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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Determining the Feasibility, Acceptability, and Potential Effectiveness of Sharing Video Recordings of Multidisciplinary ALS Clinics With Patients and Their Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04719403
• Other study ID #: STUDY02000798
• Status: Completed
• Phase: N/A
• Start date: May 12, 2021
• Est. completion date: June 9, 2022

Study information

• Verified date: February 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: June 9, 2022
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

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.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	The Diamond Endowment Project

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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