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

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 Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Other: HealthPAL

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).

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VIDEO; Participants receive access to video recordings of their clinic visits	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.
No Intervention: Usual Care; Participants receive usual care (UC), which is their normal clinic visit and written after-visit summary

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: The Diamond Endowment Project
• Investigators: Principal Investigator: Jeffrey Cohen, MD, Dartmouth-Hitchcock Medical Center; Principal Investigator: Paul J Barr, PhD, Dartmouth College

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2021
• Primary Completion (Actual): June 9, 2022
• Study Completion (Actual): June 9, 2022

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: neurology; health communications
• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: STUDY02000798

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No