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NCT Number: NCT07228520

Strength and Pain-Coping Through Resilience and Knowledge

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.

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Key information

Conditions

Pain Aging Behavior Behavioral Symptoms Depression Depressive Symptoms Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

Location status: Recruiting

Location contact

Janiece Taylor, PhD

CONTACT

[email protected]

443-287-4503

Sarah Szanton, PhD

CONTACT

[email protected]

(410) 502-2605 s

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Pain Intensity as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)

    Time frame: 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.

  2. Change in Pain Interference as assessed by the PROMIS Pain Interference

    Time frame: 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.

  3. Change in Depressive Symptoms as assessed by the Patient Health Questionnaire 9 (PHQ-9)

    Time frame: 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.

  4. Change in Depressive Symptoms as assessed by the PROMIS 57

    Time frame: 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 outcomes

  1. Change in Physical Function as assessed by the Katz Activities of daily living (ADL)

    Time frame: 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.

  2. Change in Physical Function as assessed by the Lawton's Instrumental Activities of Daily Living (IADL)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Janiece Taylor, PhD

CONTACT

[email protected]

443-287-4503

Meagan Clemence, MS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Acronym: SPARK

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 14, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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