Parkinson DiseaseNCT03381898
Telehealth Allied Health Care With People Who Have Parkinson's Disease Living in Rural Nevada and Wyoming
A study testing Telehealth Exercise, speech therapy, medication management in people with Parkinson Disease, run by University of Wyoming at 2 sites in United States.
Trial summary
The investigators have developed a three-part allied health care intervention to be delivered via telehealth. These interventions are usually provided face-to-face. Telehealth access to healthcare is needed for people with Parkinson's disease living in rural locations, where providers are sparse and long travel times… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Telehealth Exercise, speech therapy, medication management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Nov 2017to 31 May 2019
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Speak English
- Are 30 years or older
- Have been diagnosed with Parkinson's Disease by a primary care provider
- Allow for us to communicate about you to your primary care provider (i.e., physician, nurse practitioner, or physician assistant)
- Can stand alone for 10 min without holding on to anything
- Are taking at least one medication for Parkinson's Disease
- Are willing the participate in an 8-week study
- Will provide your physical address, your phone number, and an emergency contact's phone number for us to use if an emergency occurs during your telehealth session.
Who cannot join
- Have dementia or problems following directions
- Have a medical diagnosis that would limit exercises
- have experienced a fall that required physician evaluation (Emergency Department, urgent care or a hospitalization) within the past year
- Requires an assistive device or person (e.g., cane or walker) for walking, standing, balancing
- Currently use a structured exercise regimen defined as participation in a regular exercise program consisting of more than 60 minutes per week in total
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
University of Wyoming
Laramie, Wyoming, 82070
Kathleen Nagle, LPN, 702-895-1055, kathleen.nagle@unlv.edu
Mary Jo Cooley Hidecker, PhD
- Recruiting
University of Nevada Las Vegas
Las Vegas, Nevada, 89154
Kathleen Nagle, LPN, 702-895-1377, kathleen.nagle@unlv.edu
Merrill Landers, DPT, PhD
About this study
Official title: Decreasing Health Disparities for Parkinson's Disease in Rural Communities: Assessing Feasibility of Coordinated Telehealth to Deliver Allied Health Care of Medication Management, Physical Therapy, and Speech Therapy
The investigators have developed a three-part allied health care intervention to be delivered via telehealth. These interventions are usually provided face-to-face. Telehealth access to healthcare is needed for people with Parkinson's disease living in rural locations, where providers are sparse and long travel times are often not feasible because of weather conditions, as well as the hallmark symptom of Parkinson's disease, movement disorders
Read the detailed description
Parkinson's Disease \& Allied Health. Parkinson's disease (PD), the second most common neurodegenerative disorder affecting more than a million people in the U.S., has no known cause or cure. Persons with PD use prescription medications and behavioral interventions to alleviate key problems such as walking, handling objects, and speaking. Individuals with PD, accessing multidisciplinary allied health care intervention, have shown functional gains. Without these ongoing, coordinated services, persons with PD become even more debilitated, and this can hasten a decline in their quality of life.
Parkinson's Disease \& Rurality. For those in rural areas, there is a critical health disparity. People who live rurally contend with isolation. Wyoming and Nevada's population density are ranked 49th and 42nd. In conjunction with this low population density and mountainous terrain, individuals experience tremendous burdens including traveling long distances to see health care providers with expertise in treating PD. These factors contribute to the struggle of rural Americans with PD to manage this complicated, chronic disease.
Parkinson's Disease \& Telehealth. Telehealth technology has successfully allowed the delivery of neurology care via "virtual house calls" with rural residents with PD. The virtual house call model was determined to be feasible and promising for specialist care in underserved rural areas. However, telehealth delivery of allied health care should also be examined.
Thus, the investigators propose an exploratory Phase 2 Behavioral Clinical Trial to determine feasibility, safety, and signal of efficacy for telehealth coordinated allied health care for persons with Parkinson's disease in rural Wyoming and Nevada. All 20 participants will be in one arm receiving telehealth exercise, speech therapy, and medication management for eight weeks.
Specific Aims:
For persons with Parkinson's disease in rural Wyoming and Nevada, the investigators will:
Aim 1 Test the feasibility of speech therapy, exercise therapy and medication management coordinated through telehealth.
Aim 2 Determine the safety of the coordinated telehealth speech therapy, exercise therapy, and medication management.
Aim 3 Measure signal of efficacy for telehealth outcomes
- Conditions
- Parkinson Disease
- Being tested
- Telehealth Exercise, speech therapy, medication management
- Keywords
- Telehealth, Physical therapy exercise, Speech therapy Lee Silverman voice treatment, Pharmacy medication management
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth Exercise, speech therapy, medication managementBehavioural
Telehealth exercise once per week, speech therapy 4 times per week, medication management once per week
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Coordinated Allied Health | Experimental | rural persons with Parkinson's disease will receive telehealth exercise, speech therapy, medication management for 8 weeks. Exercise, speech therapy, and medication management are usual care for persons with Parkinson's disease. Having the 3 areas coordinated in delivery via telehealth is the new delivery that our aims address Receives: Behavioral: Telehealth Exercise, speech therapy, medication management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1: Feasibility of the 8-week telehealth program
The number of sessions completed and ability to use the necessary technology.
Measured: 8 weeks
Aim 2: Safety of the 8-week telehealth program
The frequency and nature of adverse events during participation of the telehealth program.
Measured: 8 weeks
Aim 3: Change in Signal of efficacy of the telehealth program - overall
The change in quality of life between baseline at the beginning of the study and after the 8 week intervention. In addition, change will also be measured between the end of the 8 week intervention and 18 weeks later (24 weeks from the baseline). This quality of life measures is a self-report, PD-specific Parkinson's Disease Questionnaire 39 (PDQ39). There are 39 items in 8 subsections (mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, bodily discomfort). Each item ranges from 0 (never) to 4 (always). The overall score and subsection scores are calculated by taking the means of each item divided by the total for that section; thus, converting the score into a percentage with higher percentages equating to more disability.
Measured: 0, 8, 24 weeks
Secondary outcomes (6)
Aim 3: Signal of efficacy of the telehealth program - pharmacy
Change in pill count (i.e., how many pills of each prescription are taken) over the period of the study.
Measured: 8, 24 weeks
Aim 3: Signal of efficacy of the telehealth program - physical therapy 1
Change in 30 second Sit-to-Stand test which measures how many times the participant can stand in 30 seconds.
Measured: 0, 8, 24 weeks
Aim 3: Signal of efficacy of the telehealth program - physical therapy 2
Change in Parkinson's Fatigue Scale, which is a self-report measure of fatigue. This scale measures 16 items using a Likert scale with a low score of 16 (low fatigue) and a high score of 80 (high fatigue).
Measured: 0, 8, 24 weeks
Aim 3: Signal of efficacy of the telehealth program - physical therapy 3
Change in Unified Parkinson's Disease Rating Scale II (UPDRS II), which is a self-report of PD-specific motor aspects of experiences of daily living. There are 13 items with scores ranging from 0 (normal) to 4 (severe). Thus, a score of 0 indicates normal function whereas a score of 52 (the highest possible score) suggestive of severe motor deficits with activities of daily living.
Measured: 0, 8, 24 weeks
Aim 3: Signal of efficacy of the telehealth program - speech therapy 1
Change in self-report Communication Effectiveness Scale, which is an 8 question scale using a 4-point likert scale on how the participant social participation is affected by his speech and communication. The scores range from 0 (not effective) to 32 (very effective communication in all situations).
