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

• ClinicalTrials.gov Identifier: NCT04719403
• Recruitment Status: Completed
• First Posted: January 22, 2021
• Last Update Posted: February 21, 2023
• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborator: The Diamond Endowment Project
• Information provided by (Responsible Party): Paul J. Barr, Dartmouth-Hitchcock Medical Center

Tracking Information

• First Submitted Date: January 15, 2021
• First Posted Date: January 22, 2021
• Last Update Posted Date: February 21, 2023
• Actual Study Start Date: May 12, 2021
• Actual Primary Completion Date: June 9, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 20, 2021)

• Patient Enrollment (Feasibility) [ Time Frame: Study Completion, an average of 1 year ]
  Meeting the targeted recruitment number and rate (two patients per month over a 12 month period)
• Intervention Fidelity (Feasibility) [ Time Frame: Three months ]
  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.
• Patient use of the Intervention (Acceptability) [ Time Frame: Three months ]
  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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 20, 2021)

• Change from baseline in Patient Satisfaction, as measured by the Patient Satisfaction Questionnaire-18 (PSQ-18) [ Time Frame: Baseline, one week, three months ]
  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.
• Change from baseline in adherence to treatment, as measured by the Medical Outcomes Study - General Adherence [ Time Frame: Baseline, one week, three months ]
  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.
• Change from baseline in adherence to medications, as measured by the Adherence to Refills and Medications Scale - 7 (ARMS-7) [ Time Frame: Baseline, one week, three months ]
  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.
• Change from baseline in adherence to physical therapy, as measured by the Exercise Adherence Rating Scale (EARS) [ Time Frame: Baseline, one week, three months ]
  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.
• Change from baseline in anxiety, as measured by the Generalized Anxiety Disorder - 7 (GAD-7) [ Time Frame: Baseline, three months ]
  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.
• Change from baseline in functional status, as measured by the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) [ Time Frame: Baseline, one week, three months ]
  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.
• Change from baseline in depression, as measured by the Patient Health Questionnaire - 8 (PHQ-8) [ Time Frame: Baseline, three months ]
  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.
• Level of Communication in the Visit, as measured by the Interpersonal Processes of Care (IPC) [ Time Frame: One week ]
  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.
• Level of literacy, as measured by the Single Item Literacy Screener [ Time Frame: Baseline ]
  Scores are measured on a single item, 5-level scale. Scores range from 1 to 5, with higher scores indicating higher levels of literacy.
• Change in caregiver burden, as measured by the Burden Scale for Family Caregivers - Short (BSFC-s) [ Time Frame: Baseline, one week, three months ]
  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.
• Change in caregiver preparedness, as measured by the Preparedness for Caregiving Scale [ Time Frame: Baseline, one week, three months ]
  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.
• Change in self-efficacy, as measured by the Self Efficacy for Managing Chronic Disease scale [ Time Frame: Baseline, one week, three months ]
  Scores are measured on 6x 10-item scales. Scores range from 0 to 60, with higher scores indicating higher levels of self-efficacy.
• Feasibility of the Intervention, as measured by the Feasibility of Intervention Metric (FIM) [ Time Frame: Three months from baseline ]
  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.
• Acceptability of the Intervention, as measured by the Acceptability of Intervention Metric (AIM) [ Time Frame: Three months from baseline ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Determining Feasibility and Acceptability of Sharing Video Recordings With Patients With ALS and Caregivers
• Official Title: Determining the Feasibility, Acceptability, and Potential Effectiveness of Sharing Video Recordings of Multidisciplinary ALS Clinics With Patients and Their Caregivers
• 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.
• 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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: Amyotrophic Lateral Sclerosis

Intervention

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.

Study Arms

• Experimental: VIDEO
  Participants receive access to video recordings of their clinic visits
  Intervention: Other: HealthPAL
• No Intervention: Usual Care
  Participants receive usual care (UC), which is their normal clinic visit and written after-visit summary

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 17, 2023): 79
• Original Estimated Enrollment (submitted: January 20, 2021): 58
• Actual Study Completion Date: June 9, 2022
• Actual Primary Completion Date: June 9, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04719403
• Other Study ID Numbers: STUDY02000798
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Paul J. Barr, Dartmouth-Hitchcock Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Dartmouth-Hitchcock Medical Center
• Original Study Sponsor: Same as current
• Collaborators: The Diamond Endowment Project

Investigators

• Principal Investigator: Jeffrey Cohen, MD; Dartmouth-Hitchcock Medical Center
• Principal Investigator: Paul J Barr, PhD; Dartmouth College

• PRS Account: Dartmouth-Hitchcock Medical Center
• Verification Date: February 2023