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

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ClinicalTrials.gov Identifier: NCT04719403
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : June 30, 2021
Sponsor:
Collaborator:
The Diamond Endowment Project
Information provided by (Responsible Party):
Paul J. Barr, Dartmouth-Hitchcock Medical Center

Brief Summary:
The purpose of the study is to demonstrate the feasibility and acceptability of routine sharing of clinic video recordings with patients and caregivers.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Other: HealthPAL Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Determining the Feasibility, Acceptability, and Potential Effectiveness of Sharing Video Recordings of Multidisciplinary ALS Clinics With Patients and Their Caregivers
Actual Study Start Date : May 12, 2021
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022


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



Primary Outcome Measures :
  1. 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)

  2. 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.

  3. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04719403


Contacts
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Contact: Reed WR Bratches, MPH 6312591504 reed.w.bratches.gr@dartmouth.edu
Contact: Susan M Tarczewski 603-646-7066 susan.m.tarczewski@dartmouth.edu

Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03766
Contact: Reed WR Bratches, MPH    631-259-1504    reed.w.bratches.gr@dartmouth.edu   
Contact: Susan Tarczewski    603-646-7066    susan.m.tarczewski@dartmouth.edu   
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
The Diamond Endowment Project
Investigators
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Principal Investigator: Jeffrey Cohen, MD Dartmouth-Hitchcock Medical Center
Principal Investigator: Paul J Barr, PhD Dartmouth College
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Responsible Party: Paul J. Barr, Associate Professor, The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT04719403    
Other Study ID Numbers: STUDY02000798
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paul J. Barr, Dartmouth-Hitchcock Medical Center:
neurology
health communications
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases