Determining Feasibility and Acceptability of Sharing Video Recordings With Patients With ALS and Caregivers

Study Overview
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Brief Summary
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Our objective in the proposed project is to: (a) operationalize and determine the feasibility and acceptability of a trial where clinic multi-disciplinary clinic (MDC) visits are audio/video recorded and shared with patients with ALS and their caregivers; (b) gather preliminary data examining the impact of routinely adding audio/video recordings of clinic visits to UC on self-management ability and other behavioral, health and health services outcomes at baseline (T0) and other regular interviews from enrollment (T1= 1 Week, T2= 3 Months); and (c) identify factors pertinent to the acceptability of our study protocol and the audio/video recording of visits.

Detailed Description
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We will conduct a single-site, two-arm, parallel group, patient-randomized, controlled, pilot trial with 3-month follow up, to determine the feasibility, acceptability, and potential effectiveness of sharing audio/video recordings of multidisciplinary ALS clinics with patients and their caregivers. We will recruit 24 patients with ALS and their caregivers over a recruitment period of 1 year. We are primarily interested in determining the feasibility of the trial and acceptability of the audio/video intervention. We will also explore the impact on the patients' ability to self-manage their care as well as exploratory outcomes, at baseline (T0 = pre-visit), at T1 (1 week), and at T2 (3 months).

Official Title
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Determining the Feasibility, Acceptability, and Potential Effectiveness of Sharing Video Recordings of Multidisciplinary ALS Clinics With Patients and Their Caregivers

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Other: HealthPAL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed and primarily treated for Amyotrophic Lateral Sclerosis (ALS) Aged 18 years or greater Can communicate in English (verbally, on a computer, or with assistance) Have email Have internet access Willing to have their multidisciplinary clinic visit audio/video recorded for a 3 month period Exclusion Criteria: Those without the capacity to provide consent, either themselves or via proxy

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 |
| --- | --- |
| Experimental: VIDEO<br>Participants receive access to video recordings of their clinic visits | Other: HealthPAL<br>* Participants who are randomly assigned to the HealthPAL arm will have immediate post- visit access to audio/video-recordings of their clinical visit through a HIPAA-compliant web-based program called HealthPAL.<br>|
| No Intervention: Usual Care<br>Participants receive usual care (UC), which is their normal clinic visit and written after-visit summary | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Enrollment (Feasibility) | Meeting the targeted recruitment number and rate (two patients per month over a 12 month period) | Study Completion, an average of 1 year | 
| Intervention Fidelity (Feasibility) | The proportion of ALS MDC (multidisciplinary clinic) patients in the intervention arm that received the VIDEO intervention with full adherence to a pre-defined protocol fidelity checklist. Any deviations will be documented. | Three months | 
| Patient use of the Intervention (Acceptability) | The proportion of ALS MDC (multidisciplinary clinic) patients in the intervention arm who used the recording between the day of receipt and the three-month follow up | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Patient Satisfaction, as measured by the Patient Satisfaction Questionnaire-18 (PSQ-18) | Scores are measured on an 18-item, 5-level scale, with a score of 1 indicating strongly agree and a score of 5 indicating Strongly Disagree. Scores range from 18 to 90, with lower scores indicating higher levels of satisfaction. | Baseline, one week, three months | 
| Change from baseline in adherence to treatment, as measured by the Medical Outcomes Study - General Adherence | Scores are measured on a 5-item, 6-level scale, with a score of 1 indicating None of the time and a score of 6 indicating All of the time. Scores range from 6 to 30, with higher scores indicating higher levels of adherence. Items 1 and 3 are scored in reverse. | Baseline, one week, three months | 
| Change from baseline in adherence to medications, as measured by the Adherence to Refills and Medications Scale - 7 (ARMS-7) | Scores are measured on a 7-item, 4-level scale, with a score of 1 indicating None and a score of 4 indicating All. Scores range from 7 to 28, with lower scores indicating higher levels of adherence. | Baseline, one week, three months | 
| Change from baseline in adherence to physical therapy, as measured by the Exercise Adherence Rating Scale (EARS) | Scores are measured on a 6-item, 5-level scale, with 0 indicating Completely agree and 4 indicating Completely disagree. Scores range from 0 to 30, where a higher score indicates a higher level of adherence. | Baseline, one week, three months | 
| Change from baseline in anxiety, as measured by the Generalized Anxiety Disorder - 7 (GAD-7) | Scores are based on a 7-item, 4-level scale with 0 indicating Not at all and 3 indicating Nearly every day. Higher scores indicate higher levels of anxiety. | Baseline, three months | 
| Change from baseline in functional status, as measured by the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) | Scores are measured on a 13-item, 5-level scale, with 0 indicating low function and 4 indicating high functioning, and one item as yes/no. Scores range from 0 to 48, with high scores indicating higher levels of functioning. | Baseline, one week, three months | 
| Change from baseline in depression, as measured by the Patient Health Questionnaire - 8 (PHQ-8) | Scores are based on a 8-item, 4-level scale with 0 indicating Not at all and 3 indicating Nearly every day. Higher scores indicate higher levels of depression. | Baseline, three months | 
| Level of Communication in the Visit, as measured by the Interpersonal Processes of Care (IPC) | Scores are based on an 18-item, 5-level scale with 1 indicating Never and 5 indicating Always. Scores range from 18 to 90, with higher scores indicating higher levels of communication. | One week | 
| Level of literacy, as measured by the Single Item Literacy Screener | Scores are measured on a single item, 5-level scale. Scores range from 1 to 5, with higher scores indicating higher levels of literacy. | Baseline | 
| Change in caregiver burden, as measured by the Burden Scale for Family Caregivers - Short (BSFC-s) | Scores are based on a 10-item, 4-level scale, with 0 indicating strongly disagree and 3 indicating strongly agree. Scores range from 0 to 30, with higher scores indicate higher levels of burden. | Baseline, one week, three months | 
| Change in caregiver preparedness, as measured by the Preparedness for Caregiving Scale | Scores are based on a 9-item, 5-level scale, with 0 indicating not at all prepared, and 4 indicating very well prepared. Scores range from 0 to 45, with higher scores indicating higher levels of preparedness. | Baseline, one week, three months | 
| Change in self-efficacy, as measured by the Self Efficacy for Managing Chronic Disease scale | Scores are measured on 6x 10-item scales. Scores range from 0 to 60, with higher scores indicating higher levels of self-efficacy. | Baseline, one week, three months | 
| Feasibility of the Intervention, as measured by the Feasibility of Intervention Metric (FIM) | Scores are measured on a 4-item, 5-level scale, with a score of 1 indicating completely disagree and 5 indicating completely agree. Scores range from 4 to 20, with higher scores indicating higher levels of feasibility. | Three months from baseline | 
| Acceptability of the Intervention, as measured by the Acceptability of Intervention Metric (AIM) | Scores are measured on a 4-item, 5-level scale, with a score of 1 indicating completely disagree and 5 indicating completely agree. Scores range from 4 to 20, with higher scores indicating higher levels of acceptability. | Three months from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurology, health communications