Parkinson's Disease and ParkinsonismNCT06074393
Caregiving in Advanced PD: A Tailored Support Group
A study testing Tailored Support Group in people with Parkinson's Disease and Parkinsonism, run by University of Calgary at 1 site in Canada.
Trial summary
The goal of this study is to understand how support groups can help people who care for individuals with Parkinson's Disease and Related Disorders (PDRD). The investigators want to find answers to these questions: How do these support groups make caregivers feel? Do these support groups help caregivers cope better and… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease and Parkinsonism
- What is being tested?
- Tailored Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 19 Oct 2023to 31 Oct 2024
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Care partners of individuals with a confirmed diagnosis of Parkinsonian Syndrome.
- Participants in the Calgary Movement Disorders Advanced Care pilot program (REB22-0545)
Who cannot join
- Care partners with significant cognitive impairments that hinder participation with MoCA<10 points.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Health Science Centre, University of Calgary
Calgary, Alberta, T2N 4N1
Veronica Bruno, 4032107542, veronica.bruno@ucalgary.ca
Karla Cantu Flores, 4032107542, karla.cantuflores@ucalgary.ca
About this study
Official title: Caregiving in Advanced Parkinsonian Disease: A Tailored Support Group
The goal of this study is to understand how support groups can help people who care for individuals with Parkinson's Disease and Related Disorders (PDRD). The investigators want to find answers to these questions:
- How do these support groups make caregivers feel?
- Do these support groups help caregivers cope better and improve their quality of life?
Read more
Participants in this study will join support groups where they can talk to other caregivers and learn from experts. These groups will meet every two weeks for four months, and there will be sessions on different topics like self-care, coping skills, and mindfulness. Caregivers will share their experiences and ask questions in these sessions.
Information will be collected before and after the support group meetings using surveys. These surveys will help understand how the support groups affect caregivers. Things like caregiver burden, coping strategies, and overall well-being will be measured.
The main goal is to reduce the burden on caregivers of people with PDRD and improve their quality of life. It is believed that these support groups can make a positive difference, and this study will help understand how they work.
Read the detailed description
Background \& Rationale:
Neurodegenerative diseases are projected to surpass cancer as the leading cause of death by 2030. Parkinson's disease prevalence in Canada was 170/100,000 in 2013/2014, and with an aging population, the number of Canadians over 40 with the disease will rise by 65% by 2030. Advanced stages of Parkinson's Disease and Related Disorders (PDRD) result in motor disability and complex non-motor symptoms, increasing demand for healthcare services. Care partners face challenges such as anxiety, managing treatments, and uncertainty, leading to negative lifestyle changes and reduced mental health.
Care partners of PDRD must manage stressors that impact their health and well-being. Existing support groups mainly focus on disease management, and neglecting care partner challenges. These pilot support groups provide an avenue for emotional and informational support, addressing care partner burdens. Structured meetings offer practical tools, solutions, and guest speakers, enhancing support group content.
Research Question \& Objectives
The study aims to establish and assess support groups tailored to PDRD care partners' needs with two main objectives:
Creating a supportive environment through structured meetings. Evaluating support group effectiveness in enhancing coping, reducing burden, and improving quality of life.
Methods:
Study Design:
The study is structured around the establishment of a supportive community for individuals caring for PDRD. The primary objective is to foster connections among caregivers, enabling them to exchange personal experiences and derive shared comfort from others who comprehend the challenges associated with these conditions.
Participants engage in a secure and confidential environment, sharing narratives and insights that contribute to their collective knowledge of effective caregiving. Moreover, the support group incorporates dedicated sessions led by healthcare experts encompassing various disciplines, including physicians, nurses, psychologists, social workers, and spiritual advisors. These specialized sessions, each lasting 90 minutes, occur biweekly over a 16-week period. Hosted at the University of Calgary's Cumming School of Medicine in a hybrid structure by using Zoom as a method of assistance, these sessions occur twice annually, accentuating the recurrent and structured nature of the support group.
In each week various themes will be addressed, such as:
Self-care and Personal Health Adaptation to changes in the living situation, changing roles and navigating the system Coping skills and Resilience Emotions (embracing vulnerability, emotional identification, factual validation, counteraction, problem resolution).
Anticipatory grief Forgiveness and interconnectedness Mindfulness Establishing boundaries, attaining tranquility, and achieving closure In every session of the support group, care partners are encouraged to participate by sharing their experiences, as well as asking pertinent questions.
Data Collection:
The study employs pre- and post-participation questionnaires and measurement instruments to assess support group efficacy comprehensively using Qualtrics as a data collection tool for the surveys.
Instruments include:
Short Zarit Burden Interview (ZBI-12) to quantify caregiving impact. Brief-COPE to assess coping mechanisms. Adult Carer Quality of Life Questionnaire (AC-QoL) to measure overall well-being.
Satisfaction Survey to gather participant feedback and knowledge acquisition.
Outcomes:
Primary Outcomes:
Care Partner Burden: Assessed using ZBI-12. Coping Strategies: Evaluated with Brief-COPE scale. Quality of Life: Scrutinized using AC-QoL scale.
Secondary Outcomes:
Satisfaction with Participation: Caregiver Support Group Satisfaction Survey
The study addresses the increasing burden on care partners of individuals with PDRD. It establishes and evaluates support groups tailored to their needs to enhance coping, reduce burden, and improve quality of life. The study utilizes structured meetings, measurement instruments, and comprehensive assessments to shed light on the effects of the support groups on care partners' well-being.
- Conditions
- Parkinson's Disease and Parkinsonism
- Being tested
- Tailored Support Group
- Keywords
- Support group, Care partners
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Support GroupBehavioural
Also called Support Group
Participants engage in a secure, confidential environment, sharing caregiving insights and knowledge. Expert-led sessions, lasting 90 minutes, occur biweekly for 16 weeks, held via Zoom and at the University of Calgary's Cumming School of Medicine. These sessions take place twice annually, emphasizing the structured nature of the support group. Weekly themes include self-care, adaptation, coping skills, emotions, anticipatory grief, forgiveness, mindfulness, boundaries, and closure. Care partners actively participate by sharing experiences and asking questions in each session.
| Study group | Role | What they receive |
|---|---|---|
| Care partners of patients with advanced Parkinsonian Syndromes | Experimental | Care partners of patients with advanced Parkinsonian Syndromes will participate in a tailored support group Receives: Behavioral: Tailored Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Care Partner Burden: Assessed using ZBI-12.
ZBI-12 is validated as a screening tool for advanced illness. The ZBI-12 is rated on a 12 items scale, with the severity of burden using a range of responses from 0 to 4 points per item and a total score range of 0 to 48. Scoring 0-10 is considered as a no to mild burden; 10-20, a mild to moderate burden and >20, a high burden. It measures changes in physical, emotional, social, and financial problems that can be experienced by family caregivers.
Measured: Enrollment and at the end of the Support Group. 1 and 16 weeks.
Changes in Coping Strategies: Evaluated with Brief-COPE scale.
The Brief COPE (Coping Orientation to Problems Experienced) scale, composed of 28 items, each rated on a 4-point scale where 3 represents the highest score, exhibits a minimum value of 0 and a maximum value of 84. When interpreting Brief COPE scores, higher values are indicative of a potentially enhanced capacity to navigate stress and handle challenging situations. These elevated scores reflect a greater propensity to employ diverse coping strategies when confronted with difficulties.
Measured: Enrollment and at the end of the Support Group. 1 and 16 weeks.
Changes in Quality of Life: Scrutinized using AC-QoL scale.
The Adult Carer Quality of Life (AC-QoL) Scale encompasses both an overall scale and eight subscales. The overall scale yields scores ranging from 0 to 120, with higher scores signifying an enhanced quality of life for caregivers. Additionally, each of the eight subscales offers scores within a potential range of 0 to 15. Higher scores on these subscales indicate an improved quality of life for caregivers in specific domains pertaining to their caregiving responsibilities. This structured assessment provides valuable insights into the well-being of caregivers across multiple dimensions of their lives.
Measured: Enrollment and at the end of the Support Group. 1 and 16 weeks.
Secondary outcomes (1)
Satisfaction with Participation: Caregiver Support Group Satisfaction Survey
The Caregiver Support Group Satisfaction Survey is composed of a combination of six multiple-choice questions and three open-ended questions. Each of the six multiple-choice questions is evaluated on a scale ranging from 1 to 5, with 1 signifying the lowest level of satisfaction and 5 indicating the highest level of satisfaction. Consequently, the survey's maximum achievable score is 30, while the minimum score is 5. A higher score on this survey reflects an increased level of satisfaction with the support group, providing valuable feedback on the quality of support and services offered to caregivers.
Measured: Byweekly for 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start19 Oct 2023 (estimated)
- Primary completion19 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease and ParkinsonismStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The clinical trial is a prospective study analysing the effect of a tailored support group on care partner burden, coping strategies, and quality of life in care partners of patients with advanced Parkinsonian syndromes.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veronica Bruno, University of Calgary
- Investigators
- Veronica Bruno, MD, MPH, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074393
- Sponsor's protocol ID
- REB23-0949
- Status last verified
- Oct 2023
- First submitted
- 28 Sep 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiving in Advanced Parkinsonian Disease: A Tailored Support Group
- ClinicalTrials.gov ID
- NCT06074393
- Acronym / sponsor ID
- REB23-0949
- Conditions
- Parkinson's Disease and Parkinsonism
- Keywords
- Support group, Care partners
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 19 Oct 2023 (estimated)
- Primary completion
- 19 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 10 Oct 2023 (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 goal of this study is to understand how support groups can help people who care for individuals with Parkinson's Disease and Related Disorders (PDRD). The investigators want to find answers to these questions:
- How do these support groups make caregivers feel?
- Do these support groups help caregivers cope better and improve their quality of life?
Participants in this study will join support groups where they can talk to other caregivers and learn from experts. These groups will meet every two weeks for four months, and there will be sessions on different topics like self-care, coping skills, and mindfulness. Caregivers will share their experiences and ask questions in these sessions.
Information will be collected before and after the support group meetings using surveys. These surveys will help understand how the support groups affect caregivers. Things like caregiver burden, coping strategies, and overall well-being will be measured.
The main goal is to reduce the burden on caregivers of people with PDRD and improve their quality of life. It is believed that these support groups can make a positive difference, and this study will help understand how they work.
Detailed description
Background \& Rationale:
Neurodegenerative diseases are projected to surpass cancer as the leading cause of death by 2030. Parkinson's disease prevalence in Canada was 170/100,000 in 2013/2014, and with an aging population, the number of Canadians over 40 with the disease will rise by 65% by 2030. Advanced stages of Parkinson's Disease and Related Disorders (PDRD) result in motor disability and complex non-motor symptoms, increasing demand for healthcare services. Care partners face challenges such as anxiety, managing treatments, and uncertainty, leading to negative lifestyle changes and reduced mental health.
Care partners of PDRD must manage stressors that impact their health and well-being. Existing support groups mainly focus on disease management, and neglecting care partner challenges. These pilot support groups provide an avenue for emotional and informational support, addressing care partner burdens. Structured meetings offer practical tools, solutions, and guest speakers, enhancing support group content.
Research Question \& Objectives
The study aims to establish and assess support groups tailored to PDRD care partners' needs with two main objectives:
Creating a supportive environment through structured meetings. Evaluating support group effectiveness in enhancing coping, reducing burden, and improving quality of life.
Methods:
Study Design:
The study is structured around the establishment of a supportive community for individuals caring for PDRD. The primary objective is to foster connections among caregivers, enabling them to exchange personal experiences and derive shared comfort from others who comprehend the challenges associated with these conditions.
Participants engage in a secure and confidential environment, sharing narratives and insights that contribute to their collective knowledge of effective caregiving. Moreover, the support group incorporates dedicated sessions led by healthcare experts encompassing various disciplines, including physicians, nurses, psychologists, social workers, and spiritual advisors. These specialized sessions, each lasting 90 minutes, occur biweekly over a 16-week period. Hosted at the University of Calgary's Cumming School of Medicine in a hybrid structure by using Zoom as a method of assistance, these sessions occur twice annually, accentuating the recurrent and structured nature of the support group.
In each week various themes will be addressed, such as:
Self-care and Personal Health Adaptation to changes in the living situation, changing roles and navigating the system Coping skills and Resilience Emotions (embracing vulnerability, emotional identification, factual validation, counteraction, problem resolution).
Anticipatory grief Forgiveness and interconnectedness Mindfulness Establishing boundaries, attaining tranquility, and achieving closure In every session of the support group, care partners are encouraged to participate by sharing their experiences, as well as asking pertinent questions.
Data Collection:
The study employs pre- and post-participation questionnaires and measurement instruments to assess support group efficacy comprehensively using Qualtrics as a data collection tool for the surveys.
Instruments include:
Short Zarit Burden Interview (ZBI-12) to quantify caregiving impact. Brief-COPE to assess coping mechanisms. Adult Carer Quality of Life Questionnaire (AC-QoL) to measure overall well-being.
Satisfaction Survey to gather participant feedback and knowledge acquisition.
Outcomes:
Primary Outcomes:
Care Partner Burden: Assessed using ZBI-12. Coping Strategies: Evaluated with Brief-COPE scale. Quality of Life: Scrutinized using AC-QoL scale.
