Strength and Pain-Coping Through Resilience and Knowledge

NCT ID: NCT07228520

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-02
• Study Completion Date: 2028-11-30

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.

Conditions

Pain; Depressive Symptoms; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SPARK 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.

Group Type: EXPERIMENTAL

SPARK

Intervention Type: 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.

Wait List Control Arm

Once the intervention group has completed the intervention the wait list control group will complete the intervention.

Group Type: ACTIVE_COMPARATOR

SPARK

Intervention Type: 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.

Interventions

SPARK

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janiece L Taylor, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Nursing

Catherine Clair, MHS

Role: STUDY_DIRECTOR

Johns Hopkins University

Locations

Johns Hopkins School of Nursing

Baltimore, Maryland, United States

Countries

United States

Central Contacts

Janiece Taylor, PhD

Role: CONTACT

jwalke90@jhu.edu

443-287-4503

Catherine Clair, MHS

Role: CONTACT

cclair1@jhu.edu

References

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.

Reference Type: BACKGROUND

PMID: 37478967 (View on PubMed)

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.

Reference Type: RESULT

PMID: 38094930 (View on PubMed)

Study Documents

Document Type: Study Protocol

View Document

Document Type: Outcomes Manuscript

View Document

Other Identifiers

IRB00529967

Identifier Type: -

Identifier Source: org_study_id