Caregiving in Advanced PD: A Tailored Support Group

October 10, 2023 updated by: Veronica Bruno, University of Calgary

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?

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Care partners of individuals with a confirmed diagnosis of Parkinsonian Syndrome.
  • Participants in the Calgary Movement Disorders Advanced Care pilot program (REB22-0545)

Exclusion Criteria:

  • Care partners with significant cognitive impairments that hinder participation with MoCA<10 points.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Care partners of patients with advanced Parkinsonian Syndromes
Care partners of patients with advanced Parkinsonian Syndromes will participate in a tailored support group
Behavioral: Tailored 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.
Other Names:
  • Support Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Enrollment and at the end of the Support Group. 1 and 16 weeks.
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.
Enrollment and at the end of the Support Group. 1 and 16 weeks.
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.
Enrollment and at the end of the Support Group. 1 and 16 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with Participation: Caregiver Support Group Satisfaction Survey
Time Frame: Byweekly for 16 weeks
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.
Byweekly for 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Veronica Bruno, MD, MPH, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 19, 2023

Primary Completion (Estimated)

October 19, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

September 28, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB23-0949

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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