BridgeMD
New treatment option for Chronic Pain
Official title A Mobile Intervention to Reduce Pain and Improve Health-III
ClinicalTrials.gov ID: NCT06623669
What this study is testing
- What it's testing
- The experience of chronic pain powerfully and negatively affects quality of life and functional independence in aging. Unfortunately, while as many as three in four older adults experience chronic pain, few have access to effective non-pharmacological pain management strategies.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- Aged 65+ years
- Body mass index of 30-45 kg/m2 or \>45 kg/m2 with physician's approval
- No loss or gain of more than 5% body mass in previous 6 months
- Presence of knee or hip osteoarthritis as ascertained via the Roux questionnaire
- Independently living
You likely can't join if
- Reside in skilled nursing facility, rehab or assisted living environment
- History of pharmacologic treatment for a psychiatric disorder other than depression/anxiety within past year
- Current untreated and/or unstable clinical depression or anxiety (Patient Health Questionnaire (PHQ-9) \>15)
- Hospitalization for psychiatric event within past year prior to screening
- History of mild cognitive impairment or dementia
- Cognitive impairment (\<32) on Modified Telephone Interview for Cognitive Status survey (TICS-M)
See the full eligibility criteria
- Aged 65+ years
- Body mass index of 30-45 kg/m2 or \>45 kg/m2 with physician's approval
- No loss or gain of more than 5% body mass in previous 6 months
- Presence of knee or hip osteoarthritis as ascertained via the Roux questionnaire
- Independently living
- Low active (i.e., not participating in regular resistance training and/or \>20 mins/day of aerobic exercise on more than 2 days/week in past 3 months as ascertained via a modified CHAMPS questionnaire)
- Have no contraindication for safe and optimal participation in exercise based on EASY screening (pertaining to chest pain and discomfort during physical activity, dizziness or light headedness, or frequent falls and use...
- Not currently using a weight loss medication (medications for diabetes management are permitted if weight stable)
- Approved for participation by medical director
- Willing to provide informed consent and agree to all study procedures and assessments.
- Reside in skilled nursing facility, rehab or assisted living environment
- History of pharmacologic treatment for a psychiatric disorder other than depression/anxiety within past year
- Current untreated and/or unstable clinical depression or anxiety (Patient Health Questionnaire (PHQ-9) \>15)
- Hospitalization for psychiatric event within past year prior to screening
- History of mild cognitive impairment or dementia
- Cognitive impairment (\<32) on Modified Telephone Interview for Cognitive Status survey (TICS-M)
- Hearing or visual impairment that would preclude use of the videoconferencing software
- Severe arthritis or other musculoskeletal disorder that is a contraindication for safe walking
- Presently undergoing treatment for orthopedic fracture
- Currently using a weight loss medication (medications for diabetes management are permitted if weight stable)
- Contraindication based on EASY screening (pertaining to chest pain and discomfort during physical activity, dizziness or light headedness, or frequent falls and use of assistive devices) without physician approval
- Joint replacement or other orthopedic surgery in past 6 months
- Joint replacement or other orthopedic surgery planned in next 18 months
- Have a diagnosis of uncontrolled hypertension; current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease other than asthma or COPD, any disease...
- Current participation in other research study with a prospective intervention
- Unable/unwilling to commit to study protocol, including random assignment and use of technology tools
- Unable/unwilling to attend three virtual testing appointments
The study team makes the final eligibility decision.
Where it's taking place
- Winston-Salem, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Winston-Salem, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.