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Older adults who are 50 years of age and older with depressive symptoms, pain and difficulty with mobility will participate in the SPARK intervention study that includes 8 nurse visits in participants' homes to help participants with participants' pain and mood.
SPARK (Strength and Pain-Coping through Resilience and Knowledge) is a home-based, nurse-delivered behavioral intervention designed to reduce pain interference and depressive symptoms among community-dwelling older adults with mobility limitations. Chronic pain and depression occurs together later in life and can impair daily function, independence, and overall well-being. Pain interference, how pain affects daily life, is a critical and actionable outcome that is closely linked to depressive symptoms. SPARK integrates evidence-informed strategies delivered through the Neighborhood Nursing model and brings the necessary care directly to the homes of the participants. The intervention comprises eight weekly individualized 1:1 nurse home visits that integrate goal-directed care planning, education on pain and mood self-management, and coordination with Neighborhood Nursing and Community Health workers to address barriers and leverage local resources.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPARK 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. |
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| Wait List Control Arm | Active Comparator | Once the intervention group has completed the intervention the wait list control group will complete the intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPARK | Behavioral | The SPARK 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 |
|---|---|---|
| Change in 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, 12 weeks and 24 weeks |
| Change in Pain Interference as assessed by the PROMIS Pain Interference | The Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference is a six item scale used to measure how much pain interferes with activities. The scores can range from 6-30. Higher scores indicate more pain interference with activities. | Baseline, 12 weeks and 24 weeks |
| Change in 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, 12 weeks and 24 weeks |
| 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. | Baseline, 12 weeks and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 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, 12 weeks and 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janiece Taylor, PhD | Contact | 443-287-4503 | jwalke90@jhu.edu | |
| Catherine Clair, MHS | Contact | cclair1@jhu.edu |
| 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 | Recruiting | 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 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| 37478967 | Study Protocol | View IPD |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D003863 | Depression |
| 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.
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| Change in 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, 12 weeks and 24 weeks |
| 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. |
| 38094930 | Outcomes Manuscript | View IPD |
| D001519 | Behavior |