
| Baseline, Month 4, Month 8 |
| Instrumental activities of daily living (secondary outcome) | 4-item scale; each task will be scored 0-no difficulty/no help; 1=difficulty but no help; 2=need help, summed score range 0-8 | Baseline, Month 4, Month 8 |
| Physical activity levels (secondary outcome) | Days and amount of time spent on three types of physical activity in the past week: strengthening, stretching, and aerobics | Baseline, Month 4, Month 8 |
| Falls (secondary outcome) | Number of falls in the past 4 months, and whether any reported falls led to injury that needed medical attention (Yes/No) | Baseline, Month 4, Month 8 |
| Ankle range of motion (secondary outcome) | Angle between ankle dorsiflexion and plantarflexion in degrees | Baseline, Month 4, Month 8 |
| Pain (secondary outcome) | A scale adapted from SF36 to measure pain, after taking pain medication if applicable, range 0-10 | Baseline, Month 4, Month 8 |
| Depressive symptoms (secondary outcome) | Feelings in the past week. 9-item scale (Yes/No), range 0-9 | Baseline, Month 4, Month 8 |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |