Amyotrophic Lateral SclerosisNCT04719403
Determining Feasibility and Acceptability of Sharing Video Recordings With Patients With ALS and Caregivers
A study testing HealthPAL in people with Amyotrophic Lateral Sclerosis, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- HealthPAL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2021to 9 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Those without the capacity to provide consent, either themselves or via proxy
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
About this study
Official title: Determining the Feasibility, Acceptability, and Potential Effectiveness of Sharing Video Recordings of Multidisciplinary ALS Clinics With Patients and Their Caregivers
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.
Read the 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).
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- HealthPAL
- Keywords
- neurology, health communications
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthPALOther
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.
| Study group | Role | What they receive |
|---|---|---|
| VIDEO | Experimental | Participants receive access to video recordings of their clinic visits Receives: Other: HealthPAL |
| Usual Care | No intervention | Participants receive usual care (UC), which is their normal clinic visit and written after-visit summary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Enrollment (Feasibility)
Meeting the targeted recruitment number and rate (two patients per month over a 12 month period)
Measured: 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.
Measured: 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
Measured: Three months
Secondary outcomes (14)
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.
Measured: Baseline, one week, three months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Three months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start12 May 2021
- Primary completion9 Jun 2022
- Study completion9 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Diamond Endowment Project
- Responsible party
- Principal investigator, Paul J. Barr, Dartmouth-Hitchcock Medical Center
- Investigators
- Jeffrey Cohen, MD, Principal investigator, Dartmouth-Hitchcock Medical CenterPaul J Barr, PhD, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719403
- Sponsor's protocol ID
- STUDY02000798
- Status last verified
- Feb 2023
- First submitted
- 15 Jan 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38924779
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Feasibility, Acceptability, and Potential Effectiveness of Sharing Video Recordings of Multidisciplinary ALS Clinics With Patients and Their Caregivers
- ClinicalTrials.gov ID
- NCT04719403
- Acronym / sponsor ID
- STUDY02000798
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- neurology, health communications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- The Diamond Endowment Project
- Study start
- 12 May 2021 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIDEO | Experimental | Other: HealthPALParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Those without the capacity to provide consent, either themselves or via proxy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealthPALParticipants 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. | Other | VIDEO |
Primary outcome
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
14 secondary outcomes
Change from baseline in Patient Satisfaction, as measured by the Patient Satisfaction Questionnaire-18 (PSQ-18)
Time frame: Baseline, one week, three months
Change from baseline in adherence to treatment, as measured by the Medical Outcomes Study - General Adherence
Time frame: 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)
Time frame: Baseline, one week, three months
Change from baseline in adherence to physical therapy, as measured by the Exercise Adherence Rating Scale (EARS)
Time frame: Baseline, one week, three months
Change from baseline in anxiety, as measured by the Generalized Anxiety Disorder - 7 (GAD-7)
Time frame: Baseline, three months
Change from baseline in functional status, as measured by the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)
Time frame: Baseline, one week, three months
Change from baseline in depression, as measured by the Patient Health Questionnaire - 8 (PHQ-8)
Time frame: Baseline, three months
Level of Communication in the Visit, as measured by the Interpersonal Processes of Care (IPC)
Time frame: One week
Level of literacy, as measured by the Single Item Literacy Screener
Time frame: Baseline
Change in caregiver burden, as measured by the Burden Scale for Family Caregivers - Short (BSFC-s)
Time frame: Baseline, one week, three months
Change in caregiver preparedness, as measured by the Preparedness for Caregiving Scale
Time frame: Baseline, one week, three months
Change in self-efficacy, as measured by the Self Efficacy for Managing Chronic Disease scale
Time frame: Baseline, one week, three months
Feasibility of the Intervention, as measured by the Feasibility of Intervention Metric (FIM)
Time frame: Three months from baseline
Acceptability of the Intervention, as measured by the Acceptability of Intervention Metric (AIM)
Time frame: Three months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Derived from this study: PubMed 38924779Bratches 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Cohen, MD principal investigator
Dartmouth-Hitchcock Medical Center
Paul J Barr, PhD principal investigator
Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HealthPAL in people with Amyotrophic Lateral Sclerosis, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Enrollment (Feasibility) (time frame: Study Completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04719403, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.