Secondary Outcomes:
Satisfaction with Participation: Caregiver Support Group Satisfaction Survey
The study addresses the increasing burden on care partners of individuals with PDRD. It establishes and evaluates support groups tailored to their needs to enhance coping, reduce burden, and improve quality of life. The study utilizes structured meetings, measurement instruments, and comprehensive assessments to shed light on the effects of the support groups on care partners' well-being.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The clinical trial is a prospective study analysing the effect of a tailored support group on care partner burden, coping strategies, and quality of life in care partners of patients with advanced Parkinsonian syndromes.
| Arm | Type | Receives |
|---|---|---|
| Care partners of patients with advanced Parkinsonian Syndromes | Experimental | Behavioral: Tailored Support GroupCare partners of patients with advanced Parkinsonian Syndromes will participate in a tailored support group |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Care partners of individuals with a confirmed diagnosis of Parkinsonian Syndrome.
- Participants in the Calgary Movement Disorders Advanced Care pilot program (REB22-0545)
Key exclusion criteria (1 listed)
- Care partners with significant cognitive impairments that hinder participation with MoCA<10 points.
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 |
|---|---|---|
| Tailored Support GroupAlso: Support GroupParticipants engage in a secure, confidential environment, sharing caregiving insights and knowledge. Expert-led sessions, lasting 90 minutes, occur biweekly for 16 weeks, held via Zoom and at the University of Calgary's Cumming School of Medicine. These sessions take place twice annually, emphasizing the structured nature of the support group. Weekly themes include self-care, adaptation, coping skills, emotions, anticipatory grief, forgiveness, mindfulness, boundaries, and closure. Care partners actively participate by sharing experiences and asking questions in each session. | Behavioural | Care partners of patients with advanced Parkinsonian Syndromes |
Primary outcome
Changes in Care Partner Burden: Assessed using ZBI-12.
Time frame: Enrollment and at the end of the Support Group. 1 and 16 weeks.
ZBI-12 is validated as a screening tool for advanced illness. The ZBI-12 is rated on a 12 items scale, with the severity of burden using a range of responses from 0 to 4 points per item and a total score range of 0 to 48. Scoring 0-10 is considered as a no to mild burden; 10-20, a mild to moderate burden and >20, a high burden. It measures changes in physical, emotional, social, and financial problems that can be experienced by family caregivers.
Changes in Coping Strategies: Evaluated with Brief-COPE scale.
Time frame: Enrollment and at the end of the Support Group. 1 and 16 weeks.
The Brief COPE (Coping Orientation to Problems Experienced) scale, composed of 28 items, each rated on a 4-point scale where 3 represents the highest score, exhibits a minimum value of 0 and a maximum value of 84. When interpreting Brief COPE scores, higher values are indicative of a potentially enhanced capacity to navigate stress and handle challenging situations. These elevated scores reflect a greater propensity to employ diverse coping strategies when confronted with difficulties.
Changes in Quality of Life: Scrutinized using AC-QoL scale.
Time frame: Enrollment and at the end of the Support Group. 1 and 16 weeks.
The Adult Carer Quality of Life (AC-QoL) Scale encompasses both an overall scale and eight subscales. The overall scale yields scores ranging from 0 to 120, with higher scores signifying an enhanced quality of life for caregivers. Additionally, each of the eight subscales offers scores within a potential range of 0 to 15. Higher scores on these subscales indicate an improved quality of life for caregivers in specific domains pertaining to their caregiving responsibilities. This structured assessment provides valuable insights into the well-being of caregivers across multiple dimensions of their lives.
1 secondary outcome
Satisfaction with Participation: Caregiver Support Group Satisfaction Survey
Time frame: Byweekly for 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Parkinson's Disease and Parkinsonism
Recruiting
Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
Parkinson's Disease (PD)
Not yet recruiting
Cognitive-Motor Training for Gait Adaptability in Parkinson Disease
Parkinson Disease
RecruitingPhase 2
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Parkinson Disease, Parkinson
Recruiting
Strength and Dual-Task on Sarcopenia in People With Parkinson's Disease
PARKINSON DISEASE (Disorder), Parkinsonism or Parkinson's Disease Nos
Recruiting
Dual Tasking Training to Enhance Self-Efficacy in Individuals With Parkinson's Disease
Parkinson´s Disease
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.
Veronica Bruno, MD, MPH principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Support Group in people with Parkinson's Disease and Parkinsonism, run by University of Calgary at 1 site in Canada.
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 2 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: status not confirmed, as of the sponsor's last update on 12 Oct 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 Canada. 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 Veronica Bruno, MD, MPH (4032107542, veronica.bruno@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Care Partner Burden: Assessed using ZBI-12. (time frame: Enrollment and at the end of the Support Group. 1 and 16 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?
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 12 Oct 2023.