Clinical trial NCT04719403: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: neurology
health communications
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: The Diamond Endowment Project
First posted: 2021-01-22
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: Patient Enrollment (Feasibility)
timeFrame: Study Completion, an average of 1 year
measure: Intervention Fidelity (Feasibility)
timeFrame: Three months
measure: Patient use of the Intervention (Acceptability)
timeFrame: Three months
Secondary outcomes:
measure: Change from baseline in Patient Satisfaction, as measured by the Patient Satisfaction Questionnaire-18 (PSQ-18)
timeFrame: Baseline, one week, three months
measure: Change from baseline in adherence to treatment, as measured by the Medical Outcomes Study - General Adherence
timeFrame: Baseline, one week, three months
measure: Change from baseline in adherence to medications, as measured by the Adherence to Refills and Medications Scale - 7 (ARMS-7)
timeFrame: Baseline, one week, three months
measure: Change from baseline in adherence to physical therapy, as measured by the Exercise Adherence Rating Scale (EARS)
timeFrame: Baseline, one week, three months
measure: Change from baseline in anxiety, as measured by the Generalized Anxiety Disorder - 7 (GAD-7)
timeFrame: Baseline, three months
measure: Change from baseline in functional status, as measured by the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)
timeFrame: Baseline, one week, three months
measure: Change from baseline in depression, as measured by the Patient Health Questionnaire - 8 (PHQ-8)
timeFrame: Baseline, three months
measure: Level of Communication in the Visit, as measured by the Interpersonal Processes of Care (IPC)
timeFrame: One week
measure: Level of literacy, as measured by the Single Item Literacy Screener
timeFrame: Baseline
measure: Change in caregiver burden, as measured by the Burden Scale for Family Caregivers - Short (BSFC-s)
timeFrame: Baseline, one week, three months
measure: Change in caregiver preparedness, as measured by the Preparedness for Caregiving Scale
timeFrame: Baseline, one week, three months
measure: Change in self-efficacy, as measured by the Self Efficacy for Managing Chronic Disease scale
timeFrame: Baseline, one week, three months
measure: Feasibility of the Intervention, as measured by the Feasibility of Intervention Metric (FIM)
timeFrame: Three months from baseline
measure: Acceptability of the Intervention, as measured by the Acceptability of Intervention Metric (AIM)
timeFrame: Three months from baseline
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Jeffrey Cohen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth College
name: Paul J Barr, PhD
role: PRINCIPAL_INVESTIGATOR
References: