Aging, Depressive Symptoms, Frailty, Pain
Conditions
Keywords
African American, Women's Health
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALDAPPER
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.
Sponsors
Robert Wood Johnson Foundation
National Institute on Aging (NIA)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Self-report pain \>3 out of a 0 -10 scale that has lasted longer than 3 months and keeps subjects from doing at least one activity that subjects would like to do * Self-Identify as African American/Black female * Live in a community dwelling * Score a 5 or higher on the PHQ-9 (depression measure) at least two times during a two week period (screening call and then at first data collection visit) * Must be pre-frail (one or two criteria on frailty phenotype) or frail (three or more of the criteria on frailty phenotype) * One ADL or IADL limitation
Exclusion criteria
* Hospitalized \> 3 times in the last year * Participating in physical therapy * Have a terminal diagnosis (\<1 year expected survival) * \> moderate intellectual impairment (5-7 errors) based on the Short Portable Mental Status Questionnaire (SPMSQ) * Unable to speak or understand English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity as Assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) | Baseline and 12 weeks | The PROMIS Intensity is used to measure pain intensity on a scale of 0-10. Higher scores indicate more pain intensity. |
| Depressive Symptoms as Assessed by the Patient Health Questionnaire 9 (PHQ-9) | Baseline and 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin (IL)-6 in Saliva (pg/ml) | Baseline and 12 weeks | An decrease in IL 6 indicates a decrease in this inflammatory marker. |
| Interleukin (IL)-8 in Saliva (pg/ml) | Pre intervention , Post intervention 12 weeks for Intervention arm | A decrease indicates a decrease IL8 , which is an inflammatory marker. |
| Interleukin (IL)-1 Beta in Saliva (pg/ml) | Baseline and Post intervention 12 weeks for intervention arm. Baseline for wait list control. | A change in IL-1beta indicates a change in this cytokine or protein. |
| Tumor Necrosis Factor (TNF)-Alpha in Saliva (pg/ml) | Baseline and post intervention (12 weeks ) for intervention arm. Baseline only (wait list control arm) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Social Engagement as Assessed by the Social Network Scale | Baseline, 12 weeks and 24 weeks | 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. |
| Physical Function as Assessed by the Katz Activities of Daily Living (ADL) | Baseline | 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. |
| Change in Frailty as Assessed by the Frailty Phenotype Measure | Baseline and 12 weeks | 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. |
| Change in Self Efficacy as Assessed by the Coping and Self-Efficacy Scale | Baseline and 12 weeks | 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. |
| Physical Function as Assessed by the Lawton's Instrumental Activities of Daily Living (IADL) | Baseline | 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. |
| Frailty as Assessed by the Frail Scale | Baseline | The Frail Scale is used to measure frailty. The scores range from 0-17 with higher scores indicating more frailty. |
| Change in Depressive Symptoms as Assessed by the PROMIS 57 | Nurse Visit 1 and Nurse Visit 8 | 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. |
| Stress as Assessed by the Perceived Stress Scale (Intervention Group) | Pre intervention, Post intervention 12 weeks | 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. |
| Comorbid Conditions as Assessed by the Charlson Comorbidity Index | Baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| 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. | 17 |
| Total | 34 |
Baseline characteristics
| Characteristic | Intervention Arm | Total | Wait List Control Arm |
|---|---|---|---|
| Age, Continuous | 64.9 Years STANDARD_DEVIATION 11 | 64.8 Years STANDARD_DEVIATION 10.5 | 64.6 Years STANDARD_DEVIATION 10.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 34 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 17 Participants | 34 Participants | 17 Participants |
| Sex: Female, Male Female | 17 Participants | 34 Participants | 17 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
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.
