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| ID | Type | Description | Link |
|---|---|---|---|
| 75206 | Other Grant/Funding Number | Robert Wood Johnson Harold Amos Medical Faculty Program | |
| P30AG021334 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Robert Wood Johnson Foundation | OTHER |
| National Institute on Aging (NIA) | NIH |
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African American women who are 50 years of age and older with depressive symptoms, pain and difficulty with mobility will participate in the DAPPER intervention study that includes 8 nurse visits in participants' homes to help participants with participants' pain and mood.
The proposed intervention is called Depression and Pain Perseverance through Empowered Recovery (DAPPER). The investigators are adapting the Get Busy Get Better intervention by adding components (e.g. nurse visits and person directed goals) from the CAPABLE study for this intervention. The investigator will further develop the intervention through this two-phase pilot test. The aims of this pilot project are to 1) test the Depression and Pain Perseverance through Empowered Recovery (DAPPER) program for feasibility and acceptability. Specifically, the investigators will test the effect size of DAPPER on pain and depressive symptoms from baseline to 12 weeks (compare intervention to wait list control group) and then at 24 weeks to compare the intervention group to wait list control group once again. 2) estimate preliminary effect sizes for DAPPER in reduction pain and depressive symptoms, 3) measure effect sizes and feasibility of measuring cytokines and heart rate variability (HRV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | The intervention group will receive the intervention for 12 weeks. The wait list control group will have outcomes measured but will not receive the intervention at this time. |
|
| Wait List Control Arm | Active Comparator | Once the intervention group has completed the intervention the wait list control group will complete the intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAPPER | Behavioral | The DAPPER program is person directed and will consist of 8 nurse visits during which the nurse assesses each participant for pain, depression and frailty and then implements a manualized individually tailored intervention. Participants will be randomized into either the intervention or the wait list control group. Once the intervention group has completed the intervention group's visits, the wait list control group will begin the waitlist control group's visits. All participants will all be offered the same information and format of nurse visits. The nurses will systematically tailor the content of the visits to the participants' risk profile and goals based on protocols. All participants will be assessed at the start of the study, at 12 weeks and 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity as Assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) | The PROMIS Intensity is used to measure pain intensity on a scale of 0-10. Higher scores indicate more pain intensity. | Baseline and 12 weeks |
| Depressive Symptoms as Assessed by the Patient Health Questionnaire 9 (PHQ-9) | The Patient Health Questionnaire 9 (PHQ-9) includes 9 questions related to the Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnostic criteria for major depression. The PHQ-9 scores range from 0-27. Higher scores indicate more depressive symptoms. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin (IL)-6 in Saliva (pg/ml) | An decrease in IL 6 indicates a decrease in this inflammatory marker. | Baseline and 12 weeks |
| Interleukin (IL)-8 in Saliva (pg/ml) | A decrease indicates a decrease IL8 , which is an inflammatory marker. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Function as Assessed by the Katz Activities of Daily Living (ADL) | The Katz Activities of daily living (ADL) is used measure physical function through ability to perform activities of daily living. Score ranges are from 0-6 with 6 indicating full function and a score of 2 or less indicating severe functional impairment. | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janiece L Taylor, PhD | Johns Hopkins School of Nursing | Principal Investigator |
| Catherine Clair, MHS | Johns Hopkins University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins School of Nursing | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37478967 | Background | Taylor JL, Clair CA, Lee JW, Atkins S, Riser TJ, Szanton SL, McCoy MC, Thorpe RJ Jr, Wang C, Gitlin LN. A protocol for a wait list control trial of an intervention to improve pain and depressive symptoms among middle-aged and older African American women. Contemp Clin Trials. 2023 Sep;132:107299. doi: 10.1016/j.cct.2023.107299. Epub 2023 Jul 20. | |
| 38094930 | Result | Taylor JL, Clair CA, Gitlin LN, Atkins S, Bandeen-Roche K, Abshire Saylor M, Hladek MD, Riser TJ, Thorpe RJ Jr, Szanton SL. Acceptability and Feasibility of a Pain and Depressive Symptoms Management Intervention in Middle-Aged and Older African American Women. Innov Aging. 2023 Sep 8;7(10):igad096. doi: 10.1093/geroni/igad096. eCollection 2023. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| 37478967 | Study Protocol | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm | The intervention group will receive the intervention for 12 weeks. The wait list control group will have outcomes measured but will not receive the intervention at this time. DAPPER: The DAPPER program is person directed and will consist of 8 nurse visits during which the nurse assesses each participant for pain, depression and frailty and then implements a manualized individually tailored intervention. Participants will be randomized into either the intervention or the wait list control group. Once the intervention group has completed the intervention group's visits, the wait list control group will begin the waitlist control group's visits. All participants will all be offered the same information and format of nurse visits. The nurses will systematically tailor the content of the visits to the participants' risk profile and goals based on protocols. All participants will be assessed at the start of the study, at 12 weeks and 24 weeks. |
| FG001 | Wait List Control Arm | Once the intervention group has completed the intervention the wait list control group will complete the intervention. DAPPER: The DAPPER program is person directed and will consist of 8 nurse visits during which the nurse assesses each participant for pain, depression and frailty and then implements a manualized individually tailored intervention. Participants will be randomized into either the intervention or the wait list control group. Once the intervention group has completed the intervention group's visits, the wait list control group will begin the waitlist control group's visits. All participants will all be offered the same information and format of nurse visits. The nurses will systematically tailor the content of the visits to the participants' risk profile and goals based on protocols. All participants will be assessed at the start of the study, at 12 weeks and 24 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm | The intervention group will receive the intervention for 12 weeks. The wait list control group will have outcomes measured but will not receive the intervention at this time. DAPPER: The DAPPER program is person directed and will consist of 8 nurse visits during which the nurse assesses each participant for pain, depression and frailty and then implements a manualized individually tailored intervention. Participants will be randomized into either the intervention or the wait list control group. Once the intervention group has completed the intervention group's visits, the wait list control group will begin the waitlist control group's visits. All participants will all be offered the same information and format of nurse visits. The nurses will systematically tailor the content of the visits to the participants' risk profile and goals based on protocols. All participants will be assessed at the start of the study, at 12 weeks and 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Pain Intensity as Assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) | The PROMIS Intensity is used to measure pain intensity on a scale of 0-10. Higher scores indicate more pain intensity. | A total of 23 participants completed the intervention. Participants who completed this measure at baseline (pre intervention) and post intervention (12 + weeks), (13 participants in the intervention group and 10 in the control group). | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
Up to 45 months
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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 | Intervention Arm | The intervention group will receive the intervention for 12 weeks. The wait list control group will have outcomes measured but will not receive the intervention at this time. DAPPER: The DAPPER program is person directed and will consist of 8 nurse visits during which the nurse assesses each participant for pain, depression and frailty and then implements a manualized individually tailored intervention. Participants will be randomized into either the intervention or the wait list control group. Once the intervention group has completed the intervention group's visits, the wait list control group will begin the waitlist control group's visits. All participants will all be offered the same information and format of nurse visits. The nurses will systematically tailor the content of the visits to the participants' risk profile and goals based on protocols. All participants will be assessed at the start of the study, at 12 weeks and 24 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janiece Taylor | Johns Hopkins School of Nursing | 443-287-4503 | jwalke90@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 17, 2024 | Apr 8, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 5, 2024 | Apr 8, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D003863 | Depression |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
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The investigator will conduct subsequent single blind wait list control design to test the preliminary effects of DAPPER and the feasibility of older African American women integrating strategies to address pain, depression, and frailty that are tailored to the individual into the individual's daily routines.
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The statistician will be responsible for randomization and the investigator and study team will not have knowledge if participants are assigned to intervention group or wait list control group.
