The PROACTIVE Study for Black Elders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-92
SponsorUniversity of Florida
About this trial
Chronic musculoskeletal pain (CMP), while a leading cause of physical disablement, is a neglected national health disparity issue in Black communities. The purpose of this study is to test a novel culturally congruent pain self-management intervention. A total of 120 persons aged 50-92, self-identifying as Black or African American having CMP will be invited to participate in this study. The primary outcome measured throughout this 3-year study is movement-evoked pain (MEP).
Eligibility criteria
Qualifiers
Self-identify as being part of the Black American diaspora (Black/African American, Afro-Caribbean)
Age 50-92 years
Self-report chronic musculoskeletal pain (CMP) as defined as persistent or recurrent pain lasting 6 months or longer that arises as part of a disease or injurious process directly affecting bone(s), joint(s), muscle(s), or related soft tissue(s)
Self-report a chronic musculoskeletal condition (e.g., osteoarthritis, chronic low back pain) in at least one lower extremity joint (hip, knee, low back, or ankle pain)
Disqualifiers
Unwilling to be randomized to either study arm
Self-reported diagnosis of sickle cell disease or related thalassemias
History of major neurological event (e.g., stroke) or current neurological disease (e.g., Parkinson's disease, multiple sclerosis, epilepsy)
Major cardiovascular problem in the past 6 months that would cause shortness of breath and/or chest pain (e.g. myocardial infarction, coronary artery bypass graft, or valve replacement, pulmonary embolism or deep venous thrombosis) or uncontrolled Hypertension (Systolic Blood Pressure (SBP) > 170 mmHg, Diastolic Blood Pressure (DBP) > 90 mmHg) OR Hypotension (SBP <90 mmHg, DBP <60 mmHg)
Trial design
Treatments tested in this trial
- PROACTIVE Intervention
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Florida
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator
Source ClinicalTrials.gov