Parkinson DiseaseSocM-PDNCT03938974
Social Self-Management of Parkinson's Disease
An observational study of Parkinson Disease, run by Tufts University at 2 sites in United States.
Trial summary
Parkinson's disease (PD) affects 1% to 2% of the US population over age 60, and its prevalence is increasing as the population ages. The proposed research will establish the natural evolution of the social lives of people with Parkinson's disease and their families and its relationship to health outcomes, and thus has… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 146 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Sep 2013to 31 Mar 2019
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: We recruited People with Parkinson's disease as primary participants (Care partners were enrolled if available) through the Boston University Medical Center Parkinson's Disease and Movement Disorders Clinic, regional Parkinson's disease support groups, older adult service centers, and postings on research and advocacy websites. The neurological medical team conducted and supervised the medical history and screening.
Who may be able to join
- Diagnosis of idiopathic PD utilizing the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria, as evaluated by the neurological team
- Modified Hoehn and Yahr stage 1 through 4
- Score ≥ 26 on the Mini-Mental Status Exam
- Home setting within travel distance to study locations
- Able to communicate clearly and in English with research staff
- Interested in participating and willing and able to provide informed consent
Show all 11Show fewer
- Inclusion Criteria for Care Partners of Participants with Parkinson's Disease:
- Person with PD must consent for care partner to participate
- Score ≥ 26 on the Mini-Mental Status Exam
- Able to communicate clearly and in English with research staff
- Interested in participating and willing and able to provide informed consent
Who cannot join
- Diagnosis of atypical Parkinsonism
- Modified Hoehn and Yahr Stage 5
- Score < 26 on the Mini-Mental Status Exam
- Not able to communicate clearly and in English with research staff
- Exclusion Criteria for Care Partners of Participants with Parkinson's Disease:
- Person with PD does not consent for care partner to participate
- Score < 26 on the Mini-Mental Status Exam
- Not able to communicate clearly and in English with research staff
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Medical Center
Boston, Massachusetts, 02118
Tufts University
Medford, Massachusetts, 02155
About this study
Official title: The Emergence and Evolution of Social Self-Management of Parkinson's Disease
Parkinson's disease (PD) affects 1% to 2% of the US population over age 60, and its prevalence is increasing as the population ages. The proposed research will establish the natural evolution of the social lives of people with Parkinson's disease and their families and its relationship to health outcomes, and thus has the potential to significantly advance Parkinson's disease research and evidence-based neurological nursing and rehabilitation. The project develops the new construct of social self-management of chronic disease and results will inform the development of new interventions aimed at supporting social integration and preventing isolation and loneliness in people living with Parkinson's disease.
Read the detailed description
Parkinson's disease (PD), one of the most common age-related neurodegenerative disorders, affects facial, vocal and trunk muscles. As this progressive decline occurs, an expressive mask descends, limiting the person's ability to communicate emotions and intentions to others, which may give the impression that the person is cold, asocial or apathetic. Thus, as people with PD are living longer and residing in their homes longer, the burden of care-giving is unmitigated by the social and emotional rewards provided by an expressive individual. While this disability has been discussed in the literature, relatively little is known about how adults living with a chronic physical disease such as PD manage their social lives and how an inability to be emotionally expressive can affect social connections. Because social networks have been shown to be crucial to the overall well-being of people living with chronic diseases, research on how expressive capacity affects life trajectories and overall health is critically needed. The overall objective of this project is to understand the emergence and evolution of social self-management trajectories of people living with PD, and this work has the potential to significantly advance PD research and evidence-based neurological nursing and rehabilitation. The investigators will test the central hypothesis that PD expressive capacity predicts systematic change in the pattern of social self-management of PD and quality of life outcomes.
The Specific Aims of this three-year longitudinal study of 120 patients with PD and a maximum of 120 care partners are: 1) Characterize social self-management trajectories of individuals with PD over a three-year period; 2) Estimate the degree to which expressive nonverbal capacity predicts the social self-management trajectory; and 3) Determine the moderating effect of gender on the association between expressive capacity and change in social self-management.
Over the three-year project period, investigators will assess patients with PD and a care partner 14 times each to examine such factors as social participation and management of social activities; social network; and social comfort, general health and well-being. Descriptive analyses will be performed on the total sample and on meaningful demographic and clinical subgroups. This study is designed to have sufficient power to detect changes over time and to detect differences in gender. The investigators' contribution is significant because it will provide evidence to guide the development of interventions aimed at supporting social integration of people living with PD, thus leading to improved overall health. The proposed work is innovative because, to the best of the investigators' knowledge, it is the first to focus on the novel construct of social self-management and does so in a manner that reflects the daily lived experience of PD. Further, the investigators go beyond descriptive evidence to rigorously test hypotheses regarding factors known to contribute to social stigmatization, expressive capacity and gender.
- Conditions
- Parkinson Disease
- Keywords
- self-management, social ecology, biopsychosocial, social participation, everyday living, person-centered, longitudinal
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity Retention Over Time
Activity Card Sort domains of Instrumental Activities of Daily Living, Low- and High-Demand Leisure Activities, and Social Activities.
Measured: 3 Years
The Chronic Illness Resources Survey (CIRS)
The 22-item CIRS, slightly modified for this study. Respondents rate the extent to which each of the 22 items is accessible or used as a resource over the past 6 months on a 1 (not at all) to 5 (a great deal) Likert scale. Subscale scores are created by averaging (possible range 1 to 5), and include the following: Personal Self-Management (3 items); formal institutions and services-- Health Care (3 items), Organizations (3 items), Work (3 items) and Media and Policy (3 items); and informal interpersonal environment-- Family and Friends (3 items) and Neighborhood (3 items). CIRS was modified by changing the wording of "chronic illness" to "health management." Higher scores represent a better outcome (i.e., greater access to and utilization of healthy resources).
Measured: 3 Years
Social Network Composition
Self-reported responses to the following items: having a spouse or partner in the household (yes/no), number and composition of individuals living in the household, total number of children and total number of grandchildren.
Measured: 3 Years
Contact Frequency
How often, on a 0 (not at all) to 7 (very frequently), are participants in contact with the following:
Their most contacted child (if they have children) Their most contacted friend (if they have friends) Their partner in the study (if applicable)
Measured: 3 years
Support Exchange
Rated on a scale from 1 (not at all) to 5 (a great deal), how often do participants give different types of support (Help with Daily Activities, Emotional Support, and Financial Support) to either their partner in the study (if applicable), the members of their household, and people outside of their household.
Measured: 3 Years
Social Isolation Domain of the Nottingham Health Profile (NHP)
The Social Isolation Domain of the NHP is a 5-item measure: loneliness, difficulty contacting people, feeling that they have no one they are close to, difficulty getting along with others, and feeling like a burden. Participants rate their agreement with statements related to social isolation on a scale from 1 (extremely disagree) to 5 (highly agree) and these items are averaged. A higher score is a worse outcome.
Measured: 3 Years
The Positive Social Interaction subscale items of the Medical Outcomes Study: Social Support Survey (MOS)
We modified the wording of the three Positive Social Interaction items in the MOS Social Support Survey to identify positive interaction frequency with the care partner or the person with PD, rather than a non-specific "someone." Our wording is: "How often is each of the following kinds of support available to you from your partner if you need it?" Each item is rated on a 1 (None of the time) to 5 (All of the time) scale, and these items are averaged. A higher score indicates a better outcome.
Measured: 3 Years
The Stigma Scale for Chronic Illness (SSCI)
The 24-item SSCI has two domains: felt stigma and enacted stigma. Felt stigma items assess the emotional experience of stigmatization such as worry, embarrassment and self-blaming. Enacted stigma items assess the perception that people act differently toward the respondent: acting uncomfortable, being unkind, avoiding contact, and unfair treatment. Each domain contains 12 items (which are averaged to create domain scores), rated on a scale from 1 (never) to 5 (always). A total score is calculated by averaging all items. A higher score is a worse outcome and indicates greater stigma.
