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

NCT04719403 | Completed

• 1 other identifier: STUDY02000798
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

neurology; health communications

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (14)

• Change from baseline in Patient Satisfaction, as measured by the Patient Satisfaction Questionnaire-18 (PSQ-18)

  Baseline, one week, three months

• Change from baseline in adherence to treatment, as measured by the Medical Outcomes Study - General Adherence

  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)

  Baseline, one week, three months

• Change from baseline in adherence to physical therapy, as measured by the Exercise Adherence Rating Scale (EARS)

  Baseline, one week, three months

• Change from baseline in anxiety, as measured by the Generalized Anxiety Disorder - 7 (GAD-7)

  Baseline, three months

Study Arms (2)

VIDEO

EXPERIMENTAL

Participants receive access to video recordings of their clinic visits

Other: HealthPAL

Usual Care

NO INTERVENTION

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

Interventions

HealthPAL 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.

VIDEO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Those without the capacity to provide consent, either themselves or via proxy

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• The Diamond Endowment Project: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Related Publications (1)

• Bratches RWR, Cohen J, Carpenter-Song E, Mistler L, Barr PJ. The Feasibility and Acceptability of Sharing Video Recordings of Amyotrophic Lateral Sclerosis Clinical Encounters With Patients and Their Caregivers: Pilot Randomized Clinical Trial. JMIR Form Res. 2024 Jun 26;8:e57519. doi: 10.2196/57519.

  PMID: 38924779 DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jeffrey Cohen, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

• Paul J Barr, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, The Dartmouth Institute for Health Policy and Clinical Practice

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 22, 2021
• Study Start: May 12, 2021
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)