Planning and Incentives for Traumatic Brain Injury

Overseen By Timothy Morris, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northeastern University

Must not be taking: CNS medications

Disqualifiers: Severe TBI, Neurological condition, others

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

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether different behavioral interventions can improve walking habits in older adults who have experienced a mild or moderate traumatic brain injury (TBI). Participants will either receive health education or engage in planning, reminders, and small incentives to encourage walking over a 12-week period. This trial suits those who have had a mild to moderate TBI in the last 3 months to 15 years and can exercise without assistance. Participants must engage with study staff weekly and use a Fitbit to track their progress. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance recovery strategies for TBI patients.

Will I have to stop taking my current medications?

The trial requires that participants are not currently on any medication that affects the central nervous system. If you are taking such medications, you may need to stop them to participate.

What prior data suggests that these behavioral interventions are safe for older adults with TBI?

Research shows that the types of behavioral treatments under study are generally safe for people with traumatic brain injuries (TBI). Studies have found that these treatments can improve thinking skills and overall health without causing harm. For example, one study used a Fitbit to encourage more physical activity and found that participants could safely increase their weekly steps without any serious side effects. Another review demonstrated that physical activity is safe and beneficial for people with TBI, aiding both short- and long-term recovery. Overall, these findings suggest that the treatments in this study are safe and well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to managing traumatic brain injury (TBI) through a combination of planning, reminders, and micro-incentives. Unlike standard treatments, which often focus on medications and physical therapies, this method emphasizes behavioral strategies to enhance patient engagement and adherence to recovery plans. By incorporating micro-incentives and personalized reminders, the trial aims to improve long-term outcomes by motivating patients to actively participate in their recovery process. This innovative approach could revolutionize how we support TBI patients, offering a more tailored and proactive care model.

What evidence suggests that this trial's behavioral interventions could be effective for improving walking behaviors in older adults with TBI?

This trial will compare two approaches to aid recovery in individuals with traumatic brain injuries (TBI). One arm will focus on "Planning, Reminders, and Micro-Incentives," which research suggests helps people with TBI become more adaptable, improve brain function, and reduce impulsive behavior. The other arm will involve "Health Education," including exercise programs like walking. Studies have shown that such programs increase happiness, improve sleep, and enhance quality of life for TBI patients. For instance, a walking program using a Fitbit helped participants increase their weekly steps by 40%, demonstrating that tracking activity and motivation encourages more exercise. Overall, these methods offer a promising way to aid recovery and improve daily life for those with TBI. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for older adults who have had a mild or moderate non-penetrating traumatic brain injury (TBI). They must be able to exercise, not on central nervous system medications, and willing to attend baseline testing at Northeastern University. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

Signed Informed consent

Men and women of all ethnicities/races and socio-economic status

Physically fit enough to undergo exercise as screened using the Physical Activity Readiness Questionnaire (PAR-Q) and the cardiovascular section of the Health History & Demographics Questionnaire

Exclusion Criteria

Not MRI compatible

Not medically cleared for exercise

I am not fluent in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (phone call)

Baseline Assessment

Participants undergo baseline testing including MRI and cognitive assessments

1 session

1 visit (in-person)

Treatment

Participants receive behavioral interventions over 12 weeks, including weekly phone calls and wearing a Fit Bit

12 weeks

12 visits (phone calls)

Follow-up

Participants complete post-testing remotely, including cognitive tasks and questionnaires

1 week

Remote participation

What Are the Treatments Tested in This Trial?

Interventions

• Health Education
• Planning, Reminders, and Micro-Incentives

Trial Overview The study compares the effectiveness of a special program with planning, reminders, and small rewards against standard health education in increasing physical activity over 12 weeks. Participants will use FitBit trackers and record their walking activities.

How Is the Trial Designed?

Group I: Planning, Reminders, and Micro-Incentives Experimental Treatment 1 Intervention

Group II: Health Education Active Control 1 Intervention

Who Is Running the Clinical Trial?

Northeastern University

Lead Sponsor

Trials

103

Recruited

72,600+

Timothy Morris

Lead Sponsor

Trials

1

Recruited

60+

Brandeis University

Collaborator

Trials

22

Recruited

14,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Health education initiatives have been shown to effectively change health behaviors, contributing to improved health outcomes, although the specific mechanisms behind this success are not fully understood.

Incorporating preventive services into patient care, especially for high-risk individuals, can enhance the effectiveness of health education efforts, highlighting the growing focus on preventive care in primary healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education for health. A role for physicians and the efficacy of health education efforts. Council on Scientific Affairs. [2016]

Health care interventions, like computerized order entry systems, can lead to new types of errors, as providers may depend too much on default information instead of consulting proper guidelines.

To improve the effectiveness of health care interventions, it's important to measure how patients and physicians behave in response to these interventions, as this can help explain why some logical solutions don't work as well in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Peltzman effect and compensatory markers in medicine. Prasad, V., Jena, AB.[2019]

Many incentive programs aimed at improving patient self-care are unlikely to be effective because they rely on patients having the necessary information, expertise, and self-control, which many do not possess.

