Recruiting

SPARK Intervention

Sponsor:

Johns Hopkins University

Code:

NCT07228520

Conditions

Pain

Depressive Symptoms

Aging

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

SPARK

Study Details

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.

Conditions

Pain

Depressive Symptoms

Aging

Study ID

NCT07228520

Start date

Jun 1, 2026

Status verified date

Jul, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Wait List Control Arm

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

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.

Primary outcome measure

  • Change in Pain Intensity as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Baseline, 12 weeks and 24 weeks ]
  • Change in Pain Interference as assessed by the PROMIS Pain Interference [ Time Frame: Baseline, 12 weeks and 24 weeks ]
  • Change in Depressive Symptoms as assessed by the Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: Baseline, 12 weeks and 24 weeks ]
  • Change in Depressive Symptoms as assessed by the PROMIS 57 [ Time Frame: Baseline, 12 weeks and 24 weeks ]

Central Contacts and Locations

Central contacts

Janiece Taylor, PhD

443-287-4503jwalke90@jhu.edu

Meagan Clemence, MS

mcleme26@jh.edu

Locations

Johns Hopkins School of Nursing

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Janiece Taylor, PhD

443-287-4503jwalke90@jhu.edu

Sarah Szanton, PhD

(410) 502-2605 ssszanto1@jhu.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Older Adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-07-22.