Strength and Pain-Coping Through Resilience and Knowledge
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
SPARK
BehavioralThe 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: SPARK Intervention ArmExperimental treatment 1 intervention
Group B: Wait List Control ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Pain Intensity as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)
The PROMIS Intensity is used to measure pain intensity on a scale of 0-10. Higher scores indicate more pain intensity.
Time frame
Baseline, 12 weeks and 24 weeks2
Change in Pain Interference as assessed by the PROMIS Pain Interference
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.
Time frame
Baseline, 12 weeks and 24 weeks3
Change in Depressive Symptoms as assessed by the Patient Health Questionnaire 9 (PHQ-9)
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.
Time frame
Baseline, 12 weeks and 24 weeks4
Change in Depressive Symptoms as assessed by the PROMIS 57
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.
Time frame
Baseline, 12 weeks and 24 weeksSecondary outcomes
1
Change in Physical Function as assessed by the Katz Activities of daily living (ADL)
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.
Time frame
Baseline, 12 weeks and 24 weeks2
Change in Physical Function as assessed by the Lawton's Instrumental Activities of Daily Living (IADL)
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.
Time frame
Baseline, 12 weeks and 24 weeksSponsors and contacts
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Source ClinicalTrials.gov