Cognitive Change, Health Behavior, Health Literacy
Conditions
Brief summary
The goal of this R21 study is to explore the feasibility and preliminary efficacy of individualized cognitive prescriptions (CogRxs) in improving engagement in healthy behaviors and other outcomes in middle-aged AAs and to gain feedback on future implementation of the program.
Detailed description
A pre-post experimental design will be used, in which 150 AA participants aged 50-65 will complete a baseline assessment of cognitive testing and data-driven assessment of deficiencies across five CogRx domains (physical activity, cognitive activity, diet, sleep, social activity). Participants will be randomized to either: psychoeducation + CogRx, psychoeducation only, or no contact control. The psychoeducation and CogRx groups will receive general psychoeducation on dementia prevalence, prognosis, and risk factors, while the CogRx group will also receive personalized information on their risk factor profile and develop a tailored 3-month intervention plan, which will consist of simple evidence-based strategies to implement at home. Motivational reminders as well as adherence and self-efficacy questions will be administered via text-messaging over the 3-months. Participants will return for 3-month and 6-month follow-ups. Specific Aim 1 (proximal outcomes) is to determine whether the CogRx condition is superior to psychoeducation alone in improving engagement in healthy lifestyle behaviors. Specific Aim 2 (distal outcomes) is to compare the three conditions on a brief battery of cognitive and psychological measures. The Exploratory Aim is to gather feedback for future implementation of this program, including cultural considerations, barriers and facilitators to engagement, and likelihood of continuing the program.
Interventions
BEHAVIORALCognitive Prescriptions
Personalized information on their risk factor profile across five CogRx domains (physical activity, cognitive activity, diet, sleep, social activity) and develop a tailored 3-month intervention plan, which will consist of simple evidence-based strategies to implement at home.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A pre-post experimental design will be used, in which 150 AA participants aged 50-65 will complete a baseline assessment of cognitive testing and data-driven assessment of deficiencies across five CogRx domains (physical activity, cognitive activity, diet, sleep, social activity). Participants will be randomized to either: psychoeducation + CogRx, psychoeducation only, or no-contact control.
Eligibility
Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusions: * Must be African American * Must be age 50 to 65 * Must have a working cell phone with unlimited texting * Must be ambulatory Exclusions: * No neurological (including dementia diagnosis) or severe psychiatric (e.g., schizophrenia or bipolar disorder) disorders * No insomnia * Telephone Interview for Cognitive Status (TICS) score ≤20
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leisure Activities Questionnaire Activities Sum | change from baseline to 3 months | The full measure is a 30-item survey asking about frequency of activities across 4 domains (cognitive, physical, social, and passive), in which higher scores reflect greater engagement in each type of activity (participants rate on Likert scale how often they perform each activity, 0=never/occasionally to 7=daily). The results below reflect a sum of cognitive, physical, and social activities (19 total activities). The total possible sum range is 0 to 133. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dementia Knowledge | change from baseline to 3 months | Scores on the Dementia Knowledge Assessment Scale (DKAS-27) which assesses knowledge about risk factors and prognosis of dementia. Scores include percentage correct for the 27 items, with scores ranging from 0-100%. There are 27 items and each item is scored as correct or incorrect. Therefore the scores include a percentage of total items correct, ranging from 0-100 with higher meaning better knowledge. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No-contact Control No-contact control, no contact for 3 months | 14 |
| Psychoeducation Control Receives general psychoeducation on dementia prevalence, prognosis, and risk factors. | 12 |
| Psychoeducation + CogRx Receives same general psychoeducation on dementia and will also receive personalized information on their risk factor profile and develop a tailored 3-month intervention plan, which will consist of simple evidence-based strategies to implement at home.
Cognitive Prescriptions: Personalized information on their risk factor profile across five CogRx domains (physical activity, cognitive activity, diet, sleep, social activity) and develop a tailored 3-month intervention plan, which will consist of simple evidence-based strategies to implement at home. | 13 |
| Total | 39 |
Baseline characteristics
| Characteristic | No-contact Control | Total | Psychoeducation + CogRx | Psychoeducation Control |
|---|---|---|---|---|
| Age, Continuous | 56.4 years STANDARD_DEVIATION 4.6 | 56.08 years STANDARD_DEVIATION 5.05 | 55.8 years STANDARD_DEVIATION 4.4 | 56.0 years STANDARD_DEVIATION 6.5 |
| Employment Status Not working (unemployed, retired, on disability) | 6 Participants | 12 Participants | 3 Participants | 3 Participants |
| Employment Status Working full or part time | 8 Participants | 27 Participants | 10 Participants | 9 Participants |
| Marital Status In relationship | 3 Participants | 15 Participants | 7 Participants | 5 Participants |
| Marital Status Single, Divorced, or Widowed | 11 Participants | 24 Participants | 6 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 39 Participants | 13 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 14 participants | 39 participants | 13 participants | 12 participants |
| Sex: Female, Male Female | 11 Participants | 32 Participants | 11 Participants | 10 Participants |
| Sex: Female, Male Male | 3 Participants | 7 Participants | 2 Participants | 2 Participants |
| TICS-telephone interview for cognitive status | 35.2 units on a scale STANDARD_DEVIATION 3.3 | 34.67 units on a scale STANDARD_DEVIATION 3.55 | 35.2 units on a scale STANDARD_DEVIATION 4 | 33.4 units on a scale STANDARD_DEVIATION 3.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 12 | 0 / 13 |
| other Total, other adverse events | 0 / 14 | 0 / 12 | 0 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 12 | 0 / 13 |
Outcome results
Primary
Leisure Activities Questionnaire Activities Sum
The full measure is a 30-item survey asking about frequency of activities across 4 domains (cognitive, physical, social, and passive), in which higher scores reflect greater engagement in each type of activity (participants rate on Likert scale how often they perform each activity, 0=never/occasionally to 7=daily). The results below reflect a sum of cognitive, physical, and social activities (19 total activities). The total possible sum range is 0 to 133.
Time frame: change from baseline to 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No-contact Control | Leisure Activities Questionnaire Activities Sum | 1.45 score on a scale |
| Psychoeducation Control | Leisure Activities Questionnaire Activities Sum | 4.45 score on a scale |
| Psychoeducation + CogRx | Leisure Activities Questionnaire Activities Sum | 11.25 score on a scale |
p-value: <0.05Mixed Models Analysis
Secondary
Dementia Knowledge
Scores on the Dementia Knowledge Assessment Scale (DKAS-27) which assesses knowledge about risk factors and prognosis of dementia. Scores include percentage correct for the 27 items, with scores ranging from 0-100%. There are 27 items and each item is scored as correct or incorrect. Therefore the scores include a percentage of total items correct, ranging from 0-100 with higher meaning better knowledge.
Time frame: change from baseline to 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No-contact Control | Dementia Knowledge | 10 score on a scale |
| Psychoeducation Control | Dementia Knowledge | 27 score on a scale |
| Psychoeducation + CogRx | Dementia Knowledge | 19 score on a scale |
p-value: <0.05Mixed Models Analysis