Clinical trial NCT06623669: A Mobile Intervention to Reduce Pain and Improve Health-III
Official title: A Mobile Intervention to Reduce Pain and Improve Health-III
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Chronic Pain
Osteoarthritis
Obesity and Overweight
Inactivity
Keywords: Digital health
Randomized Trial
Physical Activity
Weight Loss
Aging
Lead sponsor: Wake Forest University
Sponsor class: OTHER
Collaborators: name: Wake Forest University Health Sciences
name: Duke University
name: National Institute on Aging (NIA)
First posted: 2024-10-02
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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. Participating in regular physical activity, avoiding sustained sitting, and maintaining a healthy weight are important and interrelated lifestyle inputs to chronic pain, and socially rich behavioral interventions informed by contemporary theories of behavior change appear important for engaging in activity and healthy eating in the long term. Our group has demonstrated in a series of Stage I trials that a group-mediated behavioral intervention combining dietary behavior change and a physical activity program focused on moving often throughout the day contributes to meaningful weight loss, and lasting weight maintenance, with pilot data suggesting this may contribute to improved pain, physical function, and health-related quality of life among older adults with chronic pain. As these were NIH Stage I trials, there are several important gaps to be addressed in the present trial: (1) both studies of chronic pain recruited small samples and were 12 weeks in duration, limiting our ability to establish efficacy and the durability of changes to activity, HRQOL, and pain outcomes; (2) participants included anyone with chronic pain, regardless of pain type, a likely contributor to heterogeneous pain intensity and interference findings; and (3) the investigators have yet to examine behavioral maintenance.

The overarching goal of the proposed Stage II "mobile intervention to reduce pain and improve health-III (MORPH-III)" is to establish the efficacy of the intervention for enhancing physical activity via steps (primary), and for reducing pain interference and body weight while enhancing physical function (secondary) among older adults with chronic knee or hip osteoarthritic (OA) pain. The investigators will recruit 200 older adults with knee or hip osteoarthritic pain to engage in a 6-month remotely delivered intervention comprising weekly group or individual intervention meetings plus brief individual goal-setting coaching calls. This will be followed by a 12-month no-contact maintenance period, where participants will attempt to sustain behavioral goals on their own.

The Specific Aims are:

Specific Aim 1: To examine the impact of MORPH on ActivPAL-assessed daily steps relative to an enhanced usual care control. Hypotheses: MORPH will significantly increase steps relative to control at month 6.

Specific Aim 2: To examine the impact of MORPH on pain interference, change in body weight, and physical function relative to the enhanced usual care control. Hypotheses: MORPH will result in significant reductions in pain interference and body weight and improvement in physical function relative to control at month 6.

Exploratory Aims: Aim 1: To investigate the impact of the MORPH intervention on steps, weight change, pain interference, and physical function at month 18. Aim 2: If the MORPH intervention results in reduced pain interference at 6 and/or 18 months, the investigators will examine the extent to which 6-month change in steps, weight, pain self-efficacy, and catastrophizing mediate change in interference at 6 and/or 18 months.


Eligibility criteria: Inclusion Criteria:

* Aged 65+ years
* Body mass index of 30-45 kg/m2 or \>45 kg/m2 with physician 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 \&gt; 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
* 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) \&gt;15)
* Hospitalization for psychiatric event within past year prior to screening
* History of mild cognitive impairment or dementia
* Cognitive impairment (\&lt;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 \&gt;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

Primary outcomes:
measure: Daily steps
timeFrame: Baseline, after 6 months of intervention, after 18 months of intervention
Secondary outcomes:
measure: Pain Interference
timeFrame: Baseline, after 6 months of intervention, after 18 months of intervention
measure: Body weight
timeFrame: From the start of the intervention through month 18.
measure: 30-second chair stand
timeFrame: Baseline, after 6 months of intervention, after 18 months of intervention
measure: Gait speed
timeFrame: Baseline, after 6 months of intervention, after 18 months of intervention
Other outcomes:
measure: Physical activity behavior
timeFrame: Collected over one week at baseline, after 6 months of intervention, after 18 months of intervention
measure: Adverse Events
timeFrame: Baseline, after 6 months of intervention, after 18 months of intervention
measure: Participant Feedback
timeFrame: After 6 months of intervention
measure: Medication usage
timeFrame: Baseline, after 6 months of intervention, after 18 months of intervention
measure: Sleep behavior
timeFrame: Nightly over the 18-month intervention
measure: Pain intensity
timeFrame: Baseline, after 6 months of intervention, after 18 months of intervention
measure: Perceived physical function
timeFrame: Baseline, after 6 months of intervention, after 18 months of intervention.
measure: Pain Catastrophizing
timeFrame: Baseline, after 6 months of intervention, after 18 months of intervention
measure: Self-determinative needs
timeFrame: Baseline, after 6 months of intervention, after 18 months of intervention
measure: Affect
timeFrame: Baseline, after 6 months of intervention, after 18 months of intervention
measure: Stress
timeFrame: Baseline, after 6 months of intervention, after 18 months of intervention
measure: Exercise Self-Efficacy
timeFrame: Baseline, after 6 months of intervention, after 18 months of intervention
measure: Outcome Expectencies related to Eating Behavior
timeFrame: Baseline, after 6 months of intervention, after 18 months of intervention
measure: Outcome Expectencies related to Activity Behavior
timeFrame: Baseline, after 6 months of intervention, after 18 months of intervention
measure: Self-regulation
timeFrame: Baseline, after 6 months of intervention, after 18 months of intervention
measure: Barriers
timeFrame: Baseline, after 6 months of intervention, after 18 months of intervention
measure: Health-related quality of life
timeFrame: Baseline, after 6 months of intervention, after 18 months of intervention
measure: Perceived Sleep
timeFrame: Baseline, after 6 months of intervention, after 18 months of intervention
Locations:
Study officials:
affiliation: Wake Forest University
name: Jason Fanning, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Amber Brooks, MD
role: PRINCIPAL_INVESTIGATOR
References: