NCT04719403

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2021-05-12
• Primary completion: 2022-06-09
• Completion: 2022-06-09
• First posted: 2021-01-22
• Last updated: 2023-02-21

Locations

1 site across 1 country: United States