MOTIVATE: Moving to Improve Outcomes for Older Adults

Back Pain Lower Back Chronic Clinical Trial

Official title:

MOTIVATE: Moving to Improve Chronic Back Pain and Depression in Older Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03914469
• Other study ID #: STU 2018-0084
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: June 30, 2025

Study information

• Verified date: October 2023
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: June 30, 2025
• Est. primary completion date: November 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Back Pain Lower Back Chronic

Intervention

Behavioral:
• Behavioral Intervention Group
The active intervention will include eight tele-delivered health coach sessions, three tele-based outcome assessments, and up to two semi-structured interviews at 6 months 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).

Locations

Country	Name	City	State
United States	Parkland Health & Hospital System	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rates	Of patients pre-screened, the total number enrolled into the study	Through study completion, up to 6 months
Primary	Rate of intervention completion	Of patients randomized into the intervention arm, the total number retained for follow-up	Through study completion, up to 6 months
Secondary	Pain scale	Pain intensity on 0-10 scale where higher values are worse pain	Through study completion, up to 6 months
Secondary	Roland Morris Disability Questionnaire (RMDQ)	Disability related to back pain. Scale ranges from 0-24 with larger numbers indicating worse disability related to chronic back pain.	Through study completion, up to 6 months
Secondary	Depression	Depression: Patient Health Questionnaire (PHQ-9) scored between 0-27 with higher numbers indicated worse depression.	Through study completion, up to 6 months
Secondary	Step counts	Physical activity: step counts measured using Omron pedometer. Participants will wear the pedometer clipped to their right lateral waistband for 24 hours per day for 7 consecutive days (except during shower or water activities) to obtain 5 complete days of physical activity data	Through 8 intervention sessions, up to 24 weeks