Personalized Coaching for Fatigue

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Not willing to wear Fitbit, others

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

Compensation: Varies

Number of Visits: 1

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Emergency Medicine (EM) requires 24/7 staff coverage resulting in healthcare workers' circadian rhythm disruptions that impair clinical and cognitive performance, physical recovery, and contribute to burnout. Multiple well-being surveys continue to highlight EM's challenges with sleep impairment due to the nature of the specialty. Despite evidence that lifestyle strategies effectively optimize performance and recovery, EM residents have variable lifestyle choices to prepare for overnight shifts. This prospective randomized controlled trial will examine whether a pre-shift personalized fatigue-mitigation lifestyle coaching (PFMLC) for EM residents on overnight shifts minimizes the effects of circadian rhythm disruptions on performance and recovery compared to those who receive one-time passive information on lifestyle practices. All participants will receive lifestyle strategy materials on fatigue mitigation to improve performance. Residents' self-reported and biometric data will inform PFMLC in the active arm. Performance and recovery from night shifts will be assessed by changes in sleep, heart rate variability, readiness/recovery, alertness, cognitive performance, and mental health using Fitbit and validated measures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on lifestyle coaching and does not mention medication changes.

What data supports the effectiveness of the treatment Personalized coaching for fatigue?

Research on occupational performance coaching for people with multiple sclerosis suggests that adding coaching sessions can support self-directed fatigue management, indicating potential benefits of personalized coaching for managing fatigue. ^{1 2 3 4 5}

Is personalized coaching for fatigue safe for humans?

Research on lifestyle coaching for fatigue, including in brain tumor patients and people with multiple sclerosis, suggests it is feasible and does not report any major safety concerns. This implies that personalized coaching is generally safe for humans. ^{1 5 6 7 8}

How is personalized coaching for fatigue different from other treatments?

Personalized coaching for fatigue is unique because it involves tailored guidance and support, often through digital platforms, to help individuals manage their fatigue based on their specific needs and experiences. This approach contrasts with standard treatments that may not be as individualized or interactive. ^{1 2 9 10 11}

Eligibility Criteria

This trial is for emergency medicine residents who have at least four consecutive overnight shifts. Participants must be open to receiving text messages, meeting with a lifestyle coach, using an app on their smartphone, wearing a Fitbit device during the study, and answering questionnaires.

Inclusion Criteria

I am an emergency medicine resident with at least 4 overnight shifts in a row.

Exclusion Criteria

I am not willing to meet with a lifestyle coach during the study.

I do not want to receive text messages during the study.

I am not willing to download an app on my smartphone.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline

Collection of baseline characteristics and confounding factors such as gender, habitual diet, sleep, and caffeine intake

1 week

Daily data collection

Intervention

Participants receive personalized fatigue-mitigation lifestyle coaching or passive information on lifestyle practices during night shifts

1 week

Daily data collection and coaching sessions

Follow-up

Participants are monitored for changes in performance and recovery metrics after night shifts

1 week

Daily data collection

Treatment Details

Interventions

• Personalized coaching

Trial Overview The trial tests if personalized fatigue-mitigation coaching before night shifts can help emergency medicine residents perform better and recover faster compared to just getting a nutrition handout. It measures sleep quality, heart rate variability, alertness, cognitive performance, and mental health.

Participant Groups

Group I: Intervention Experimental Treatment 2 Interventions

Coaching provided. Nutrition handout also provided

Group II: Control Active Control 1 Intervention

No coaching provided. Nutrional handout only

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Findings from Research

A study involving 50 cancer patients demonstrated that using a 7-day fatigue diary was highly feasible, with 94% of participants completing it, which helped them better understand and manage their fatigue.

After using the diary, patients reported feeling less helpless about their fatigue and were more proactive in discussing it with their healthcare providers, indicating that fatigue diaries can significantly enhance self-management and awareness of fatigue patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cancer patients' perspective on feasibility of using a fatigue diary and the benefits on self-management: results from a longitudinal study. Milzer, M., Steindorf, K., Reinke, P., et al.[2022]

A study involving 21 women with breast cancer showed that adherence to an Individualized Sleep Promotion Plan (ISPP) was high (77%-88%), which included strategies like sleep hygiene and relaxation therapy, leading to generally positive sleep outcomes after chemotherapy.

Participants experienced low levels of fatigue (2.9-3.5 on a 0-10 scale) and maintained good sleep efficiency (82%-92%), although nighttime awakenings were higher than desired, indicating that behavioral techniques for sleep promotion can be beneficial post-chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence, sleep, and fatigue outcomes after adjuvant breast cancer chemotherapy: results of a feasibility intervention study. Berger, AM., VonEssen, S., Kuhn, BR., et al.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluating occupational performance coaching to support fatigue management for people with multiple sclerosis: A feasibility study. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

The cancer patients' perspective on feasibility of using a fatigue diary and the benefits on self-management: results from a longitudinal study. [2022]

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

Adherence, sleep, and fatigue outcomes after adjuvant breast cancer chemotherapy: results of a feasibility intervention study. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Minimal important differences for fatigue patient reported outcome measures-a systematic review. [2022]

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

Getting patients active: using national data to drive practice. [2014]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A quick assessment of reliable change in fatigue: Reliable change indices of the modified fatigue impact scale - 5 item (MFIS-5). [2021]

7. England pubmed.ncbi.nlm.nih.gov

Lifestyle coaching is feasible in fatigued brain tumor patients: A phase I/feasibility, multi-center, mixed-methods randomized controlled trial. [2023]

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

Cross-sectional relationship of reported fatigue to obesity, diet, and physical activity: results from the third national health and nutrition examination survey. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Internet and smartphone-based ecological momentary assessment and personalized advice (PROfeel) in adolescents with chronic conditions: A feasibility study. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Fatigue related to radiotherapy for breast and/or gynaecological cancer: a systematic review. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Taking fatigue seriously, II: variability in fatigue levels in cancer patients. [2022]