Incorporating behavioral economics insights, such as providing small, frequent payments for positive health behaviors like medication adherence, can enhance the effectiveness of these programs and improve patient engagement, benefiting both patients and insurers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral economics holds potential to deliver better results for patients, insurers, and employers. Loewenstein, G., Asch, DA., Volpp, KG.[2022]

In a study involving 24 clients with traumatic brain injury (TBI), the introduction of monetary incentives significantly improved memory performance across three different memory tasks compared to conditions without rewards.

These findings support the author's incentive-based model of cognitive retraining, suggesting that rewards can enhance cognitive function in individuals with TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of monetary incentives on performance after traumatic brain injury. Parenté, R.[2014]

A collaborative process involving researchers, individuals with traumatic brain injury, and health professionals led to the development of a survey that identifies physical activity preferences for people with moderate-to-severe traumatic brain injury, refining 17 initial attributes down to six key factors.

The co-development process enhanced the survey's relevance and clarity, addressing challenges in recruitment and communication, which could be beneficial for similar studies in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Preferences of People Living with Brain Injury: Formative Qualitative Research to Develop a Discrete Choice Experiment. Haynes, A., Howard, K., Johnson, L., et al.[2023]

Participants with traumatic brain injury (TBI) reported an average of 2.25 barriers to physical activity (PA) and completed about 46 minutes of PA weekly, indicating that while barriers exist, some level of activity is achievable.

Those in the 'action' and 'maintenance' stages of PA participation engaged in significantly more activity compared to those in earlier stages, highlighting the importance of readiness to change in promoting physical activity among TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What barriers to physical activity do individuals with a recent brain injury face? Driver, S., Ede, A., Dodd, Z., et al.[2016]

A study involving 116 participants with mild-to-moderate traumatic brain injury found that a combined cognitive and vocational intervention (CCT-SE) was more cost-effective from a societal perspective compared to treatment as usual (TAU), primarily due to lower productivity loss costs.

While the CCT-SE intervention resulted in higher healthcare costs, it led to a quicker return to work, with an incremental cost-effectiveness ratio of €56 per day earlier back to work, indicating its potential benefits in reducing overall societal costs associated with TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness analysis of combined cognitive and vocational rehabilitation in patients with mild-to-moderate TBI: results from a randomized controlled trial. Howe, EI., Andelic, N., Fure, SCR., et al.[2022]

The Dynamic Computer Interactive Decision Application (DCIDA) was developed to help patients make better health decisions by addressing common cognitive errors, and preliminary testing with 20 participants showed it was reasonably usable and useful.

Participants using DCIDA spent 21% more time focusing on the most important features of their decisions, and 25% changed their preferred option, indicating that the application may enhance the quality of decision-making in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and preliminary user testing of the DCIDA (Dynamic computer interactive decision application) for 'nudging' patients towards high quality decisions. Bansback, N., Li, LC., Lynd, L., et al.[2022]

Incentive-based interventions that promote healthy behaviors, such as exercise and smoking cessation, are becoming more common in healthcare settings and can significantly impact health outcomes.

Behavior analytic research provides valuable insights that can help healthcare providers design effective incentive-based interventions tailored to encourage specific healthy behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ABCs of incentive-based treatment in health care: a behavior analytic framework to inform research and practice. Meredith, SE., Jarvis, BP., Raiff, BR., et al.[2021]

A systematic review of six studies on cue-reminders in health-risk behavior interventions showed mixed results, with one study indicating a small positive effect and another a medium negative effect.

Overall, the evidence is inconclusive regarding the effectiveness of cue-reminders in enhancing health-risk behavior interventions, suggesting that more research is needed to determine their true impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cue-Reminders to Prevent Health-Risk Behaviors: A Systematic Review. van Leeuwen, L., Onrust, S., van den Putte, B., et al.[2020]

Behaviour Change Interventions (BCIs) and Patient Decision Aids (PtDAs) have distinct goals and methods but can be integrated to enhance health-related decision-making and behavior change for individuals.

The integration of insights from both BCIs and PtDAs could improve patient engagement and help individuals set and achieve health goals that align with their personal values and preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating behaviour change interventions and patient decision aids: How to accomplish synergistic effects? Gültzow, T., Hoving, C., Smit, ES., et al.[2023]

Health interventions developed over the last 20 years show substantial effectiveness, with average effect sizes of 0.46 for primary prevention and 0.49 for secondary prevention and patient education, based on meta-analyses of various studies.

The effectiveness of these interventions can be enhanced by systematically applying social science theories in their development and incorporating learning principles like rewards and feedback, as well as strategies to facilitate behavior change, such as reminders and financial incentives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of health education and health promotion: meta-analyses of effect studies and determinants of effectiveness. Kok, G., van den Borne, B., Mullen, PD.[2019]

Understanding non-compliance in individuals with traumatic brain injury (TBI) involves considering factors like memory deficits, cultural background, and personal interests, which can influence their participation in treatment.

Using techniques like consequence management and antecedent control can effectively promote engagement in therapy, highlighting the importance of recognizing each individual's unique preferences and pre-injury lifestyle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing and treating non-compliance in brain-injured clients. Zencius, AH., Lane, I., Wesolowski, MD.[2019]

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