Measured: 0, 8, 24 weeks
Aim 3: Signal of efficacy of the telehealth program - speech therapy 2
Change in Vocal sound level intensity using the Lee Silverman Voice Treatment (LSVT) Companion Software which measures speech intensity. Changes in vocal sound level could range from - 6 decibel (dB) (reduced loudness) to at least + 6dB which is the average change and is perceptually noticeable.
Measured: 0, 8, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start2 Nov 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a feasibility and safety trial of a single arm a telehealth intervention (pharmacy, physical therapy, and speech therapy) to people with Parkinson's disease.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wyoming
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nevada, Las Vegas
- Responsible party
- Sponsor
- Investigators
- Mary Jo Cooley Hidecker, PhD, Principal investigator, University of WyomingMerrill Landers, DPT, Ph.D., Study director, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381898
- Sponsor's protocol ID
- 1003674
- Status last verified
- Dec 2017
- First submitted
- 29 Nov 2017
- Last updated
- 22 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a feasibility study to help determine appropriate individual participant data (IPD) categories
Publications
Ellis T, Katz DI, White DK, DePiero TJ, Hohler AD, Saint-Hilaire M. Effectiveness of an inpatient multidisciplinary rehabilitation program for people with Parkinson disease. Phys Ther. 2008 Jul;88(7):812-9. doi: 10.2522/ptj.20070265. Epub 2008 Apr 24.
PubMed 18436568Mather, M., Jacobsen, L.A., & Pollard, K.M. (2015). Aging in the United Sates. Population Bulletin 70
Sapir S, Ramig L, Fox C. Speech and swallowing disorders in Parkinson disease. Curr Opin Otolaryngol Head Neck Surg. 2008 Jun;16(3):205-10. doi: 10.1097/MOO.0b013e3282febd3a.
PubMed 18475072Atkinson-Clement C, Sadat J, Pinto S. Behavioral treatments for speech in Parkinson's disease: meta-analyses and review of the literature. Neurodegener Dis Manag. 2015;5(3):233-48. doi: 10.2217/nmt.15.16.
PubMed 26107322Allen NE, Sherrington C, Suriyarachchi GD, Paul SS, Song J, Canning CG. Exercise and motor training in people with Parkinson's disease: a systematic review of participant characteristics, intervention delivery, retention rates, adherence, and adverse events in clinical trials. Parkinsons Dis. 2012;2012:854328. doi: 10.1155/2012/854328. Epub 2011 Nov 16.
PubMed 22191077Allen NE, Sherrington C, Paul SS, Canning CG. Balance and falls in Parkinson's disease: a meta-analysis of the effect of exercise and motor training. Mov Disord. 2011 Aug 1;26(9):1605-15. doi: 10.1002/mds.23790. Epub 2011 Jun 14.
PubMed 21674624Davis KL, Edin HM, Allen JK. Prevalence and cost of medication nonadherence in Parkinson's disease: evidence from administrative claims data. Mov Disord. 2010 Mar 15;25(4):474-80. doi: 10.1002/mds.22999.
PubMed 20131374Herd CP, Tomlinson CL, Deane KH, Brady MC, Smith CH, Sackley CM, Clarke CE. Comparison of speech and language therapy techniques for speech problems in Parkinson's disease. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD002814. doi: 10.1002/14651858.CD002814.pub2.
PubMed 22895931Miller N, Noble E, Jones D, Burn D. Life with communication changes in Parkinson's disease. Age Ageing. 2006 May;35(3):235-9. doi: 10.1093/ageing/afj053. Epub 2006 Mar 15.
PubMed 16540492Fox, C.M., & Ramig, L.O. (1997). Vocal sound pressure level and self-perception of speech and voice in men and women with idiopathic parkinson disease. Am J Speech Lang Pathol 6, 85-94
Baumgartner CA, Sapir S, Ramig TO. Voice quality changes following phonatory-respiratory effort treatment (LSVT) versus respiratory effort treatment for individuals with Parkinson disease. J Voice. 2001 Mar;15(1):105-14. doi: 10.1016/s0892-1997(01)00010-8.