Measured: 3 Years
The Interpersonal Communication Rating Protocol: Individual Expressive Behavior (Parkinson's Disease Version) (ICRP-IEB)
The 20-item ICRP-IEB is used as the primary measure of the expressive capacity of participants with PD coded from videotaped discussions. Four to ten trained coders rate the videos on a scale from 1 (low) to 5 (high) of the intensity, duration, and frequency of expressive behaviors from the following domains: facial, bodily, vocal, and verbal. Scores are averaged within domains. A higher score is a better outcome and indicates more expressive behaviors.
Measured: 3 Years
Qualitative Self-Management Interview
Self-identified frustrating and satisfying recent events in daily life and how they manage these and similar events. Next, participants describe an activity outside of the home and how they get ready for it and manage PD symptoms to do it. Finally, participants are asked - How would you rate your overall ability to manage participating in your daily life activities? They provide a response on a scale of 1 (not at all effective) to 5 (highly effective). Participants with PD are videotaped and care partners are audiotaped.
In a second management discussion, we bring together the person with PD and the caregiver and ask them to think of an activity outside of the home that they recently did together. The discussion is videotaped with the camera focused only on the participant with PD.
One of the interviews is conducted in participants' homes, midway through the three-year protocol.
Measured: 3 Years
Secondary outcomes (5)
Short Form -12 (SF-12, version 2)
The 12-item SF-12 (version 2) is a self-report measure of functional health and well-being that is a short form of the SF-36. It provides norm-based scores in two domains (physical and mental health), that compare the respondent against population level health. A higher score is better outcome for health.
Measured: 3 Years
The Parkinson's Disease Questionnaire-39 (PDQ-39)
The PDQ-39 assesses life concerns of individuals with PD. It is composed of a summary index and eight domain scores-mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort. Each item is rated on a 0 (never) to 4 (always) scale. A higher score indicates a higher self-perceived frequency of quality of life and health problems in the past month that are due to the disease, with each domain normed to a scale on which 0 indicating never a problem and 100 always a problem. The summary index is the average of the normed domain scores. A higher score is a worse outcome for quality of life.
Measured: 3 years
The Movement Disorder Society Unified Parkinson's Disease Rating Scales (MDS-UPDRS).
The Movement Disorder Society's Unified Parkinson's Disease Rating Scales (MDS-UPDRS) consists of 65 items across four domains: non-motor experiences, motor experiences, a motor examination, and motor complications, rated from 0 (normal) to 4 (severe). Subscales and a total score are calculated by adding items. A higher score is worse outcome and indicates more severe symptoms of Parkinson's disease.
Measured: 3 Years
The Geriatric Depression Scale-15 (GDS)
The GDS consists of 15 yes or no items. The total score is the sum of all items (range: 0 - 15). A higher score is a worse outcome and indicates greater potential for clinical depression.
Measured: 3 Years
The Montreal Cognitive Assessment (MoCA)
The MoCA consists of 30 test items that assess visuospatial and executive functioning, naming, memory, attention, language, abstraction, delayed recall, and orientation. Each correct answer is awarded one point, which are added to create a total score. A higher score is a better outcome and indicates less cognitive impairment.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start23 Sep 2013
- Primary completion28 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (72)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Boston Medical Center
- Responsible party
- Principal investigator, Linda Tickle-Degnen, Tufts University
- Investigators
- Linda Tickle-Degnen, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938974
- Sponsor's protocol ID
- 1212038
- Other IDs
- R01NR013522
- Acronym
- SocM-PD
- Status last verified
- May 2019
- First submitted
- 17 Apr 2019
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alves G, Wentzel-Larsen T, Aarsland D, Larsen JP. Progression of motor impairment and disability in Parkinson disease: a population-based study. Neurology. 2005 Nov 8;65(9):1436-41. doi: 10.1212/01.wnl.0000183359.50822.f2.
PubMed 16275832Ambady N, Koo J, Rosenthal R, Winograd CH. Physical therapists' nonverbal communication predicts geriatric patients' health outcomes. Psychol Aging. 2002 Sep;17(3):443-452. doi: 10.1037/0882-7974.17.3.443.
