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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG035025 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Dartmouth College | OTHER |
| Johns Hopkins University | OTHER |
| University of Pennsylvania | OTHER |
| National Institute on Aging (NIA) |
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The goal of this study is to determine whether increasing participation in cognitive, physical, and/or social activities prevents cognitive decline in older African Americans (AAs) with Mild Cognitive Impairment (MCI). Patients with MCI are at increased risk for Alzheimer's Disease (AD); we propose that increasing participation in activities will prevent cognitive decline and may delay the onset of Alzheimer's Disease (AD). We will test this hypothesis by conducting a clinical trial in which older AAs with MCI (aged 65 years and older) will be randomized to Behavior Activation (BA) (a behavioral intervention that increases participation in daily activities) or Supportive Therapy (ST) (a person-centered psychotherapy that involves active listening and offering support focusing on participants' problems and concerns). We hypothesize that BA-treated subjects will have fewer declines in cognitive and functional abilities, fewer depressive and neuropsychiatric symptoms, and better quality of life than ST-treated subjects at 24 months.
The goal of this study is to determine whether increasing participation in activities prevents cognitive decline in older African Americans with Mild Cognitive Impairment (MCI). We will attempt to increase activities with Behavioral Activation (BA). BA is a manual-based, behavioral treatment to increase activities as a way to improve function and mood. As patients do more (through activation) and perceive the benefit (i.e., feel better), their activity levels increase. BA promotes activities that reflect an individual's preferences and goals by structuring, scheduling, and reinforcing daily activities. This increases participation in activities with strong personal value, such as social engagement or normative role function, which in turn enhances mood and motivation to remain active.
The control treatment is Supportive Therapy, which is a non-directive, supportive therapy that is based on empathy, reflection, and support.
This study is specifically targeting older African Americans (AAs). Most clinical trials for MCI have tested pharmacologic treatments and have enrolled mostly Whites; their results may not apply to AAs whose life experiences and medical and genetic characteristics may exert unique effects. Those with MCI are a high-risk population for whom interventions to prevent cognitive decline are particularly important. Because AAs comprise one of the largest minority groups in the U.S., suffer disparities in health outcomes, and are unlikely to seek pharmacologic treatments or participate in clinical drug trials, there is an urgent need to enroll older AAs in non-pharmacologic intervention studies of cognition.
We will recruit 200 AA subjects aged 65 and older who have amnestic Mild Cognitive Impairment (MCI) - Multiple Domain subtype of MCI (aMCI-MD). One of the inclusion criteria is for participants to have a Knowledgeable Informant (KI) who is willing to participate in the study (with the subject's permission as documented in the informed consent form). A KI is defined as a family member or friend who is identified by the subject as someone who has regular and frequent contact with the subject (at least twice per week) in-person or by phone. The KI will be asked to provide information regarding the subject's functioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavior Activation | Experimental | BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment. |
|
| Supportive Therapy (ST) | Placebo Comparator | ST is a person-centered treatment in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation (BA) | Behavioral | BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Decline of 6 Points on the Hopkins Verbal Learning Test-Revised (HVLT-R) | A decline of 6 points from baseline to 24 months on the Hopkins Verbal Learning Test-Revised (HVLT-R). Possible scores range from 0 to 12, with higher scores indicating better memory. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in University of California Performance-based Skills Assessment (UPSA) Score Per Year | The University of California Performance-based Skills Assessment (UPSA) was used as an objective test of accuracy with writing checks, making change, using a telephone, and scheduling a physician appointment (higher scores indicate better function). Possible scores range from 0 to 100. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robin J Casten, PhD | Thomas Jefferson University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31087388 | Derived | Rovner BW, Casten RJ, Leiby B. Memory improvement in African Americans with amnestic mild cognitive impairment. Int J Geriatr Psychiatry. 2019 Oct;34(10):1447-1454. doi: 10.1002/gps.5141. Epub 2019 Jun 18. | |
| 30208380 | Derived | Rovner BW, Casten RJ, Hegel MT, Leiby B. Preventing Cognitive Decline in Black Individuals With Mild Cognitive Impairment: A Randomized Clinical Trial. JAMA Neurol. 2018 Dec 1;75(12):1487-1493. doi: 10.1001/jamaneurol.2018.2513. |
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Prior to randomization, participants were administered neuropsychological tests to determine whether they met criteria for MCI. Participants with normal cognition and those with suspected dementia were excluded.
