Skip to content

Strength and Pain-Coping Through Resilience and Knowledge

Strength and Pain-Coping Through Resilience and Knowledge

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07228520
Acronym
SPARK
Enrollment
100
Registered
2025-11-14
Start date
2026-02-02
Completion date
2028-11-30
Last updated
2025-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Depressive Symptoms, Aging

Keywords

Older Adults

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALSPARK

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.

Sponsors

Johns Hopkins University
Lead SponsorOTHER

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
ALL
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 * Live in the community * Live in Central Maryland * 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

MeasureTime frameDescription
Change in Pain Intensity as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)Baseline, 12 weeks and 24 weeksThe PROMIS Intensity is used to measure pain intensity on a scale of 0-10. Higher scores indicate more pain intensity.
Change in Pain Interference as assessed by the PROMIS Pain InterferenceBaseline, 12 weeks and 24 weeksThe 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.
Change in Depressive Symptoms as assessed by the Patient Health Questionnaire 9 (PHQ-9)Baseline, 12 weeks and 24 weeksThe 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.
Change in Depressive Symptoms as assessed by the PROMIS 57Baseline, 12 weeks and 24 weeksThe 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.

Secondary

MeasureTime frameDescription
Change in Physical Function as assessed by the Katz Activities of daily living (ADL)Baseline, 12 weeks and 24 weeksThe 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 Physical Function as assessed by the Lawton's Instrumental Activities of Daily Living (IADL)Baseline, 12 weeks and 24 weeksLawton'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.

Countries

United States

Contacts

Primary ContactJaniece Taylor, PhD
jwalke90@jhu.edu443-287-4503
Backup ContactCatherine Clair, MHS
cclair1@jhu.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026