Caregiving in Advanced PD: A Tailored Support Group

NCT06074393 | Unknown DMC

• 1 other identifier: REB23-0949
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Parkinson's Disease and Parkinsonism

Keywords

Support group; Care partners

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Enrollment and at the end of the Support Group. 1 and 16 weeks.

Secondary Outcomes (1)

• Satisfaction with Participation: Caregiver Support Group Satisfaction Survey

  Byweekly for 16 weeks

Study Arms (1)

Care partners of patients with advanced Parkinsonian Syndromes

EXPERIMENTAL

Care partners of patients with advanced Parkinsonian Syndromes will participate in a tailored support group

Behavioral: Tailored Support Group

Interventions

Tailored Support Group BEHAVIORAL

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.

Also known as: Support Group

Care partners of patients with advanced Parkinsonian Syndromes

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Health Science Centre, University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Veronica Bruno, MD, MPH

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica Bruno, MD, MPH

CONTACT

4032107542; veronica.bruno@ucalgary.ca

Karla Cantu Flores

CONTACT

4032107542; karla.cantuflores1@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor. Department of Clinical Neurosciences

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 10, 2023
• Study Start: October 19, 2023
• Primary Completion: October 19, 2024
• Study Completion: October 31, 2024
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)