Trial Outcomes & Findings for Depression and Pain Perseverance Through Empowered Recovery Intervention (NCT NCT04091347)
NCT ID: NCT04091347
Last Updated: 2025-11-19
Results Overview
The PROMIS Intensity is used to measure pain intensity on a scale of 0-10. Higher scores indicate more pain intensity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2025-11-19
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Depression and Pain Perseverance Through Empowered Recovery Intervention
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=17 Participants
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.
|
Wait List Control Arm
n=17 Participants
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.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.9 Years
STANDARD_DEVIATION 11
|
64.6 Years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
64.8 Years
STANDARD_DEVIATION 10.5 • n=8 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
|
17 Participants
n=4 Participants
|
34 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
|
17 Participants
n=4 Participants
|
34 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
17 Participants
|
17 Participants
n=4 Participants
|
34 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: 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).
The PROMIS Intensity is used to measure pain intensity on a scale of 0-10. Higher scores indicate more pain intensity.
Outcome measures
| Measure |
Intervention Arm
n=13 Participants
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.
|
Wait List Control Arm
n=10 Participants
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.
|
|---|---|---|
|
Pain Intensity as Assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)
Baseline
|
6.75 score on a scale
Standard Deviation 2.18
|
7.29 score on a scale
Standard Deviation 1.57
|
|
Pain Intensity as Assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)
12 weeks
|
6.64 score on a scale
Standard Deviation 1.80
|
7.00 score on a scale
Standard Deviation 1.35
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Intervention Arm
n=13 Participants
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.
|
Wait List Control Arm
n=10 Participants
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.
|
|---|---|---|
|
Depressive Symptoms as Assessed by the Patient Health Questionnaire 9 (PHQ-9)
Baseline
|
12.25 score on a scale
Standard Deviation 3.13
|
11.53 score on a scale
Standard Deviation 4.78
|
|
Depressive Symptoms as Assessed by the Patient Health Questionnaire 9 (PHQ-9)
12 weeks
|
8.36 score on a scale
Standard Deviation 4.43
|
11.43 score on a scale
Standard Deviation 4.67
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Due to the COVID 19 pandemic, not all saliva samples were collected and not all samples had sufficient saliva.
An decrease in IL 6 indicates a decrease in this inflammatory marker.
Outcome measures
| Measure |
Intervention Arm
n=10 Participants
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.
|
Wait List Control Arm
n=4 Participants
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.
|
|---|---|---|
|
Interleukin (IL)-6 in Saliva (pg/ml)
Baseline
|
7.97 picograms/millilitre
Standard Deviation 6.22
|
8.19 picograms/millilitre
Standard Deviation 3.66
|
|
Interleukin (IL)-6 in Saliva (pg/ml)
12 weeks
|
5.12 picograms/millilitre
Standard Deviation 5.31
|
7.54 picograms/millilitre
Standard Deviation 3.88
|
SECONDARY outcome
Timeframe: Pre intervention , Post intervention 12 weeks for Intervention armPopulation: Due to the COVID 19 pandemic, not all saliva samples were collected and not all samples had sufficient saliva.
A decrease indicates a decrease IL8 , which is an inflammatory marker.
Outcome measures
| Measure |
Intervention Arm
n=10 Participants
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.
|
Wait List Control Arm
n=4 Participants
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.
|
|---|---|---|
|
Interleukin (IL)-8 in Saliva (pg/ml)
Post intervention 12 weeks
|
1305.79 picograms/millilitre
Standard Deviation 1618.97
|
1805.99 picograms/millilitre
Standard Deviation 1613.66
|
|
Interleukin (IL)-8 in Saliva (pg/ml)
Pre intervention
|
1780.22 picograms/millilitre
Standard Deviation 1629.85
|
2847.77 picograms/millilitre
Standard Deviation 1583.21
|
SECONDARY outcome
Timeframe: 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.
A change in IL-1beta indicates a change in this cytokine or protein.
