A Patient Centric Motor Neuron Disease Activities of Daily Living Scale
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| ClinicalTrials.gov Identifier: NCT02852278 |
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Recruitment Status :
Enrolling by invitation
First Posted : August 2, 2016
Last Update Posted : September 27, 2018
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| Condition or disease | Intervention/treatment |
|---|---|
| Amyotrophic Lateral Sclerosis Progressive Muscular Atrophy Primary Lateral Sclerosis Hereditary Spastic Paraplegia | Other: Web-based Survey |
The patient activities of daily living for amyotrophic lateral sclerosis survey (PADL-ALS, Appendix B) is a patient-centric revision of the standard revised ALS functional rating scale used in clinical trials, the ALSFRS-R. The PADL-ALS was developed based on patient interviews, and patient focus groups. The ALSFRS-R is made up of 12 categories detailing various activities of daily living and includes six bulbar-respiratory functions, three upper extremity functions (writing, cutting food, and dressing), and three gross motor functions (walking, climbing, and turning in bed). Each activity is recorded to the closest approximation from a list of five choices, scored 0-4, with the total score ranging from 48 (normal function) to 0 (no function). The PADL-ALS includes questions from the ALSFRS-R, with revisions to make the questions easier to understand. In addition the PADL-ALS contains a question about pain; a question about emotional lability; and a general non-denominational question about faith. The survey will be composed of two parts, the initial survey, and then monthly follow up surveys. The initial survey will include the PADL-ALS with additional questions about symptom onset, date of diagnosis, initial region involved, patient impression of diagnosis, general demographic questions (age, gender, race, ethnicity, education), and medications related to their diagnosis of motor neuron disease.
The survey data will be stored by the Rare Diseases Clinical Research Network's Data Management and Coordinating Center (DMCC) at the University of South Florida. Upon conclusion of the study period, the data will be sent to Jeffrey Statland, MD, University of Kansas Medical Center (Study Chair) and Michael Benatar, MD, PhD, University of Miami (CReATe Consortium PI). All data collected will be sent to the database of Genotypes and Phenotypes (dbGaP) to be stored indefinitely.
| Study Type : | Observational |
| Estimated Enrollment : | 356 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | A Patient Centric Motor Neuron Disease Activities of Daily Living Scale |
| Actual Study Start Date : | December 2016 |
| Estimated Primary Completion Date : | June 12, 2019 |
| Estimated Study Completion Date : | June 12, 2019 |
- Other: Web-based Survey
This is a prospective 12-month study of patients with motor neuron disease enrolled in CReATe Connect, an RDCRN Contact Registry.
- PADL-ALS Survey [ Time Frame: 12 months ]The PADL-ALS survey is a revision of the ALSFR-R, which consists of 12 categories detailing various activities of daily living and includes six bulbar-respiratory functions, three upper extremity functions (writing, cutting food, and dressing) and three gross motor functions (walking, climbing, and turning in bed). Each activity is recorded from a list of five choices, scored 0-4, with the total score ranging from 48 (normal function) to 0 (no function). The PADL-ALS includes questions from the ALSFRS-R, with revisions for easier understanding. The PADL-ALS also includes questions about pain, emotional lability and a general non-denominational question about faith. The survey is composed of an initial survey and monthly follow up surveys. The initial survey will include additional questions about symptom onset, date of diagnosis, initial region involved, patient impression of diagnosis, general demographic questions, and medications related to their diagnosis of motor neuron disease.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Self-reported diagnosis of motor neuron disease (amyotrophic lateral sclerosis, amyotrophic lateral sclerosis - frontotemporal dementia, primary lateral sclerosis, progressive muscular atrophy, or hereditary spastic paraplegia)
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Enrolled in CReATe Connect, an RDCRN Contact Registry
o Individuals of any age, race, ethnicity, and from any location will be able to participate
- Participants will need to be able to fill out the survey in English
Exclusion Criteria:
• Inability to provide informed consent and complete survey
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852278
| Principal Investigator: | Jeffrey Statland, MD | University of Kansas Medical Center | |
| Principal Investigator: | Michael Benatar, MD, PhD | University of Miami | |
| Principal Investigator: | Jeffery Krischer, PhD | University of South Florida, Data Management Coordinating Center | |
| Principal Investigator: | Callyn Kirk, MSPH | University of South Florida |
Publications of Results:
Other Publications:
| Responsible Party: | University of South Florida |
| ClinicalTrials.gov Identifier: | NCT02852278 History of Changes |
| Other Study ID Numbers: |
CReATe 8003 U01TR001263 ( U.S. NIH Grant/Contract ) |
| First Posted: | August 2, 2016 Key Record Dates |
| Last Update Posted: | September 27, 2018 |
| Last Verified: | September 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by University of South Florida:
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Amyotrophic Lateral Sclerosis ALS motor neuron diseases |
Progressive Muscular Atrophy Primary Lateral Sclerosis Hereditary Spastic Paraplegia |
Additional relevant MeSH terms:
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Sclerosis Atrophy Motor Neuron Disease Amyotrophic Lateral Sclerosis Muscular Atrophy Muscle Spasticity Paraplegia Spastic Paraplegia, Hereditary Muscular Atrophy, Spinal Pathologic Processes Pathological Conditions, Anatomical Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases Spinal Cord Diseases |
Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases Neuromuscular Manifestations Neurologic Manifestations Signs and Symptoms Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Paralysis Hereditary Sensory and Motor Neuropathy Nervous System Malformations Heredodegenerative Disorders, Nervous System Polyneuropathies |