PubMed 12243386Ambady N, Laplante D, Nguyen T, Rosenthal R, Chaumeton N, Levinson W. Surgeons' tone of voice: a clue to malpractice history. Surgery. 2002 Jul;132(1):5-9. doi: 10.1067/msy.2002.124733.
PubMed 12110787Bogart KR. Is apathy a valid and meaningful symptom or syndrome in Parkinson's disease? A critical review. Health Psychol. 2011 Jul;30(4):386-400. doi: 10.1037/a0022851.
PubMed 21480712Bogart KR, Tickle-Degnen L, Ambady N. Compensatory expressive behavior for facial paralysis: adaptation to congenital or acquired disability. Rehabil Psychol. 2012 Feb;57(1):43-51. doi: 10.1037/a0026904.
PubMed 22369116Bogart KR, Tickle-Degnen L, Joffe MS. Social interaction experiences of adults with Moebius Syndrome: a focus group. J Health Psychol. 2012 Nov;17(8):1212-22. doi: 10.1177/1359105311432491. Epub 2012 Jan 18.
PubMed 22257565Buchman AS, Boyle PA, Wilson RS, Fleischman DA, Leurgans S, Bennett DA. Association between late-life social activity and motor decline in older adults. Arch Intern Med. 2009 Jun 22;169(12):1139-46. doi: 10.1001/archinternmed.2009.135.
PubMed 19546415Buchman AS, Boyle PA, Wilson RS, James BD, Leurgans SE, Arnold SE, Bennett DA. Loneliness and the rate of motor decline in old age: the Rush Memory and Aging Project, a community-based cohort study. BMC Geriatr. 2010 Oct 22;10:77. doi: 10.1186/1471-2318-10-77.
PubMed 20969786Chastin SF, Baker K, Jones D, Burn D, Granat MH, Rochester L. The pattern of habitual sedentary behavior is different in advanced Parkinson's disease. Mov Disord. 2010 Oct 15;25(13):2114-20. doi: 10.1002/mds.23146.
PubMed 20721926Dahodwala N, Siderowf A, Xie M, Noll E, Stern M, Mandell DS. Racial differences in the diagnosis of Parkinson's disease. Mov Disord. 2009 Jun 15;24(8):1200-5. doi: 10.1002/mds.22557.
PubMed 19412929Davis LL, Weaver M, Habermann B. Differential attrition in a caregiver skill training trial. Res Nurs Health. 2006 Oct;29(5):498-506. doi: 10.1002/nur.20138.
PubMed 16977645Duncan RP, Earhart GM. Measuring participation in individuals with Parkinson disease: relationships with disease severity, quality of life, and mobility. Disabil Rehabil. 2011;33(15-16):1440-6. doi: 10.3109/09638288.2010.533245. Epub 2010 Nov 20.
PubMed 21091047Eagly AH. The his and hers of prosocial behavior: an examination of the social psychology of gender. Am Psychol. 2009 Nov;64(8):644-58. doi: 10.1037/0003-066X.64.8.644.
PubMed 19899859Everard KM, Lach HW, Fisher EB, Baum MC. Relationship of activity and social support to the functional health of older adults. J Gerontol B Psychol Sci Soc Sci. 2000 Jul;55(4):S208-12. doi: 10.1093/geronb/55.4.s208.
PubMed 11584883Forsaa EB, Larsen JP, Wentzel-Larsen T, Herlofson K, Alves G. Predictors and course of health-related quality of life in Parkinson's disease. Mov Disord. 2008 Jul 30;23(10):1420-7. doi: 10.1002/mds.22121.
PubMed 18512757
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Emergence and Evolution of Social Self-Management of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03938974
- Acronym / sponsor ID
- SocM-PD / 1212038
- Conditions
- Parkinson Disease
- Keywords
- self-management, social ecology, biopsychosocial, social participation, everyday living, person-centered, longitudinal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Boston Medical Center
- Study start
- 23 Sep 2013 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 6 May 2019 (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.
Parkinson's disease (PD) affects 1% to 2% of the US population over age 60, and its prevalence is increasing as the population ages. The proposed research will establish the natural evolution of the social lives of people with Parkinson's disease and their families and its relationship to health outcomes, and thus has the potential to significantly advance Parkinson's disease research and evidence-based neurological nursing and rehabilitation. The project develops the new construct of social self-management of chronic disease and results will inform the development of new interventions aimed at supporting social integration and preventing isolation and loneliness in people living with Parkinson's disease.
Detailed description
Parkinson's disease (PD), one of the most common age-related neurodegenerative disorders, affects facial, vocal and trunk muscles. As this progressive decline occurs, an expressive mask descends, limiting the person's ability to communicate emotions and intentions to others, which may give the impression that the person is cold, asocial or apathetic. Thus, as people with PD are living longer and residing in their homes longer, the burden of care-giving is unmitigated by the social and emotional rewards provided by an expressive individual. While this disability has been discussed in the literature, relatively little is known about how adults living with a chronic physical disease such as PD manage their social lives and how an inability to be emotionally expressive can affect social connections. Because social networks have been shown to be crucial to the overall well-being of people living with chronic diseases, research on how expressive capacity affects life trajectories and overall health is critically needed. The overall objective of this project is to understand the emergence and evolution of social self-management trajectories of people living with PD, and this work has the potential to significantly advance PD research and evidence-based neurological nursing and rehabilitation. The investigators will test the central hypothesis that PD expressive capacity predicts systematic change in the pattern of social self-management of PD and quality of life outcomes.
The Specific Aims of this three-year longitudinal study of 120 patients with PD and a maximum of 120 care partners are: 1) Characterize social self-management trajectories of individuals with PD over a three-year period; 2) Estimate the degree to which expressive nonverbal capacity predicts the social self-management trajectory; and 3) Determine the moderating effect of gender on the association between expressive capacity and change in social self-management.
Over the three-year project period, investigators will assess patients with PD and a care partner 14 times each to examine such factors as social participation and management of social activities; social network; and social comfort, general health and well-being. Descriptive analyses will be performed on the total sample and on meaningful demographic and clinical subgroups. This study is designed to have sufficient power to detect changes over time and to detect differences in gender. The investigators' contribution is significant because it will provide evidence to guide the development of interventions aimed at supporting social integration of people living with PD, thus leading to improved overall health. The proposed work is innovative because, to the best of the investigators' knowledge, it is the first to focus on the novel construct of social self-management and does so in a manner that reflects the daily lived experience of PD. Further, the investigators go beyond descriptive evidence to rigorously test hypotheses regarding factors known to contribute to social stigmatization, expressive capacity and gender.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We recruited People with Parkinson's disease as primary participants (Care partners were enrolled if available) through the Boston University Medical Center Parkinson's Disease and Movement Disorders Clinic, regional Parkinson's disease support groups, older adult service centers, and postings on research and advocacy websites. The neurological medical team conducted and supervised the medical history and screening.
Key inclusion criteria (11 listed)
- Diagnosis of idiopathic PD utilizing the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria, as evaluated by the neurological team
- Modified Hoehn and Yahr stage 1 through 4
- Score ≥ 26 on the Mini-Mental Status Exam
- Home setting within travel distance to study locations
- Able to communicate clearly and in English with research staff
Key exclusion criteria (8 listed)
- Diagnosis of atypical Parkinsonism
- Modified Hoehn and Yahr Stage 5
- Score < 26 on the Mini-Mental Status Exam
- Not able to communicate clearly and in English with research staff
- Person with PD does not consent for care partner to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Activity Retention Over Time
Time frame: 3 Years
Activity Card Sort domains of Instrumental Activities of Daily Living, Low- and High-Demand Leisure Activities, and Social Activities.
The Chronic Illness Resources Survey (CIRS)
Time frame: 3 Years
The 22-item CIRS, slightly modified for this study. Respondents rate the extent to which each of the 22 items is accessible or used as a resource over the past 6 months on a 1 (not at all) to 5 (a great deal) Likert scale. Subscale scores are created by averaging (possible range 1 to 5), and include the following: Personal Self-Management (3 items); formal institutions and services-- Health Care (3 items), Organizations (3 items), Work (3 items) and Media and Policy (3 items); and informal interpersonal environment-- Family and Friends (3 items) and Neighborhood (3 items). CIRS was modified by changing the wording of "chronic illness" to "health management." Higher scores represent a better outcome (i.e., greater access to and utilization of healthy resources).
