Timing of Catheter Removal for Post-Surgery Walking Recovery

(EDUCaRe Trial)

Overseen By Sharon Bradshaw Bradshaw

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Lower extremity amputation, Bladder/kidney dysfunction, Spinal cord injuries, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Motivational Interviewing Program for Fatigue Management in the clinical trial Timing of Catheter Removal for Post-Surgery Walking Recovery?

The Lupus Intervention Fatigue Trial (LIFT) suggests that motivational interviewing can help reduce fatigue and increase physical activity in people with lupus, which might also support recovery after surgery by encouraging more movement and better energy management. ^{1 2 3 4 5}

How does the Motivational Interviewing Program for Fatigue Management differ from other treatments for post-surgery walking recovery?

The Motivational Interviewing Program for Fatigue Management is unique because it focuses on using motivational interviewing techniques to encourage physical activity and improve dietary habits, which can help reduce fatigue. This approach is different from traditional treatments that may not address lifestyle changes or use motivational strategies to enhance recovery. ^{1 2 3 6 7}

What is the purpose of this trial?

The study aims to compare between early versus delayed urinary catheter removal the impact on time to ambulation (in minutes) after minimally invasive lumbar spine surgery

Research Team

Brandon Carlson, MD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

This trial is for adults aged 18 and older who are undergoing one- or two-level minimally invasive lumbar fusion procedures. It's not specified, but typically people with other health issues that could affect walking or catheter use might be excluded.

Inclusion Criteria

I had a minor surgery to fuse one or two bones in my lower back.

Exclusion Criteria

I have had major surgery.

I am unable to give consent for medical procedures.

I have existing issues with my bladder, kidneys, or urinary tract.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Surgery and Immediate Postoperative Care

Participants undergo minimally invasive lumbar spine surgery and immediate postoperative care, including early or delayed urinary catheter removal

1 day

In-hospital stay

Postoperative Monitoring

Participants are monitored for ambulation time, urinary tract infections, pain medication usage, and other postoperative outcomes

1 to 3 days

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after discharge, including urinary tract infection and catheter reinsertion

Up to 1 month

Treatment Details

Interventions

• Active comparator
• Experimental

Trial Overview The study compares the effects of removing a urinary catheter early versus later on how soon patients can walk after minimally invasive back surgery. Participants will be divided into two groups to test this.

Participant Groups

Group I: Early Urethral Catheter Removal Experimental Treatment 1 Intervention

Removal of the urethral catheter in the operating room at the conclusion of surgery

Group II: Delayed Urethral Catheter Removal Active Control 1 Intervention

Removal of the urethral catheter in next morning after surgery

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Findings from Research

The Lupus Intervention Fatigue Trial (LIFT) is a randomized controlled trial involving 236 participants aimed at reducing fatigue in individuals with systemic lupus erythematosus (SLE) through a six-month motivational interviewing program compared to an educational control.

The primary outcome of the study is the change in fatigue levels measured by the Fatigue Severity Score after six months, with additional assessments of physical activity and dietary adherence, which will help develop future strategies for managing fatigue in SLE patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing intervention for increasing physical activity and improving dietary behaviors: The Lupus Intervention Fatigue Trial protocol. Kinnett-Hopkins, D., Ehrlich-Jones, L., Chmiel, JS., et al.[2023]

In a study of 515 systemic lupus erythematosus (SLE) patients, factors such as Caucasian ethnicity, pain levels, abnormal illness-related behaviors, and feelings of helplessness were linked to increased fatigue, highlighting the importance of psychological and social factors in managing fatigue.

Interestingly, traditional SLE-specific measures like disease activity and damage did not correlate with fatigue levels, suggesting that interventions to reduce fatigue should focus on addressing pain and psychological well-being rather than just disease severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disease activity and damage are not associated with increased levels of fatigue in systemic lupus erythematosus patients from a multiethnic cohort: LXVII. Burgos, PI., Alarcón, GS., McGwin, G., et al.[2022]

Designing randomized controlled trials (RCTs) for systemic lupus erythematosus (SLE) is challenging due to the variability of disease symptoms and the inadequacy of existing disease activity indices, which were not specifically designed for RCT outcomes.

The medical outcomes survey short form-36 (SF-36) has been shown to better reflect the effects of SLE and correlate with disease activity, treatment intensity, and patient outcomes, suggesting it could be a valuable tool in assessing treatment efficacy in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trial design in systemic lupus erythematosus: lessons learned and future directions. Strand, V.[2017]

In a study of 81 patients with systemic lupus erythematosus (SLE), disease status was found to be a direct predictor of fatigue, indicating that managing the underlying disease may help reduce fatigue levels.

Helplessness and depression were identified as mediating factors between disease status and fatigue, but over time, disease status remained the sole predictor of fatigue, highlighting the importance of addressing the disease itself for effective fatigue management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disease status predicts fatigue in systemic lupus erythematosus. Tayer, WG., Nicassio, PM., Weisman, MH., et al.[2006]

In a study of 51 Swedish patients with systemic lupus erythematosus (SLE), seven different fatigue questionnaires were evaluated to determine the minimal clinically important difference (MCID) for measuring fatigue, with estimates ranging from 4.3 to 17.0 depending on the method used.

While all seven questionnaires were effective in detecting MCIDs for fatigue, the Numeric Rating Scale (NRS) was less favored by respondents and provided the least favorable estimates, suggesting it may not be the best tool for assessing fatigue in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of the minimal clinically important difference for seven measures of fatigue in Swedish patients with systemic lupus erythematosus. Pettersson, S., Lundberg, IE., Liang, MH., et al.[2022]

The study evaluated the measurement properties of three fatigue scales (FACIT-F, SF-36 Vitality, and LupusQoL Fatigue) using data from two phase 3 clinical trials involving systemic lupus erythematosus (SLE) patients, revealing that while FACIT-F had good reliability (0.93), the other scales showed significant limitations, particularly SF-36 Vitality with a low reliability of 0.53.

Pooled fatigue items from the scales improved psychometric properties and were more sensitive in detecting changes in fatigue over time, indicating a need for further research to enhance fatigue measurement tools for better application in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric Analysis from EMBODY1 and 2 Clinical Trials to Help Select Suitable Fatigue PRO Scales for Future Systemic Lupus Erythematosus Studies. Cleanthous, S., Bongardt, S., Marquis, P., et al.[2023]

In a study of 130 women with systemic lupus erythematosus (SLE), fatigue was found to be multidimensional, with general and physical fatigue being the most pronounced, influenced by factors like disease activity, damage, and depressed mood.

Depressed mood was identified as the strongest contributor to mental fatigue, while physical fatigue was linked to disease-related factors and lifestyle aspects, highlighting the need for tailored interventions to address both dimensions of fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dimensions of fatigue in systemic lupus erythematosus: relationship to disease status and behavioral and psychosocial factors. Da Costa, D., Dritsa, M., Bernatsky, S., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Motivational interviewing intervention for increasing physical activity and improving dietary behaviors: The Lupus Intervention Fatigue Trial protocol. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Disease activity and damage are not associated with increased levels of fatigue in systemic lupus erythematosus patients from a multiethnic cohort: LXVII. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Clinical trial design in systemic lupus erythematosus: lessons learned and future directions. [2017]

4. Canada pubmed.ncbi.nlm.nih.gov

Disease status predicts fatigue in systemic lupus erythematosus. [2006]

5. England pubmed.ncbi.nlm.nih.gov

Determination of the minimal clinically important difference for seven measures of fatigue in Swedish patients with systemic lupus erythematosus. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Psychometric Analysis from EMBODY1 and 2 Clinical Trials to Help Select Suitable Fatigue PRO Scales for Future Systemic Lupus Erythematosus Studies. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Dimensions of fatigue in systemic lupus erythematosus: relationship to disease status and behavioral and psychosocial factors. [2022]