|
| Pre intervention , Post intervention 12 weeks for Intervention arm |
| Interleukin (IL)-1 Beta in Saliva (pg/ml) | A change in IL-1beta indicates a change in this cytokine or protein. | Baseline and Post intervention 12 weeks for intervention arm. Baseline for wait list control. |
| Tumor Necrosis Factor (TNF)-Alpha in Saliva (pg/ml) | Tumor necrosis factor (TNF)-alpha in saliva (pg/ml). TNF-alpha is a cytokine that signals inflammation in the body. Higher levels indicate there may be more inflammation. | Baseline and post intervention (12 weeks ) for intervention arm. Baseline only (wait list control arm) |
| Physical Function as Assessed by the Lawton's Instrumental Activities of Daily Living (IADL) |
Lawton's Instrumental Activities of Daily Living (IADL) measures instrumental activities of daily living as a measure of physical function. The scores range from 0-8 with higher scores indicating better physical function. |
| Baseline |
| Frailty as Assessed by the Frail Scale | The Frail Scale is used to measure frailty. The scores range from 0-17 with higher scores indicating more frailty. | Baseline |
| Change in Depressive Symptoms as Assessed by the PROMIS 57 | The Patient Reported Outcomes Measurement System (PROMIS)57 the Patient Reported Outcomes Measurement Information System (PROMIS) 57, which is includes an 8-item instrument that can be used to measure self-reported negative mood, view of self, and somatic symptoms. The score range for PROMIS 57 is 8-40. Higher scores indicate more depressive symptoms. | Nurse Visit 1 and Nurse Visit 8 |
| Stress as Assessed by the Perceived Stress Scale (Intervention Group) | The Perceived Stress Scale assesses a person's perceived stress levels. The scores can range from 0 to 40 with higher scores indicating higher perceived stress. | Pre intervention, Post intervention 12 weeks |
| Comorbid Conditions as Assessed by the Charlson Comorbidity Index | The Charlson Comorbidity Index consists of 17 categories of chronic conditions and two subcategories for diabetes and liver disease. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. Up to 12 comorbidities with various weightings can result in a maximum score of 24. Score range 0-24. | Baseline |
| Change in Social Engagement as Assessed by the Social Network Scale | The Lubben Social Network Scale -6 is used to measure social engagement including family and friends. The scores range from 0 to 60 with higher scores indicating more social engagement. | Baseline, 12 weeks and 24 weeks |
| Change in Self Efficacy as Assessed by the Coping and Self-Efficacy Scale | The Coping and Self-Efficacy Scale is a 26 item scale used to measure coping and self efficacy. The scores on this instrument range from 0-260 with higher scores indicating more self efficacy. | Baseline and 12 weeks |
| Change in Frailty as Assessed by the Frailty Phenotype Measure | The Frailty Phenotype measure is used to determine if a person is robust (score of 0), pre-frail (score of 1 or 2), or frail (score of 3-5). total score range of 0-5. | Baseline and 12 weeks |
| 38094930 | Outcomes Manuscript | View IPD |
| BG001 | Wait List Control Arm | Once the intervention group has completed the intervention the wait list control group will complete the intervention. DAPPER: The DAPPER program is person directed and will consist of 8 nurse visits during which the nurse assesses each participant for pain, depression and frailty and then implements a manualized individually tailored intervention. Participants will be randomized into either the intervention or the wait list control group. Once the intervention group has completed the intervention group's visits, the wait list control group will begin the waitlist control group's visits. All participants will all be offered the same information and format of nurse visits. The nurses will systematically tailor the content of the visits to the participants' risk profile and goals based on protocols. All participants will be assessed at the start of the study, at 12 weeks and 24 weeks. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Wait List Control Arm | Once the intervention group has completed the intervention the wait list control group will complete the intervention. DAPPER: The DAPPER program is person directed and will consist of 8 nurse visits during which the nurse assesses each participant for pain, depression and frailty and then implements a manualized individually tailored intervention. Participants will be randomized into either the intervention or the wait list control group. Once the intervention group has completed the intervention group's visits, the wait list control group will begin the waitlist control group's visits. All participants will all be offered the same information and format of nurse visits. The nurses will systematically tailor the content of the visits to the participants' risk profile and goals based on protocols. All participants will be assessed at the start of the study, at 12 weeks and 24 weeks. |
|
|
| Primary | Depressive Symptoms as Assessed by the Patient Health Questionnaire 9 (PHQ-9) | The Patient Health Questionnaire 9 (PHQ-9) includes 9 questions related to the Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnostic criteria for major depression. The PHQ-9 scores range from 0-27. Higher scores indicate more depressive symptoms. | A total of 23 participants completed the intervention. Participants who completed this measure at baseline (pre intervention) and post intervention (12 + weeks), (13 participants in the intervention group and 10 in the control group). | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | Interleukin (IL)-6 in Saliva (pg/ml) | An decrease in IL 6 indicates a decrease in this inflammatory marker. | Due to the COVID 19 pandemic, not all saliva samples were collected and not all samples had sufficient saliva. | Posted | Mean | Standard Deviation | picograms/millilitre | Baseline and 12 weeks |
|
|
|