Social Network Composition
Time frame: 3 Years
Self-reported responses to the following items: having a spouse or partner in the household (yes/no), number and composition of individuals living in the household, total number of children and total number of grandchildren.
Contact Frequency
Time frame: 3 years
How often, on a 0 (not at all) to 7 (very frequently), are participants in contact with the following: Their most contacted child (if they have children) Their most contacted friend (if they have friends) Their partner in the study (if applicable)
Support Exchange
Time frame: 3 Years
Rated on a scale from 1 (not at all) to 5 (a great deal), how often do participants give different types of support (Help with Daily Activities, Emotional Support, and Financial Support) to either their partner in the study (if applicable), the members of their household, and people outside of their household.
Social Isolation Domain of the Nottingham Health Profile (NHP)
Time frame: 3 Years
The Social Isolation Domain of the NHP is a 5-item measure: loneliness, difficulty contacting people, feeling that they have no one they are close to, difficulty getting along with others, and feeling like a burden. Participants rate their agreement with statements related to social isolation on a scale from 1 (extremely disagree) to 5 (highly agree) and these items are averaged. A higher score is a worse outcome.
The Positive Social Interaction subscale items of the Medical Outcomes Study: Social Support Survey (MOS)
Time frame: 3 Years
We modified the wording of the three Positive Social Interaction items in the MOS Social Support Survey to identify positive interaction frequency with the care partner or the person with PD, rather than a non-specific "someone." Our wording is: "How often is each of the following kinds of support available to you from your partner if you need it?" Each item is rated on a 1 (None of the time) to 5 (All of the time) scale, and these items are averaged. A higher score indicates a better outcome.
The Stigma Scale for Chronic Illness (SSCI)
Time frame: 3 Years
The 24-item SSCI has two domains: felt stigma and enacted stigma. Felt stigma items assess the emotional experience of stigmatization such as worry, embarrassment and self-blaming. Enacted stigma items assess the perception that people act differently toward the respondent: acting uncomfortable, being unkind, avoiding contact, and unfair treatment. Each domain contains 12 items (which are averaged to create domain scores), rated on a scale from 1 (never) to 5 (always). A total score is calculated by averaging all items. A higher score is a worse outcome and indicates greater stigma.
The Interpersonal Communication Rating Protocol: Individual Expressive Behavior (Parkinson's Disease Version) (ICRP-IEB)
Time frame: 3 Years
The 20-item ICRP-IEB is used as the primary measure of the expressive capacity of participants with PD coded from videotaped discussions. Four to ten trained coders rate the videos on a scale from 1 (low) to 5 (high) of the intensity, duration, and frequency of expressive behaviors from the following domains: facial, bodily, vocal, and verbal. Scores are averaged within domains. A higher score is a better outcome and indicates more expressive behaviors.
Qualitative Self-Management Interview
Time frame: 3 Years
Self-identified frustrating and satisfying recent events in daily life and how they manage these and similar events. Next, participants describe an activity outside of the home and how they get ready for it and manage PD symptoms to do it. Finally, participants are asked - How would you rate your overall ability to manage participating in your daily life activities? They provide a response on a scale of 1 (not at all effective) to 5 (highly effective). Participants with PD are videotaped and care partners are audiotaped. In a second management discussion, we bring together the person with PD and the caregiver and ask them to think of an activity outside of the home that they recently did together. The discussion is videotaped with the camera focused only on the participant with PD. One of the interviews is conducted in participants' homes, midway through the three-year protocol.
5 secondary outcomes
Short Form -12 (SF-12, version 2)
Time frame: 3 Years
The Parkinson's Disease Questionnaire-39 (PDQ-39)
Time frame: 3 years
The Movement Disorder Society Unified Parkinson's Disease Rating Scales (MDS-UPDRS).
Time frame: 3 Years
The Geriatric Depression Scale-15 (GDS)
Time frame: 3 Years
The Montreal Cognitive Assessment (MoCA)
Time frame: 3 Years
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 6 May 2019.
- Background: PubMed 16275832Alves G, Wentzel-Larsen T, Aarsland D, Larsen JP. Progression of motor impairment and disability in Parkinson disease: a population-based study. Neurology. 2005 Nov 8;65(9):1436-41. doi: 10.1212/01.wnl.0000183359.50822.f2.
- Background: PubMed 12243386Ambady N, Koo J, Rosenthal R, Winograd CH. Physical therapists' nonverbal communication predicts geriatric patients' health outcomes. Psychol Aging. 2002 Sep;17(3):443-452. doi: 10.1037/0882-7974.17.3.443.
- Background: PubMed 12110787Ambady N, Laplante D, Nguyen T, Rosenthal R, Chaumeton N, Levinson W. Surgeons' tone of voice: a clue to malpractice history. Surgery. 2002 Jul;132(1):5-9. doi: 10.1067/msy.2002.124733.
- Background: PubMed 21480712Bogart KR. Is apathy a valid and meaningful symptom or syndrome in Parkinson's disease? A critical review. Health Psychol. 2011 Jul;30(4):386-400. doi: 10.1037/a0022851.
- Background: PubMed 22369116Bogart KR, Tickle-Degnen L, Ambady N. Compensatory expressive behavior for facial paralysis: adaptation to congenital or acquired disability. Rehabil Psychol. 2012 Feb;57(1):43-51. doi: 10.1037/a0026904.
- Background: PubMed 22257565Bogart KR, Tickle-Degnen L, Joffe MS. Social interaction experiences of adults with Moebius Syndrome: a focus group. J Health Psychol. 2012 Nov;17(8):1212-22. doi: 10.1177/1359105311432491. Epub 2012 Jan 18.
- Background: PubMed 19546415Buchman AS, Boyle PA, Wilson RS, Fleischman DA, Leurgans S, Bennett DA. Association between late-life social activity and motor decline in older adults. Arch Intern Med. 2009 Jun 22;169(12):1139-46. doi: 10.1001/archinternmed.2009.135.
- Background: PubMed 20969786Buchman AS, Boyle PA, Wilson RS, James BD, Leurgans SE, Arnold SE, Bennett DA. Loneliness and the rate of motor decline in old age: the Rush Memory and Aging Project, a community-based cohort study. BMC Geriatr. 2010 Oct 22;10:77. doi: 10.1186/1471-2318-10-77.
- Background: PubMed 20721926Chastin SF, Baker K, Jones D, Burn D, Granat MH, Rochester L. The pattern of habitual sedentary behavior is different in advanced Parkinson's disease. Mov Disord. 2010 Oct 15;25(13):2114-20. doi: 10.1002/mds.23146.
- Background: PubMed 19412929Dahodwala N, Siderowf A, Xie M, Noll E, Stern M, Mandell DS. Racial differences in the diagnosis of Parkinson's disease. Mov Disord. 2009 Jun 15;24(8):1200-5. doi: 10.1002/mds.22557.
- Background: PubMed 16977645Davis LL, Weaver M, Habermann B. Differential attrition in a caregiver skill training trial. Res Nurs Health. 2006 Oct;29(5):498-506. doi: 10.1002/nur.20138.
- Background: PubMed 21091047Duncan RP, Earhart GM. Measuring participation in individuals with Parkinson disease: relationships with disease severity, quality of life, and mobility. Disabil Rehabil. 2011;33(15-16):1440-6. doi: 10.3109/09638288.2010.533245. Epub 2010 Nov 20.
- Individual participant dataSharing planned: Undecided
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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.
Linda Tickle-Degnen, PhD principal investigator
Tufts University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Tufts University 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 11 inclusion and 8 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 6 May 2019. 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?
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?
Activity Retention Over Time (time frame: 3 Years). The study lists 10 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 NCT03938974, which also lists 72 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 6 May 2019.