PubMed 12269625Ramig LO, Countryman S, O'Brien C, Hoehn M, Thompson L. Intensive speech treatment for patients with Parkinson's disease: short-and long-term comparison of two techniques. Neurology. 1996 Dec;47(6):1496-504. doi: 10.1212/wnl.47.6.1496.
PubMed 8960734Constantinescu G, Theodoros D, Russell T, Ward E, Wilson S, Wootton R. Treating disordered speech and voice in Parkinson's disease online: a randomized controlled non-inferiority trial. Int J Lang Commun Disord. 2011 Jan-Feb;46(1):1-16. doi: 10.3109/13682822.2010.484848.
PubMed 21281410Halpern AE, Ramig LO, Matos CE, Petska-Cable JA, Spielman JL, Pogoda JM, Gilley PM, Sapir S, Bennett JK, McFarland DH. Innovative technology for the assisted delivery of intensive voice treatment (LSVT(R)LOUD) for Parkinson disease. Am J Speech Lang Pathol. 2012 Nov;21(4):354-67. doi: 10.1044/1058-0360(2012/11-0125). Epub 2012 Oct 15.
PubMed 23071195Wight S, Miller N. Lee Silverman Voice Treatment for people with Parkinson's: audit of outcomes in a routine clinic. Int J Lang Commun Disord. 2015 Mar-Apr;50(2):215-25. doi: 10.1111/1460-6984.12132. Epub 2014 Dec 3.
PubMed 25469736
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Health Disparities for Parkinson's Disease in Rural Communities: Assessing Feasibility of Coordinated Telehealth to Deliver Allied Health Care of Medication Management, Physical Therapy, and Speech Therapy
- ClinicalTrials.gov ID
- NCT03381898
- Acronym / sponsor ID
- 1003674
- Conditions
- Parkinson Disease
- Keywords
- Telehealth, Physical therapy exercise, Speech therapy Lee Silverman voice treatment, Pharmacy medication management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of WyomingUniversity, hospital or other
- Collaborators
- University of Nevada, Las Vegas
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 22 Dec 2017 (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.
The investigators have developed a three-part allied health care intervention to be delivered via telehealth. These interventions are usually provided face-to-face. Telehealth access to healthcare is needed for people with Parkinson's disease living in rural locations, where providers are sparse and long travel times are often not feasible because of weather conditions, as well as the hallmark symptom of Parkinson's disease, movement disorders
Detailed description
Parkinson's Disease \& Allied Health. Parkinson's disease (PD), the second most common neurodegenerative disorder affecting more than a million people in the U.S., has no known cause or cure. Persons with PD use prescription medications and behavioral interventions to alleviate key problems such as walking, handling objects, and speaking. Individuals with PD, accessing multidisciplinary allied health care intervention, have shown functional gains. Without these ongoing, coordinated services, persons with PD become even more debilitated, and this can hasten a decline in their quality of life.
Parkinson's Disease \& Rurality. For those in rural areas, there is a critical health disparity. People who live rurally contend with isolation. Wyoming and Nevada's population density are ranked 49th and 42nd. In conjunction with this low population density and mountainous terrain, individuals experience tremendous burdens including traveling long distances to see health care providers with expertise in treating PD. These factors contribute to the struggle of rural Americans with PD to manage this complicated, chronic disease.
Parkinson's Disease \& Telehealth. Telehealth technology has successfully allowed the delivery of neurology care via "virtual house calls" with rural residents with PD. The virtual house call model was determined to be feasible and promising for specialist care in underserved rural areas. However, telehealth delivery of allied health care should also be examined.
Thus, the investigators propose an exploratory Phase 2 Behavioral Clinical Trial to determine feasibility, safety, and signal of efficacy for telehealth coordinated allied health care for persons with Parkinson's disease in rural Wyoming and Nevada. All 20 participants will be in one arm receiving telehealth exercise, speech therapy, and medication management for eight weeks.