Time frame: Baseline and 12 weeks
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Depressive Symptoms as Assessed by the Patient Health Questionnaire 9 (PHQ-9) | Baseline | 12.25 score on a scale | Standard Deviation 3.13 |
| Intervention Arm | Depressive Symptoms as Assessed by the Patient Health Questionnaire 9 (PHQ-9) | 12 weeks | 8.36 score on a scale | Standard Deviation 4.43 |
| Wait List Control Arm | Depressive Symptoms as Assessed by the Patient Health Questionnaire 9 (PHQ-9) | Baseline | 11.53 score on a scale | Standard Deviation 4.78 |
| Wait List Control Arm | Depressive Symptoms as Assessed by the Patient Health Questionnaire 9 (PHQ-9) | 12 weeks | 11.43 score on a scale | Standard Deviation 4.67 |
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.
Time frame: Baseline and 12 weeks
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Pain Intensity as Assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) | Baseline | 6.75 score on a scale | Standard Deviation 2.18 |
| Intervention Arm | Pain Intensity as Assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) | 12 weeks | 6.64 score on a scale | Standard Deviation 1.8 |
| Wait List Control Arm | Pain Intensity as Assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) | Baseline | 7.29 score on a scale | Standard Deviation 1.57 |
| Wait List Control Arm | Pain Intensity as Assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) | 12 weeks | 7.00 score on a scale | Standard Deviation 1.35 |
Secondary
Interleukin (IL)-1 Beta in Saliva (pg/ml)
A change in IL-1beta indicates a change in this cytokine or protein.
Time frame: Baseline and Post intervention 12 weeks for intervention arm. Baseline for wait list control.
Population: Due to the COVID 19 pandemic, not all saliva samples were collected and not all samples had sufficient saliva.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Interleukin (IL)-1 Beta in Saliva (pg/ml) | Pre intervention | 154.7 picograms/millilitre | Standard Deviation 90.37 |
| Intervention Arm | Interleukin (IL)-1 Beta in Saliva (pg/ml) | Post intervention 12 weeks | 247.47 picograms/millilitre | Standard Deviation 379.06 |
| Wait List Control Arm | Interleukin (IL)-1 Beta in Saliva (pg/ml) | Pre intervention | 564.35 picograms/millilitre | Standard Deviation 571.66 |
| Wait List Control Arm | Interleukin (IL)-1 Beta in Saliva (pg/ml) | Post intervention 12 weeks | 347.73 picograms/millilitre | Standard Deviation 357.62 |
Secondary
Interleukin (IL)-6 in Saliva (pg/ml)
An decrease in IL 6 indicates a decrease in this inflammatory marker.
Time frame: Baseline and 12 weeks
Population: Due to the COVID 19 pandemic, not all saliva samples were collected and not all samples had sufficient saliva.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Interleukin (IL)-6 in Saliva (pg/ml) | Baseline | 7.97 picograms/millilitre | Standard Deviation 6.22 |
| Intervention Arm | Interleukin (IL)-6 in Saliva (pg/ml) | 12 weeks | 5.12 picograms/millilitre | Standard Deviation 5.31 |
| Wait List Control Arm | Interleukin (IL)-6 in Saliva (pg/ml) | Baseline | 8.19 picograms/millilitre | Standard Deviation 3.66 |
| Wait List Control Arm | Interleukin (IL)-6 in Saliva (pg/ml) | 12 weeks | 7.54 picograms/millilitre | Standard Deviation 3.88 |
Secondary
Interleukin (IL)-8 in Saliva (pg/ml)
A decrease indicates a decrease IL8 , which is an inflammatory marker.
Time frame: Pre intervention , Post intervention 12 weeks for Intervention arm
Population: Due to the COVID 19 pandemic, not all saliva samples were collected and not all samples had sufficient saliva.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Interleukin (IL)-8 in Saliva (pg/ml) | Pre intervention | 1780.22 picograms/millilitre | Standard Deviation 1629.85 |
| Intervention Arm | Interleukin (IL)-8 in Saliva (pg/ml) | Post intervention 12 weeks | 1305.79 picograms/millilitre | Standard Deviation 1618.97 |
| Wait List Control Arm | Interleukin (IL)-8 in Saliva (pg/ml) | Pre intervention | 2847.77 picograms/millilitre | Standard Deviation 1583.21 |
| Wait List Control Arm | Interleukin (IL)-8 in Saliva (pg/ml) | Post intervention 12 weeks | 1805.99 picograms/millilitre | Standard Deviation 1613.66 |
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.
