Study Purpose:
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.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
N/A
Intervention Name:
HealthPAL
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Jeffrey Cohen, MD, Dartmouth-Hitchcock Medical Center, Paul J Barr, PhD, Dartmouth College
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Full Study Summary:
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).
Study Sponsor:
Dartmouth-Hitchcock Medical Center
Estimated Enrollment:
79
Estimated Study Start Date:
05 / 12 / 2021
Estimated Study Completion Date:
06 / 09 / 2022
Posting Last Modified Date:
02 / 21 / 2023
Date Study Added to neals.org:
01 / 22 / 2021
Minimum Age:
18 Years
Maximum Age:
N/A
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
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire
03766
United States