Specific Aims:
For persons with Parkinson's disease in rural Wyoming and Nevada, the investigators will:
Aim 1 Test the feasibility of speech therapy, exercise therapy and medication management coordinated through telehealth.
Aim 2 Determine the safety of the coordinated telehealth speech therapy, exercise therapy, and medication management.
Aim 3 Measure signal of efficacy for telehealth outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a feasibility and safety trial of a single arm a telehealth intervention (pharmacy, physical therapy, and speech therapy) to people with Parkinson's disease.
| Arm | Type | Receives |
|---|---|---|
| Telehealth Coordinated Allied Health | Experimental | Behavioral: Telehealth Exercise, speech therapy, medication managementrural persons with Parkinson's disease will receive telehealth exercise, speech therapy, medication management for 8 weeks. Exercise, speech therapy, and medication management are usual care for persons with Parkinson's disease. Having the 3 areas coordinated in delivery via telehealth is the new delivery that our aims address |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Speak English
- Are 30 years or older
- Have been diagnosed with Parkinson's Disease by a primary care provider
- Allow for us to communicate about you to your primary care provider (i.e., physician, nurse practitioner, or physician assistant)
- Can stand alone for 10 min without holding on to anything
Key exclusion criteria (5 listed)
- Have dementia or problems following directions
- Have a medical diagnosis that would limit exercises
- have experienced a fall that required physician evaluation (Emergency Department, urgent care or a hospitalization) within the past year
- Requires an assistive device or person (e.g., cane or walker) for walking, standing, balancing
- Currently use a structured exercise regimen defined as participation in a regular exercise program consisting of more than 60 minutes per week in total
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 |
|---|---|---|
| Telehealth Exercise, speech therapy, medication managementTelehealth exercise once per week, speech therapy 4 times per week, medication management once per week | Behavioural | Telehealth Coordinated Allied Health |
Primary outcome
Aim 1: Feasibility of the 8-week telehealth program
Time frame: 8 weeks
The number of sessions completed and ability to use the necessary technology.
Aim 2: Safety of the 8-week telehealth program
Time frame: 8 weeks
The frequency and nature of adverse events during participation of the telehealth program.
Aim 3: Change in Signal of efficacy of the telehealth program - overall
Time frame: 0, 8, 24 weeks
The change in quality of life between baseline at the beginning of the study and after the 8 week intervention. In addition, change will also be measured between the end of the 8 week intervention and 18 weeks later (24 weeks from the baseline). This quality of life measures is a self-report, PD-specific Parkinson's Disease Questionnaire 39 (PDQ39). There are 39 items in 8 subsections (mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, bodily discomfort). Each item ranges from 0 (never) to 4 (always). The overall score and subsection scores are calculated by taking the means of each item divided by the total for that section; thus, converting the score into a percentage with higher percentages equating to more disability.
6 secondary outcomes
Aim 3: Signal of efficacy of the telehealth program - pharmacy
Time frame: 8, 24 weeks
Aim 3: Signal of efficacy of the telehealth program - physical therapy 1
Time frame: 0, 8, 24 weeks
Aim 3: Signal of efficacy of the telehealth program - physical therapy 2
Time frame: 0, 8, 24 weeks
Aim 3: Signal of efficacy of the telehealth program - physical therapy 3
Time frame: 0, 8, 24 weeks
Aim 3: Signal of efficacy of the telehealth program - speech therapy 1
Time frame: 0, 8, 24 weeks
Aim 3: Signal of efficacy of the telehealth program - speech therapy 2
Time frame: 0, 8, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Background: PubMed 18436568Ellis T, Katz DI, White DK, DePiero TJ, Hohler AD, Saint-Hilaire M. Effectiveness of an inpatient multidisciplinary rehabilitation program for people with Parkinson disease. Phys Ther. 2008 Jul;88(7):812-9. doi: 10.2522/ptj.20070265. Epub 2008 Apr 24.