Enrollment from June 21, 2011 to October 3, 2014; follow-up ended December 13, 2016. Potential participants were recruited when they sought memory screening at senior centers, senior housing sites, churches, and primary care clinics in Philadelphia, PA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavior Activation | BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment. Behavioral Activation (BA): BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment. |
| FG001 | Supportive Therapy (ST) | ST is a person-centered treatment in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions. Supportive Therapy (ST): ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavior Activation | BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment. Behavioral Activation (BA): BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Decline of 6 Points on the Hopkins Verbal Learning Test-Revised (HVLT-R) | A decline of 6 points from baseline to 24 months on the Hopkins Verbal Learning Test-Revised (HVLT-R). Possible scores range from 0 to 12, with higher scores indicating better memory. | The primary analysis was performed on the modified intent to treat population including all available data from all participants with at least one follow-up visit. | Posted | Count of Participants | Participants | 24 months |
|
2 years
We reported hospitalizations
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavior Activation | BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment. Behavioral Activation (BA): BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Infections and infestations | Systematic Assessment | Death from septic shock |
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The racial characteristics of the sample and motivation to enroll a clinical trial, limit generalizability. Also, nonrandom attrition (higher in males) may have skewed results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robin Casten | Thomas Jefferson University | 215-503-1250 | robin.casten@jefferson.edu |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| NIH |
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| Supportive Therapy (ST) | Behavioral | ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions. |
|
| 27000348 | Derived | Rovner BW, Casten RJ. Preserving Cognition in Older African Americans with Mild Cognitive Impairment. J Am Geriatr Soc. 2016 Mar;64(3):659-61. doi: 10.1111/jgs.14012. No abstract available. |
| 25811797 | Derived | Rovner BW, Casten RJ, Leiby BE. Determinants of Activity Levels in African Americans With Mild Cognitive Impairment. Alzheimer Dis Assoc Disord. 2016 Jan-Mar;30(1):41-6. doi: 10.1097/WAD.0000000000000096. |
| 22406101 | Derived | Rovner BW, Casten RJ, Hegel MT, Leiby BE. Preventing cognitive decline in older African Americans with mild cognitive impairment: design and methods of a randomized clinical trial. Contemp Clin Trials. 2012 Jul;33(4):712-20. doi: 10.1016/j.cct.2012.02.016. Epub 2012 Mar 2. |
| BG001 | Supportive Therapy (ST) | ST is a person-centered treatment in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions. Supportive Therapy (ST): ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Supportive Therapy (ST) | ST is a person-centered treatment in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions. Supportive Therapy (ST): ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions. |
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|
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| Secondary | Change in University of California Performance-based Skills Assessment (UPSA) Score Per Year | The University of California Performance-based Skills Assessment (UPSA) was used as an objective test of accuracy with writing checks, making change, using a telephone, and scheduling a physician appointment (higher scores indicate better function). Possible scores range from 0 to 100. | The analysis was performed on the modified intent to treat population including all available data from all participants with at least one follow-up visit. | Posted | Mean | 95% Confidence Interval | units per year | 24 months |
|
|
|
|
| 5 |
| 111 |
| 40 |
| 111 |
| 0 |
| 111 |
| EG001 | Supportive Therapy (ST) | ST is a person-centered treatment in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions. Supportive Therapy (ST): ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions. | 4 | 110 | 35 | 110 | 0 | 110 |
| Death NOS | Investigations | Systematic Assessment | Death NOS |
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| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Fractured disk |
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| Broken shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Chrohn's Disease | Gastrointestinal disorders | Systematic Assessment |
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| Hernia repair | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Valve replacement | Cardiac disorders | Systematic Assessment |
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| Pacemaker implanted | Cardiac disorders | Systematic Assessment |
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| Seziure | Nervous system disorders | Systematic Assessment |
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| UTI | Infections and infestations | Systematic Assessment |
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| Asthma Attack | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Heart attack | Cardiac disorders | Systematic Assessment |
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| Stroke | Vascular disorders | Systematic Assessment |
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| bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dehydration | Renal and urinary disorders | Systematic Assessment |
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| bypass surgery | Cardiac disorders | Systematic Assessment |
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| hypoglycemia | Endocrine disorders | Systematic Assessment |
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| COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Chest pain | Cardiac disorders | Systematic Assessment |
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| Edema | Cardiac disorders | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| GI bleed | Gastrointestinal disorders | Systematic Assessment |
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| Acid reflux | Gastrointestinal disorders | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Blood clot | Blood and lymphatic system disorders | Systematic Assessment |
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| CHF | Cardiac disorders | Systematic Assessment |
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| GI symptoms | Gastrointestinal disorders | Systematic Assessment |
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| pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| aneurysm | Vascular disorders | Systematic Assessment |
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| Knee replacement | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| internal bleeding | Eye disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| infection | Infections and infestations | Systematic Assessment |
|
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