| Secondary | Interleukin (IL)-8 in Saliva (pg/ml) | A decrease indicates a decrease IL8 , which is an inflammatory marker. | Due to the COVID 19 pandemic, not all saliva samples were collected and not all samples had sufficient saliva. | Posted | Mean | Standard Deviation | picograms/millilitre | Pre intervention , Post intervention 12 weeks for Intervention arm |
|
|
|
| Secondary | Interleukin (IL)-1 Beta in Saliva (pg/ml) | A change in IL-1beta indicates a change in this cytokine or protein. | Due to the COVID 19 pandemic, not all saliva samples were collected and not all samples had sufficient saliva. | Posted | Mean | Standard Deviation | picograms/millilitre | Baseline and Post intervention 12 weeks for intervention arm. Baseline for wait list control. |
|
|
|
| Secondary | Tumor Necrosis Factor (TNF)-Alpha in Saliva (pg/ml) | Tumor necrosis factor (TNF)-alpha in saliva (pg/ml). TNF-alpha is a cytokine that signals inflammation in the body. Higher levels indicate there may be more inflammation. | Due to the COVID 19 pandemic not all saliva samples were collected and there was insufficient amount of saliva for some of the samples. | Posted | Mean | Standard Deviation | pg/ml | Baseline and post intervention (12 weeks ) for intervention arm. Baseline only (wait list control arm) |
|
|
|
| Other Pre-specified | Physical Function as Assessed by the Katz Activities of Daily Living (ADL) | The Katz Activities of daily living (ADL) is used measure physical function through ability to perform activities of daily living. Score ranges are from 0-6 with 6 indicating full function and a score of 2 or less indicating severe functional impairment. | This was part of the inclusion criteria. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Other Pre-specified | Physical Function as Assessed by the Lawton's Instrumental Activities of Daily Living (IADL) | Lawton's Instrumental Activities of Daily Living (IADL) measures instrumental activities of daily living as a measure of physical function. The scores range from 0-8 with higher scores indicating better physical function. | This was measured as part of screening criteria to participate in the intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Other Pre-specified | Frailty as Assessed by the Frail Scale | The Frail Scale is used to measure frailty. The scores range from 0-17 with higher scores indicating more frailty. | We used this outcome as inclusion criteria versus a measured outcome pre and post intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Other Pre-specified | Change in Depressive Symptoms as Assessed by the PROMIS 57 | The Patient Reported Outcomes Measurement System (PROMIS)57 the Patient Reported Outcomes Measurement Information System (PROMIS) 57, which is includes an 8-item instrument that can be used to measure self-reported negative mood, view of self, and somatic symptoms. The score range for PROMIS 57 is 8-40. Higher scores indicate more depressive symptoms. | Data not collected. Investigators used the PhQ9 as the measure of depression for this study as opposed to PROMIS 57. | Posted | Nurse Visit 1 and Nurse Visit 8 |
|
|
| Other Pre-specified | Stress as Assessed by the Perceived Stress Scale (Intervention Group) | The Perceived Stress Scale assesses a person's perceived stress levels. The scores can range from 0 to 40 with higher scores indicating higher perceived stress. | Participants with data collected in the intervention group only | Posted | Mean | Standard Deviation | score on a scale | Pre intervention, Post intervention 12 weeks |
|
|
|
| Other Pre-specified | Comorbid Conditions as Assessed by the Charlson Comorbidity Index | The Charlson Comorbidity Index consists of 17 categories of chronic conditions and two subcategories for diabetes and liver disease. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. Up to 12 comorbidities with various weightings can result in a maximum score of 24. Score range 0-24. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Other Pre-specified | Change in Social Engagement as Assessed by the Social Network Scale | The Lubben Social Network Scale -6 is used to measure social engagement including family and friends. The scores range from 0 to 60 with higher scores indicating more social engagement. | This data has not been analyzed and was a potential outcome that we proposed in our protocol. | Posted | Baseline, 12 weeks and 24 weeks |
|
|
| Other Pre-specified | Change in Self Efficacy as Assessed by the Coping and Self-Efficacy Scale | The Coping and Self-Efficacy Scale is a 26 item scale used to measure coping and self efficacy. The scores on this instrument range from 0-260 with higher scores indicating more self efficacy. | Participants with data collected in the intervention group only | Posted | Baseline and 12 weeks |
|
|
| Other Pre-specified | Change in Frailty as Assessed by the Frailty Phenotype Measure | The Frailty Phenotype measure is used to determine if a person is robust (score of 0), pre-frail (score of 1 or 2), or frail (score of 3-5). total score range of 0-5. | Participants with data collected | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Wait List Control Arm | Once the intervention group has completed the intervention the wait list control group will complete the intervention. DAPPER: The DAPPER program is person directed and will consist of 8 nurse visits during which the nurse assesses each participant for pain, depression and frailty and then implements a manualized individually tailored intervention. Participants will be randomized into either the intervention or the wait list control group. Once the intervention group has completed the intervention group's visits, the wait list control group will begin the waitlist control group's visits. All participants will all be offered the same information and format of nurse visits. The nurses will systematically tailor the content of the visits to the participants' risk profile and goals based on protocols. All participants will be assessed at the start of the study, at 12 weeks and 24 weeks. | 0 | 17 | 0 | 17 | 0 | 17 |
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| D001519 | Behavior |
| D010335 | Pathologic Processes |