Time frame: Baseline and post intervention (12 weeks ) for intervention arm. Baseline only (wait list control arm)
Population: Due to the COVID 19 pandemic not all saliva samples were collected and there was insufficient amount of saliva for some of the samples.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Tumor Necrosis Factor (TNF)-Alpha in Saliva (pg/ml) | Pre intervention | 5.09 pg/ml | Standard Deviation 7.57 |
| Intervention Arm | Tumor Necrosis Factor (TNF)-Alpha in Saliva (pg/ml) | Post intervention 12 weeks | 3.56 pg/ml | Standard Deviation 3.84 |
| Wait List Control Arm | Tumor Necrosis Factor (TNF)-Alpha in Saliva (pg/ml) | Pre intervention | 7.66 pg/ml | Standard Deviation 4.32 |
| Wait List Control Arm | Tumor Necrosis Factor (TNF)-Alpha in Saliva (pg/ml) | Post intervention 12 weeks | 4.68 pg/ml | Standard Deviation 2.94 |
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.
Time frame: Nurse Visit 1 and Nurse Visit 8
Population: Data not collected. Investigators used the PhQ9 as the measure of depression for this study as opposed to PROMIS 57.
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.
Time frame: Baseline and 12 weeks
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Change in Frailty as Assessed by the Frailty Phenotype Measure | 3.15 score on a scale | Standard Deviation 0.55 |
| Wait List Control Arm | Change in Frailty as Assessed by the Frailty Phenotype Measure | 3.29 score on a scale | Standard Deviation 0.49 |
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.
Time frame: Baseline and 12 weeks
Population: Participants with data collected in the intervention group only
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.
Time frame: Baseline, 12 weeks and 24 weeks
Population: This data has not been analyzed and was a potential outcome that we proposed in our protocol.
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Comorbid Conditions as Assessed by the Charlson Comorbidity Index | 3.8 score on a scale | Standard Deviation 1.9 |
| Wait List Control Arm | Comorbid Conditions as Assessed by the Charlson Comorbidity Index | 3.9 score on a scale | Standard Deviation 2 |
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.
Time frame: Baseline
Population: We used this outcome as inclusion criteria versus a measured outcome pre and post intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Frailty as Assessed by the Frail Scale | 2.9 score on a scale | Standard Deviation 0.7 |
| Wait List Control Arm | Frailty as Assessed by the Frail Scale | 2.8 score on a scale | Standard Deviation 0.6 |
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.
Time frame: Baseline
Population: This was part of the inclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Physical Function as Assessed by the Katz Activities of Daily Living (ADL) | 2.7 score on a scale | Standard Deviation 1.8 |
| Wait List Control Arm | Physical Function as Assessed by the Katz Activities of Daily Living (ADL) | 2.6 score on a scale | Standard Deviation 1.7 |
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.
Time frame: Baseline
Population: This was measured as part of screening criteria to participate in the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Physical Function as Assessed by the Lawton's Instrumental Activities of Daily Living (IADL) | 3.2 score on a scale | Standard Deviation 1.8 |
| Wait List Control Arm | Physical Function as Assessed by the Lawton's Instrumental Activities of Daily Living (IADL) | 3.1 score on a scale | Standard Deviation 1.7 |
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.
Time frame: Pre intervention, Post intervention 12 weeks
Population: Participants with data collected in the intervention group only
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Stress as Assessed by the Perceived Stress Scale (Intervention Group) | Pre intervention | 25 score on a scale | Standard Deviation 8 |
| Intervention Arm | Stress as Assessed by the Perceived Stress Scale (Intervention Group) | Post intervention 12 weeks | 22.2 score on a scale | Standard Deviation 9.2 |