- BackgroundMather, M., Jacobsen, L.A., & Pollard, K.M. (2015). Aging in the United Sates. Population Bulletin 70
- Background: PubMed 18475072Sapir S, Ramig L, Fox C. Speech and swallowing disorders in Parkinson disease. Curr Opin Otolaryngol Head Neck Surg. 2008 Jun;16(3):205-10. doi: 10.1097/MOO.0b013e3282febd3a.
- Background: PubMed 26107322Atkinson-Clement C, Sadat J, Pinto S. Behavioral treatments for speech in Parkinson's disease: meta-analyses and review of the literature. Neurodegener Dis Manag. 2015;5(3):233-48. doi: 10.2217/nmt.15.16.
- Background: PubMed 22191077Allen NE, Sherrington C, Suriyarachchi GD, Paul SS, Song J, Canning CG. Exercise and motor training in people with Parkinson's disease: a systematic review of participant characteristics, intervention delivery, retention rates, adherence, and adverse events in clinical trials. Parkinsons Dis. 2012;2012:854328. doi: 10.1155/2012/854328. Epub 2011 Nov 16.
- Background: PubMed 21674624Allen NE, Sherrington C, Paul SS, Canning CG. Balance and falls in Parkinson's disease: a meta-analysis of the effect of exercise and motor training. Mov Disord. 2011 Aug 1;26(9):1605-15. doi: 10.1002/mds.23790. Epub 2011 Jun 14.
- Background: PubMed 20131374Davis KL, Edin HM, Allen JK. Prevalence and cost of medication nonadherence in Parkinson's disease: evidence from administrative claims data. Mov Disord. 2010 Mar 15;25(4):474-80. doi: 10.1002/mds.22999.
- Background: PubMed 22895931Herd CP, Tomlinson CL, Deane KH, Brady MC, Smith CH, Sackley CM, Clarke CE. Comparison of speech and language therapy techniques for speech problems in Parkinson's disease. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD002814. doi: 10.1002/14651858.CD002814.pub2.
- Background: PubMed 16540492Miller N, Noble E, Jones D, Burn D. Life with communication changes in Parkinson's disease. Age Ageing. 2006 May;35(3):235-9. doi: 10.1093/ageing/afj053. Epub 2006 Mar 15.
- BackgroundFox, C.M., & Ramig, L.O. (1997). Vocal sound pressure level and self-perception of speech and voice in men and women with idiopathic parkinson disease. Am J Speech Lang Pathol 6, 85-94
- Background: PubMed 12269625Baumgartner CA, Sapir S, Ramig TO. Voice quality changes following phonatory-respiratory effort treatment (LSVT) versus respiratory effort treatment for individuals with Parkinson disease. J Voice. 2001 Mar;15(1):105-14. doi: 10.1016/s0892-1997(01)00010-8.
- Background: PubMed 8960734Ramig LO, Countryman S, O'Brien C, Hoehn M, Thompson L. Intensive speech treatment for patients with Parkinson's disease: short-and long-term comparison of two techniques. Neurology. 1996 Dec;47(6):1496-504. doi: 10.1212/wnl.47.6.1496.
- Individual participant dataSharing planned: No. This is a feasibility study to help determine appropriate individual participant data (IPD) categories
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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.
Mary Jo Cooley Hidecker, PhD principal investigator
University of Wyoming
Merrill Landers, DPT, Ph.D. study director
University of Nevada, Las Vegas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Exercise, speech therapy, medication management in people with Parkinson Disease, run by University of Wyoming at 2 sites 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathleen Nagle, LPN (7028951377, kathleen.nagle@unlv.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1: Feasibility of the 8-week telehealth program (time frame: 8 weeks). 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 NCT03381898, which also lists 41 linked publications.
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 22 Dec 2017.