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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-12

Study Completion Date

2022-06-09

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.

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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).

Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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VIDEO

Participants receive access to video recordings of their clinic visits

Group Type EXPERIMENTAL

HealthPAL

Intervention Type OTHER

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.

Usual Care

Participants receive usual care (UC), which is their normal clinic visit and written after-visit summary

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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HealthPAL

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.

Intervention Type OTHER

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