Outcome measures
| Measure |
Intervention Arm
n=10 Participants
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.
|
Wait List Control Arm
n=4 Participants
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.
|
|---|---|---|
|
Interleukin (IL)-1 Beta in Saliva (pg/ml)
Pre intervention
|
154.7 picograms/millilitre
Standard Deviation 90.37
|
564.35 picograms/millilitre
Standard Deviation 571.66
|
|
Interleukin (IL)-1 Beta in Saliva (pg/ml)
Post intervention 12 weeks
|
247.47 picograms/millilitre
Standard Deviation 379.06
|
347.73 picograms/millilitre
Standard Deviation 357.62
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intervention Arm
n=10 Participants
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.
|
Wait List Control Arm
n=4 Participants
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.
|
|---|---|---|
|
Tumor Necrosis Factor (TNF)-Alpha in Saliva (pg/ml)
Pre intervention
|
5.09 pg/ml
Standard Deviation 7.57
|
7.66 pg/ml
Standard Deviation 4.32
|
|
Tumor Necrosis Factor (TNF)-Alpha in Saliva (pg/ml)
Post intervention 12 weeks
|
3.56 pg/ml
Standard Deviation 3.84
|
4.68 pg/ml
Standard Deviation 2.94
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: This was part of the inclusion criteria.
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.
Outcome measures
| Measure |
Intervention Arm
n=17 Participants
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.
|
Wait List Control Arm
n=17 Participants
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.
|
|---|---|---|
|
Physical Function as Assessed by the Katz Activities of Daily Living (ADL)
|
2.7 score on a scale
Standard Deviation 1.8
|
2.6 score on a scale
Standard Deviation 1.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: This was measured as part of screening criteria to participate in the intervention.
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.
Outcome measures
| Measure |
Intervention Arm
n=17 Participants
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.
|
Wait List Control Arm
n=17 Participants
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.
|
|---|---|---|
|
Physical Function as Assessed by the Lawton's Instrumental Activities of Daily Living (IADL)
|
3.2 score on a scale
Standard Deviation 1.8
|
3.1 score on a scale
Standard Deviation 1.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: We used this outcome as inclusion criteria versus a measured outcome pre and post intervention.
The Frail Scale is used to measure frailty. The scores range from 0-17 with higher scores indicating more frailty.
Outcome measures
| Measure |
Intervention Arm
n=17 Participants
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.
|
Wait List Control Arm
n=17 Participants
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.
|
|---|---|---|
|
Frailty as Assessed by the Frail Scale
|
2.9 score on a scale
Standard Deviation 0.7
|
2.8 score on a scale
Standard Deviation 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Nurse Visit 1 and Nurse Visit 8Population: Data not collected. Investigators used the PhQ9 as the measure of depression for this study as opposed to 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre intervention, Post intervention 12 weeksPopulation: Participants with data collected in the intervention group only
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.
Outcome measures
| Measure |
Intervention Arm
n=10 Participants
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.
|
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.
|
|---|---|---|
|
Stress as Assessed by the Perceived Stress Scale (Intervention Group)
Pre intervention
|
25 score on a scale
Standard Deviation 8.0
|
—
|
|
Stress as Assessed by the Perceived Stress Scale (Intervention Group)
Post intervention 12 weeks
|
22.2 score on a scale
Standard Deviation 9.2
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineThe 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.
Outcome measures
| Measure |
Intervention Arm
n=17 Participants
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.
|
Wait List Control Arm
n=17 Participants
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.
|
|---|---|---|
|
Comorbid Conditions as Assessed by the Charlson Comorbidity Index
|
3.8 score on a scale
Standard Deviation 1.9
|
3.9 score on a scale
Standard Deviation 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 12 weeks and 24 weeksPopulation: This data has not been analyzed and was a potential outcome that we proposed in our protocol.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 weeksPopulation: Participants with data collected in the intervention group only
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 weeksPopulation: Participants with data collected
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.
Outcome measures
| Measure |
Intervention Arm
n=13 Participants
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.
|
Wait List Control Arm
n=13 Participants
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.
|
|---|---|---|
|
Change in Frailty as Assessed by the Frailty Phenotype Measure
|
3.15 score on a scale
Standard Deviation 0.55
|
3.29 score on a scale
Standard Deviation 0.49
|
Adverse Events
Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait List Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place