MOTIVATE: Moving to Improve Outcomes for Older Adults

NCT03914469 | Terminated Results

• 1 other identifier: STU 2018-0084
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Back Pain Lower Back Chronic

Outcome Measures

Primary Outcomes (2)

• Recruitment Rates

  Of patients pre-screened, the total number enrolled into the study

  Through study completion, up to 6 months

• 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 Outcomes (4)

• Pain Scale

  at approximately 4 months

• Roland Morris Disability Questionnaire (RMDQ)

  at approximately 4 months

• Depression

  at approximately 4 months

• Step Counts

  at approximately 3 months

Study Arms (2)

Waitlist Control Group

NO INTERVENTION

The waitlist control group will continue with management of chronic back pain and depression per usual care. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant. Subjects randomized to the waitlist control group will be offered the same intervention once the active intervention group has completed the active sessions and assessments.

Behavioral Intervention Group

EXPERIMENTAL

For participants assigned to the intervention arm, trained health coaches will deliver the intervention via telephone. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant.

Behavioral: Behavioral Intervention Group

Interventions

Behavioral Intervention Group BEHAVIORAL

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).

Behavioral Intervention Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

Parkland Health & Hospital System

Dallas, Texas, 75235, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Limitations and Caveats

Due to poor recruitment and early termination of this study, the collected data for the limited enrolled participants were not considered valid for any useful assessment for outcomes#3-6. Hence, these outcomes were not analyzed.

Results Point of Contact

• Title: Dr. Makris
• Organization: UT Southwestern Medical Center

una.makris@utsouthwestern.edu

214 648 3133

Study Officials

• Una Makris, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research staff conducting outcomes assessments will be blinded to whether the subject is in active or waitlist group
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 16, 2019
• Study Start: August 1, 2019
• Primary Completion: November 7, 2022
• Study Completion: December 6, 2022
• Last Updated: March 14, 2025
• Results First Posted: August 12, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)