Strength and Pain-Coping Through Resilience and Knowledge

Not Applicable

Not yet recruiting

• Conditions: Pain; Depressive Symptoms; Aging

• Registration Number: NCT07228520
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-13
• Study First Submitted QC: 2025-11-13
• Last Update Submitted: 2025-11-13
• Study First Posted: 2025-11-14
• Last Update Posted: 2025-11-14
• Study Start: 2026-02-02
• Primary Completion: 2028-11-30
• Study Completion: 2028-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Pain Intensity as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)	Baseline, 12 weeks and 24 weeks	The 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 Interference	Baseline, 12 weeks and 24 weeks	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.
Change in Depressive Symptoms as assessed by the Patient Health Questionnaire 9 (PHQ-9)	Baseline, 12 weeks and 24 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.
Change in Depressive Symptoms as assessed by the PROMIS 57	Baseline, 12 weeks and 24 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Johns Hopkins School of Nursing; 🇺🇸 Baltimore, Maryland, United States