A Mobile Intervention to Reduce Pain and Improve Health-III
Launched by WAKE FOREST UNIVERSITY · Sep 30, 2024
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
The clinical trial titled "Mobile Intervention to Reduce Pain and Improve Health-III" (MORPH-III) is studying how a specially designed program can help older adults with chronic knee or hip pain due to osteoarthritis. The goal is to see if this program can encourage more physical activity, reduce pain, and help participants maintain a healthy weight. The trial will involve 200 older adults, aged 65 and above, who have a body mass index (BMI) of 30 or higher and are not very active. To qualify, participants must live independently and have a confirmed diagnosis of knee or hip osteoarthritis.
During the 6-month program, participants will join weekly group or individual meetings and receive coaching calls to set personal goals. After this active phase, there will be an additional 12 months where participants will try to maintain their goals on their own. The trial will measure changes in daily steps, pain levels, body weight, and overall physical function. This is an exciting opportunity for older adults who are struggling with chronic pain to potentially improve their quality of life through guided support and lifestyle changes.
Gender
ALL
Eligibility criteria
- Inclusion 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
- • Not currently using a weight loss medication
- • Approved for participation by medical director
- • Willing to provide informed consent and agree to all study procedures and assessments.
- Exclusion Criteria:
- • 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
- • Contraindication based on EASY screening 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 requiring oxygen use, neurological or hematological disease; cancer requiring current treatment, except non-melanoma skin cancers; kidney failure requiring dialysis; have a Katz ADL disability; or engage in heavy alcohol use \>14 drinks/week.
- • 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
About Wake Forest University
Wake Forest University is a leading academic institution known for its commitment to innovative research and excellence in education. The university's clinical trial sponsor arm focuses on advancing medical knowledge and improving patient care through rigorous clinical investigations. With a multidisciplinary team of experienced researchers and healthcare professionals, Wake Forest University engages in a wide range of clinical studies that span various therapeutic areas. The institution emphasizes ethical practices, participant safety, and collaboration with industry and regulatory bodies to ensure the integrity and success of its clinical trials. Through its robust research infrastructure, Wake Forest University aims to translate scientific discoveries into effective clinical solutions, ultimately enhancing health outcomes for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Winston Salem, North Carolina, United States
Patients applied
Trial Officials
Jason Fanning, PhD
Principal Investigator
Wake Forest University
Amber Brooks, MD
Principal Investigator
Wake Forest University Health Sciences
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported