Telehealth Pilot for Veterans With Chronic Multi-Symptom Illness.

Study Overview
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Brief Summary
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The objective of this study is to examine the effectiveness of a telehealth intervention intended to augment several factors related to brain health and cognition in Veterans with chronic multi-symptom illness.

Detailed Description
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The objective of this study is to examine the effectiveness of a telehealth intervention intended to augment several factors related to brain health and cognition in Veterans with chronic multi-symptom illness. This pilot study innovatively merges with ongoing clinical practice at the War Related Illness and Injury Study Center to explore if utilizing new VA technologies and distance-bridging approaches can improve executive function by promoting health behaviors (e.g. physical activity and mindfulness meditation, called mental and physical training or MAP). Not only does this study intend to examine the feasibility of using these tools within the home setting and integrating these practices into the weekly lives of Veterans, but it also aims to determine the best way to provide this type of intervention by comparing a text-message based directed MAP (dMAP) arm to a self-guided MAP (sgMAP) arm. Understanding how much guidance to provide Veterans during their path towards recovery is important since we hope that this pilot study will offer not only evidence that these practices can be administered without supervision but also reveal that giving Veterans the right tools (exercise and meditation app on tablet), guidance (directed text message or holistic goals), and support (video-chat health coaching) can have measurable benefits on symptom severity and function.

Official Title
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Enhancing Executive Function and Self-regulation Success Through the Promotion of Brain Health Behaviors: A Telehealth Pilot Study for Veterans With Chronic Multi-symptom Illness.

Conditions
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Chronic Multisymptom Illness

Intervention / Treatment
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* Behavioral: Directed instruction of the combined intervention of physical activity and mindfulness meditation
* Behavioral: Self-guided practice of the combined intervention of physical activity and mindfulness meditation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veterans who are National Referral Program patients and undergoing clinical care at the DC War Related Illness and Injury Study Center. Local and previously enrolled National Referral Program patients. Veterans who were deployed with Chronic Multisymptom Illness. Able to engage in physical activity No current or previous drug use past 90 days. No excessive alcohol consumption No current prominent suicide or homicidal ideation No recent exposure to trauma No acute or unstable illness No dementia or significant cognitive impairments Exclusion Criteria: AUDIT Score >= 4 (men) AUDIT Score >= 3 (women) Current or previous drug use past 90 days. Excessive alcohol consumption Current prominent suicide or homicidal ideation Recent exposure to trauma Acute or unstable illness Dementia or significant cognitive impairments

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self-Guided<br>Participant's do not receive text message direction from the VA Annie Text Messaging System. Participant's create their own method for accomplishing app-based exercise and mindfulness practice without detailed instructions. | Behavioral: Self-guided practice of the combined intervention of physical activity and mindfulness meditation<br>* The participants will receive the same goals about exercise and mindfulness practice, but without the added text messages where explicit instruction will be provided<br>|
| Experimental: Directed Messaging<br>Participant's receive text message directions from the ANNIE VA messaging system. The directed messaging system provides text message details of the participant's app-based meditation and exercise instructions. | Behavioral: Directed instruction of the combined intervention of physical activity and mindfulness meditation<br>* By using the VA's ANNIE text messaging systems, the participant's will receive detailed guidance on the exercise and mindfulness session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) | Administering the Change in the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) at three time points to assess executive function and self-regulation. | Administered at Baseline, End of the 8 week intervention, and 3-month follow up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Physical Activity Questionnaire (IPAQ) | To measure the physical activity of an individual on a variety of domains (Job Related Physical Activity, Transportation Physical Activity, Housework, House Maintenance, and Caring for Family, Recreation, Sport, and Leisure-Time Physical Activity, Time Spent Sitting). | Administered at Baseline, End of the 8 week intervention, and 3-month follow up. | 
| Five-Factor Mindfulness Questionnaire(FFMQ) | To assess the 5 domains of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. | Administered at Baseline, End of the 8 week intervention, and 3-month follow up. | 
| Pittsburgh Sleep Quality Index (PSQI) | To measure the quality and patterns of sleep in adults | Administered at Baseline, End of the 8 week intervention, and 3-month follow up. | 
| Patient Health Questionnaire- Depression scale (PHQ-9) | To be used for screening, diagnosing, monitoring, and measuring the severity of depression | Administered at Baseline, End of the 8 week intervention, and 3-month follow up. | 
| Posttraumatic Symptom Checklist - Military version(PCL-M) | To evaluate the severity of PTSD symptoms in an individual who has had military experience | Administered at Baseline, End of the 8 week intervention, and 3-month follow up. | 
| Perceived Stress Scale (PSS) | To measure the perception of stress | Administered at Baseline, End of the 8 week intervention, and 3-month follow up. | 
| Brief Symptom Inventory | To evaluate psychological distress and psychiatric disorders | Administered at Baseline, End of the 8 week intervention, and 3-month follow up. | 
| Patient Outcomes Measurement Information System (PROMIS) | The PROMIS is a patient reported neuropsych measure that assesses pain interference, fatigue, and global health levels of an individual by using the subscales: PROMIS pain interference, PROMIS fatigue, and PROMIS global health scale. | Administered at Baseline and End of the 8 week intervention | 
| Medical Outcomes Study Short-Form-36 (SF-36v2) | To indicate the overall health status of an individual in eight sections: Vitality, Physical Functioning, Bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health | Administered at Baseline, End of the 8 week intervention, and 3-month follow up. | 
| Neuro quality of life (QOL) | To assess quality of life in various domains (Anxiety, Depression, Fatigue, Upper Extremity Function-Fine Motor, ADL, Lower Extremity Function-Mobility, Applied Cognition-Executive Function, Applied Cognition-General Concerns, Emotional and Behavioral Dyscontrol, Positive Affect and Wellbeing, Sleep Disturbance, Ability to participate in social roles and activities, Satisfaction with social roles and activities, stigma, and communication) and sub-domains for adults with neurological disorders | Administered at Baseline and End of the 8 week intervention | 
| Cognitive Difficulties Scale (CDS) | To assess seven factors cognitions: Distraction, Activities of Daily Living, Prospective Memory, Long-term Memory, Orientation, Language, and Fine Motor control. | Administered at Baseline, End of the 8 week intervention, and 3-month follow up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telehealth, Veterans, Exercise, Mindfulness, Health Coaching