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| ID | Type | Description | Link |
|---|---|---|---|
| 1P30AG086561-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The goal of this clinical trial is to learn the effects of technology enhancements when combined with basic education, goal-setting, and self-monitoring to increase physical activity among older adults living alone, experiencing subjective cognitive decline, and currently engaging minimal physical activity (60 minutes or less of moderate to vigorous physical activity). Further, we will examine key psychosocial mechanisms believed to contribute to successful promotion of physical activity, which include social support and stress resilience.
The primary questions are to determine whether
All participants will engage in self-monitoring of physical activity, will receive weekly text reminders of their physical activity goals for the week, and will receive basic education about the importance of physical activity, social support, and stress resilience for cognitive, physical, and psychological health. Participants in the tech-enhanced condition will also receive access to a study-specific website and virtual coaching to reinforce the information presented. Researchers will then compare the tech-enhanced condition to the basic education condition to determine the benefits of technology to deliver the intervention materials in order to increase physical activity, social support, and stress resilience.
Participants will:
The sample has several risk factors for Alzheimer's disease and related dementias: low physical activity, social isolation risk via living alone, and subjective cognitive impairment. Therefore, a long-term goal includes the determination of the intervention's effectiveness at increasing physical activity, social support, and stress resilience to reduce risk for developing dementia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tech-enhanced condition | Experimental | Participants in the tech-enhanced condition will receive access to a study specific website (to be developed into an app) and guided use via individual coaching sessions delivered on Zoom. Coaching sessions will align with and reinforce website content, which includes information about the importance of and strategies to increase physical activity, social support, and stress resilience. |
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| Control condition | Active Comparator | Participants in the control condition will receive a study-specific manual containing basic education about the importance of and strategies to increase physical activity, social support, and stress resilience. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-monitoring | Behavioral | All participants will receive a Garmin and use the associated app to monitor their weekly physical activity. Enrolled participants are insufficiently active (engaging in 60 minutes or less of moderate to vigorous physical activity per week) and will receive weekly text messages to incrementally increase physical activity over the course of the study. Goals will be 20% greater than the average daily steps from the previous week, with the ultimate goal of reaching 7000 average daily steps. 7000 average daily steps was selected based on recent findings that it is associated with clinically meaningful health outcomes and being an achievable target for most adults. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical activity as measured by average daily steps (and minutes of moderate to vigorous physical activity) from baseline to 3-months | ActiGraph GT9X Link Activity monitors worn on non-dominant wrist during waking hours 7 consecutive days will provide objective measure of 1) average daily steps and 2) moderate to vigorous activity prior to and after the intervention. GTX9X data (collected in raw format) will be aggregated for analysis to epochs of 60 secs or less for comparability to other studies. | Assessed at baseline and 3-months |
| Change in self-reported physical activity | Participants will complete an abbreviated 7-Day Physical Activity Recall interview, which assesses self-reported moderate to vigorous physical activity. | Assessed at baseline and 3-months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Stress Resilience | At baseline and 3 months, participants will have blood drawn to assess glial fibrillary acidic protein, an indicator of stress which has also been associated with neurocognitive disorders. | Assessed at baseline and 3-months |
| Self-reported stress |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Health | To establish eligibility, participants will complete the Telephone administered Montreal Cognitive Assessment (T-MoCA) during the online eligibility screening. Because we are recruiting individuals with subjective cognitive decline, we will rule out potential cognitive impairment with the T-MoCA. Scores are totaled. Possible scores range from 0 to 22. Higher scores indicating better performance. Participants scoring 17 or lower (out of 22) will be ineligible for participation. We will readminister at the end of the 3 month intervention to determine whether change occurred. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Molly Maxfield, PhD | Contact | 602-496-2311 | Molly.Maxfield@asu.edu | |
| Rodney Joseph, PhD | Contact | 602-496-0772 | Rodney.Joseph@asu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Molly Maxfield | Arizona State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University | Recruiting | Phoenix | Arizona | 85004 | United States |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015190 | Blood Glucose Self-Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
The 14-item Perceived Stress Scale, with items rated on a 5 point scale (0 to 4). Sum scores are calculated. Possible values range from minimum of 0 to maximum of 56. Higher scores indicate greater perceived stress. |
| Assessed at baseline, end of month 1, end of month 2, and end of month 3 |
| Brief Resilience Scale | The 6-item Brief Resilience Scale assesses ability to recover from or adjust to challenges. Items are rated on a 5 point scale. Mean scores are calculated. Possible scores range from a minimum of 1 to a maximum of 5. Higher scores indicating greater resilience. | Assessed at baseline, end of month 1, end of month 2, and end of month 3 |
| Social Isolation | The 10-item Lubben Social Network Scale assesses objective size of social network. Items are rated on a 6 point scale. Sum scores are calculated. Possible scores range from a minimum of 0 and maximum of 60. Higher scores indicate larger social network and contacts. | Assessed at baseline, end of month 1, end of month 2, and end of month 3 |
| Self-reported loneliness | The 3-item UCLA Loneliness scale assesses the feeling of being alone or lacking companionship. Responses range from 1 to 3. Sum scores are calculated. Possible scores range from a minimum of 3 to a maximum of 9. Higher numbers indicate greater perceived loneliness. | Assessed at baseline, end of month 1, end of month 2, and end of month 3 |
| Depression | Participants will complete the 15-item Geriatric Depression Scale. The items include yes/no responses. Scores will be summed. Possible scores range from a minimum value of 0 to a maximum value of 15. Higher scores indicate greater depression. At eligibility screening, participants must score below 9 on this measure to be included in the study. | Assessed at screening and after the 3 month intervention |
| General Anxiety | Participants will complete the 7-item General Anxiety Disorder Questionnaire. Using a 4 point scale (0 to 3), the items assess worry and anxiety over the past two weeks. Mean scores will be calculated. Possible scores range from a minimum score of 0 to a maximum score of 21. Higher scores indicate greater anxiety. | Assessed at baseline and after the 3 month intervention |
| Health-related quality of life | Participants will complete the 4-item health-related quality of life assessment. The items assess self-perceived health and days during the past month they had poor physical health or mental health, and the extent to which poor health kept them from doing daily activities. Mean scores will be calculated. Higher scores indicate poorer health-related quality of life. | Assessed at baseline and after the 3 month intervention |
| Assessed during online eligibility screening and after the 3 month intervention |
| Change in Garmin-assessed physical activity | Participants agree to wear a Garmin throughout the study, offering continuous data about their physical activity. We will use average daily steps (calculated weekly, from Monday to Sunday) to assess physical activity continuously during the intervention. | From enrollment to the end of treatment at 3 months |
| Subjective Cognitive Decline | Participants will complete the 20-item Subjective Cognitive Decline questionnaire. They will rate the level of change on a 5 point scale (no change to much worse). Mean scores will be calculated, with higher scores indicating greater perceived decline in cognitive functioning. | Assessed at baseline and after the 3 month intervention |
| Objective cognitive functioning: Processing Speed 2 | Participants will complete two tasks assessing processing speed. The second requires matching of patterns between numbers and symbols as quickly as possible without making mistakes. This is the Oral Symbol Digit Task from the NIH Toolbox Cognitive Battery. Scoring is automatically calculated by the NIH Toolbox App and is age normed, with higher scores indicating stronger performance on the task. | Assessed at baseline and after the 3 month intervention |
| Objective cognitive functioning: Processing Speed 1 | Participants will complete two tasks assessing processing speed. The first requires visual processing of patterns in two pictures, detecting similarities and differences as quickly as possible without making mistakes. This is the Pattern Comparison Task from the NIH Toolbox Cognitive Battery. Scoring is automatically calculated by the NIH Toolbox App and is age normed, with higher scores indicating stronger performance on the task. | Assessed at baseline and after the 3 month intervention |
| Objective cognitive functioning: Executive functioning | Participants will complete an executive functioning task requiring set-shifting, or the ability to switch back and forth between multiple aspects of a strategy or task. This is the Dimensional Change Card Sort Task from the NIH Toolbox Cognitive Battery. Scoring is automatically calculated by the NIH Toolbox App and is age normed, with higher scores indicating stronger performance on the task. | Assessed at baseline and after the 3 month intervention |
| Objective cognitive functioning: Verbal memory | Participants will complete a verbal memory task in which they hear a series of words read and are asked to recall as many as they can immediately after the list; this process is completed three times total to assess both learning and memory. Ten to 15 minutes later, they are asked to recall as many words as possible. This is the Auditory Verbal Learning Test from the NIH Toolbox Cognitive Battery. Scoring is automatically calculated by the NIH Toolbox App and is age normed, with higher scores indicating stronger performance on the task. | Assessed at baseline and after the 3 month intervention |
| Objective cognitive functioning: Visual memory | Participants will complete a visual memory task in which they see a series of pictures in a specified order. Immediately after, they are tasked with placing the pictures in the correct order. This is the Picture Sequence Memory Test from the NIH Toolbox Cognitive Battery. Scoring is automatically calculated by the NIH Toolbox App and is age normed, with higher scores indicating stronger performance on the task. | Assessed at baseline and after the 3 month intervention |
| Protocol Adherence | To assess protocol adherence, we will calculate number of days the Garmin is worn (all participants), the number of weeks participants met their physical activity goal (all participants), and the number of coaching sessions attended (participants in the tech enhanced group only). Higher numbers for each indicate greater levels of adherence to the protocol. | Assessed after the 3 month intervention is complete |
| Treatment Acceptance | To assess overall acceptability of the intervention, participants will complete a treatment acceptance survey specifically adapted for this study. This survey will include satisfaction and acceptability ratings, as well as open-ended questions to obtain participant feedback. Total scores are not calculated. This data will be used to improve the intervention for future studies. | Assessed after the 3 month intervention is complete |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D000085263 | Self-Testing |
| D012648 | Self Care |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |