Clinical trial NCT03914469: MOTIVATE: Moving to Improve Outcomes for Older Adults
Official title: MOTIVATE: Moving to Improve Chronic Back Pain and Depression in Older Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Back Pain Lower Back Chronic
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigators will assess the feasibility of a tele-delivered behavioral change intervention among older adults (aged 50 and older) with cLBP and depression. Fifty participants will be randomly assigned to one of two groups, behavioral intervention arm (n=25) versus the waitlist control arm (n=25).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overarching goal of this study is to evaluate a tele-based behavioral change intervention for older adults (aged 50 years and older) with chronic low back pain (cLBP) and comorbid depression, and to ultimately assess its effect on cLBP-related disability and depressive symptoms.

Investigators will conduct a pilot randomized control trial to assess feasibility for older adults with chronic low back pain and depression to receive a behavioral change tele-based intervention delivered by a health coach trained in motivational interviewing. All participants, regardless of intervention arm assigned, will undergo outcomes assessments (baseline, mid-point, final assessments) conducted by a blinded research assistant.

Detailed description: Investigators will assess the feasibility of a tele-delivered behavioral change intervention among older adults (aged 50 and older) with chronic low back pain and depression. Fifty participants will be randomly assigned to one of two groups, behavioral intervention arm (n=25) versus the waitlist control arm (n=25). The active intervention will include eight tele-delivered health coach sessions, three tele-based outcome assessments, and up to two semi-structured interviews within 6 months of completion, post-intervention. Each tele-based outcome assessment is roughly 45-60 minutes and will be conducted by a member of the research team. Each intervention session will be delivered by a trained health coach over a period of 10-20 weeks (up to 5 months total, accounting for additional time between sessions if needed).

The first session will introduce the participant to the health coach and the program, establish rapport, and measure baseline physical activity. The following six sessions address behavioral determinants, followed by a final session designed to be a booster session to the overall program.

An Omron pedometer will be provided to each participant for the assessment of physical activity. The Omron pedometer will be set up by a member of the research team (e.g., stride length, setting date/time) and will be mailed to the participant's home address between sessions one and two. Each participant will receive a courtesy phone call when the pedometer is mailed and will be asked to call the research coordinator when it arrives. The research team will provide technical assistance and instructions to the participant regarding use. The pedometer is intended to be worn on the waist band, daily, with the exception of times when the participant may shower or bathe. The research team will verbally instruct the participant on how to press the mode and memory buttons in order to provide weekly step counts for tracking physical activity. The participants will be prompted by the health coach or research staff to report step counts during subsequent weekly tele-based coaching sessions.

Since the investigators are interested in better understanding feasibility of the intervention as compared to the waitlist control, and how behaviors are sustained over time, the study involves follow-up to 6 months. Investigators will use these follow-up data to better understand differential attrition as well as preliminary formative implementation evaluation. Using purposive sampling, investigators will conduct \~ 10 in-depth semi-structured interviews. Each interview will occur \~six months post-intervention and will include key stakeholders from the following groups: study participants from each arm of the pilot study, the health coach, primary care and mental health providers.

The research staff will select participants identified as higher risk for drop-out, less engaged, or were particularly successful at achieving behavioral change. The purpose of the final interviews is to learn about the barriers and facilitators to successful intervention delivery and participant retention from the perspectives of the enrolled patients, health coach, and providers. Interview topics will borrow from components of the well-established framework, Promoting Action on Research Implementation in Health Services (PARiHS). Semi-structured interview strategy is informed by two Promoting Action on Research Implementation in Health Services (PARiHS) dimensions: context-how the microsystem (UTSW) impacts behavioral change uptake, for example, potential facilitators to intervention implementation; facilitation-identifying specific ways to augment the likelihood of implementation.

Eligibility criteria: Inclusion Criteria:

* Aged 50 and older
* English- speaking
* Working telephone
* Capable of participating in home-based activity
* Chronic low back pain with intensity of 4 or higher on 10 point scale
* Self-reported low back pain (+/-radiation) in the past 3 months that interferes with daily activities on most days
* Depression, PHQ-9\>10 stable (per chart review, no psychotic or suicidal ideation; confirmed over telephone)

Exclusion Criteria:

* Aged 49 or less
* No telephone
* Not English speaking
* Unwilling to be randomized to either study arm
* Self-reported, uncorrected hearing or visual disturbance precluding ability to participate in telephone sessions or read pedometer screen
* Cognitive impairment, assessed by Memory Impairment Screen
* Lumbar surgery within the last year
* Self-reported dependence on wheelchair, bed-bound, or severe balance impairment (unable to participate in physical activity intervention)
* Illness requiring hospitalization within the last 3 months (e.g., fall, gout attacks, stroke, heart attack, heart failure, or surgery for blocked arteries)
* Suicidal ideation or prior psychotic episodes requiring hospitalization within the last year

Primary outcomes:
measure: Recruitment Rates
timeFrame: Through study completion, up to 6 months
measure: Rate of Intervention Completion
timeFrame: Through study completion, up to 6 months
Secondary outcomes:
measure: Pain Scale
timeFrame: at approximately 4 months
measure: Roland Morris Disability Questionnaire (RMDQ)
timeFrame: at approximately 4 months
measure: Depression
timeFrame: at approximately 4 months
measure: Step Counts
timeFrame: at approximately 3 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Health & Hospital System
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Una Makris, MD
role: PRINCIPAL_INVESTIGATOR
References: