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| Name | Class |
|---|---|
| The Diamond Endowment Project | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIDEO | Experimental | Participants receive access to video recordings of their clinic visits |
|
| Usual Care | No Intervention | Participants receive usual care (UC), which is their normal clinic visit and written after-visit summary |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HealthPAL | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Cohen, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Paul J Barr, PhD | Dartmouth College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38924779 | Derived | Bratches RWR, Cohen J, Carpenter-Song E, Mistler L, Barr PJ. The Feasibility and Acceptability of Sharing Video Recordings of Amyotrophic Lateral Sclerosis Clinical Encounters With Patients and Their Caregivers: Pilot Randomized Clinical Trial. JMIR Form Res. 2024 Jun 26;8:e57519. doi: 10.2196/57519. |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |