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Social Self-Management of Parkinson's Disease (SocM-PD)

2 maja 2019 zaktualizowane przez: Linda Tickle-Degnen, Tufts University

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.

Przegląd badań

Status

Zakończony

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

146

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02118
        • Boston Medical Center
      • Medford, Massachusetts, Stany Zjednoczone, 02155
        • Tufts University

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

Inclusion Criteria for People with Parkinson's Disease:

  1. Diagnosis of idiopathic PD utilizing the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria, as evaluated by the neurological team
  2. Modified Hoehn and Yahr stage 1 through 4
  3. Score ≥ 26 on the Mini-Mental Status Exam
  4. Home setting within travel distance to study locations
  5. Able to communicate clearly and in English with research staff
  6. Interested in participating and willing and able to provide informed consent

Inclusion Criteria for Care Partners of Participants with Parkinson's Disease:

  1. Person with PD must consent for care partner to participate
  2. Score ≥ 26 on the Mini-Mental Status Exam
  3. Able to communicate clearly and in English with research staff
  4. Interested in participating and willing and able to provide informed consent

Exclusion Criteria for People with Parkinson's Disease:

  1. Diagnosis of atypical Parkinsonism
  2. Modified Hoehn and Yahr Stage 5
  3. Score < 26 on the Mini-Mental Status Exam
  4. Not able to communicate clearly and in English with research staff

Exclusion Criteria for Care Partners of Participants with Parkinson's Disease:

  1. Person with PD does not consent for care partner to participate
  2. Score < 26 on the Mini-Mental Status Exam
  3. Not able to communicate clearly and in English with research staff

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Activity Retention Over Time
Ramy czasowe: 3 Years
Activity Card Sort domains of Instrumental Activities of Daily Living, Low- and High-Demand Leisure Activities, and Social Activities.
3 Years
The Chronic Illness Resources Survey (CIRS)
Ramy czasowe: 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).
3 Years
Social Network Composition
Ramy czasowe: 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.
3 Years
Contact Frequency
Ramy czasowe: 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)
3 years
Support Exchange
Ramy czasowe: 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.
3 Years
Social Isolation Domain of the Nottingham Health Profile (NHP)
Ramy czasowe: 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.
3 Years
The Positive Social Interaction subscale items of the Medical Outcomes Study: Social Support Survey (MOS)
Ramy czasowe: 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.
3 Years
The Stigma Scale for Chronic Illness (SSCI)
Ramy czasowe: 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.
3 Years
The Interpersonal Communication Rating Protocol: Individual Expressive Behavior (Parkinson's Disease Version) (ICRP-IEB)
Ramy czasowe: 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.
3 Years
Qualitative Self-Management Interview
Ramy czasowe: 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.
3 Years

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Short Form -12 (SF-12, version 2)
Ramy czasowe: 3 Years
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.
3 Years
The Parkinson's Disease Questionnaire-39 (PDQ-39)
Ramy czasowe: 3 years
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.
3 years
The Movement Disorder Society Unified Parkinson's Disease Rating Scales (MDS-UPDRS).
Ramy czasowe: 3 Years
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.
3 Years
The Geriatric Depression Scale-15 (GDS)
Ramy czasowe: 3 Years
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.
3 Years
The Montreal Cognitive Assessment (MoCA)
Ramy czasowe: 3 Years
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.
3 Years

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Tufts University

Współpracownicy

National Institute of Nursing Research (NINR)
Boston Medical Center

Śledczy

  • Główny śledczy: Linda Tickle-Degnen, PhD, Tufts University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

23 września 2013

Zakończenie podstawowe (Rzeczywisty)

28 marca 2019

Ukończenie studiów (Rzeczywisty)

31 marca 2019

Daty rejestracji na studia

Pierwszy przesłany

17 kwietnia 2019

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 maja 2019

Pierwszy wysłany (Rzeczywisty)

6 maja 2019

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 maja 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 maja 2019

Ostatnia weryfikacja

1 maja 2019

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 1212038
  • R01NR013522 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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