Determining the Feasibility, Acceptability, and Potential Effectiveness of Sharing Video Recordings of Multidisciplinary ALS Clinics With Patients and Their Caregivers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Amyotrophic Lateral Sclerosis
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- Patient Enrollment (Feasibility)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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).
Investigators
Paul J. Barr
Associate Professor, The Dartmouth Institute for Health Policy and Clinical Practice
Dartmouth-Hitchcock Medical Center
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
- Change from baseline in functional status, as measured by the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)(Baseline, one week, three months)
- Change from baseline in depression, as measured by the Patient Health Questionnaire - 8 (PHQ-8)(Baseline, three months)
- Level of Communication in the Visit, as measured by the Interpersonal Processes of Care (IPC)(One week)
- Level of literacy, as measured by the Single Item Literacy Screener(Baseline)
- Change in caregiver burden, as measured by the Burden Scale for Family Caregivers - Short (BSFC-s)(Baseline, one week, three months)
- Change in caregiver preparedness, as measured by the Preparedness for Caregiving Scale(Baseline, one week, three months)
- Change in self-efficacy, as measured by the Self Efficacy for Managing Chronic Disease scale(Baseline, one week, three months)
- Feasibility of the Intervention, as measured by the Feasibility of Intervention Metric (FIM)(Three months from baseline)
- Acceptability of the Intervention, as measured by the Acceptability of Intervention Metric (AIM)(Three months from baseline)