A Mobile Intervention to Reduce Pain and Improve Health-III

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorWake Forest University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • MORPH

    Behavioral

    A remote behavioral intervention combining coaching and digital health tools to improve diet and activity behaviors.

  • Measurement Only

    Behavioral

    This intervention entails receipt of a body weight scale and wearable activity monitor.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: MORPHExperimental treatment 1 intervention
Group B: Measurement OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Daily steps

Daily steps measured over one week via the ActivPAL accelerometer

Time frame
Baseline, after 6 months of intervention, after 18 months of intervention

Secondary outcomes

1

Pain Interference

Measured via questionnaire: the Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item pain interference scale, which produces a t-score such that the population mean is a 50 with a standard deviation of 10; higher scores indicate higher interference.

Time frame
Baseline, after 6 months of intervention, after 18 months of intervention
2

Body weight

Measured via the BodyTrace wireless body weight scale

Time frame
From the start of the intervention through month 18.
3

30-second chair stand

Measured via in-home chair stand task.

Time frame
Baseline, after 6 months of intervention, after 18 months of intervention
4

Gait speed

Measured via in-home test: 4-meter habitual gait speed

Time frame
Baseline, after 6 months of intervention, after 18 months of intervention

Other outcomes

1

Physical activity behavior

Directly measured using the ActivPAL 4 accelerometer

Time frame
Collected over one week at baseline, after 6 months of intervention, after 18 months of intervention
2

Adverse Events

Assessed via assessor query and spontaneous report

Time frame
Baseline, after 6 months of intervention, after 18 months of intervention
3

Participant Feedback

Assessed via semi-structured interview

Time frame
After 6 months of intervention
4

Medication usage

Assessed via assessor query

Time frame
Baseline, after 6 months of intervention, after 18 months of intervention

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University

Lead sponsor

Wake Forest University Health Sciences

Collaborator

Duke University

Collaborator

National Institute on Aging (NIA)

Collaborator