NCT07876830

Brief Summary

The aim of this study is to evaluate the effect of artificial intelligence-supported training and the Benson relaxation exercise on the care burden and stress levels of caregivers of people with Parkinson's disease. In the study, caregivers of people with Parkinson's disease will receive training on caring for people with Parkinson's disease and on the Benson relaxation exercise. The training sessions will be conducted using an artificial intelligence-based module. Participants will be randomly assigned to three groups: a training group, an exercise group, and a control group. A caregiver information form, the Modified Hoehn and Yahr Scale, the Zarit Caregiver Burden Scale, and the Caregiver Stress Scale will be used to collect pretest data from all participants during the initial interview. The training sessions for the experimental group will last 4 weeks. No training will be provided to the control group. Four weeks later, the Zarit Caregiver Burden Scale and the Caregiver Stress Scale will be used to collect final test data from the experimental and control groups. The hypotheses related to this study are as follows:

  • Artificial intelligence-supported training provided to caregivers of people with Parkinson's disease affects the burden of care.
  • The Benson relaxation exercise provided to caregivers of people with Parkinson's disease affects the burden of care.
  • Artificial intelligence-supported training provided to caregivers of people with Parkinson's disease affects stress levels.
  • The Benson relaxation exercise administered to caregivers of people with Parkinson's disease affects stress levels.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Nov 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

October 15, 2026

Status Verified

October 1, 2026

Enrollment Period

7 months

First QC Date

October 9, 2026

Last Update Submit

October 9, 2026

Conditions

Keywords

Parkinson's disease; caregivers; burden; stressBenson exercises; Trainingartificial intelligent

Outcome Measures

Primary Outcomes (2)

  • Zarit Caregiver Burden Scale

    This is a measure used to assess the stress experienced by caregivers of individuals requiring care or the elderly. The measurement tool consists of 22 items. The items are Likert-type, and each item is rated on a scale of 0 to 4, using the response options "never," "rarely," "sometimes," "often," or "almost always." A score ranging from 0 to 88 is possible on this scale. A high scale score indicates a high level of distress.

    The scale will be completed at the start of the study and 4 weeks after the completion of training and exercise.

  • Caregiver Stress Scale

    It was developed to measure the caregiving burden. It consists of 13 items. There is at least one item for each category: physical, social, work, financial, and time. On the scale, a score of 7 or higher indicates a higher level of stress.

    The scale will be completed at the start of the study and 4 weeks after the completion of training and exercise.

Study Arms (3)

training group

EXPERIMENTAL

Artificial intelligent-based training

Behavioral: artificial intelligent-based training

exercises group

EXPERIMENTAL

Artificial intelligent-based Benson's relaxation exercises

Behavioral: artificial intelligent-based Benson's relaxation exercise

control group

NO INTERVENTION

usual care

Interventions

experimental group

training group

experimental group

exercises group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be 18 years of age or older
  • Be a family member of the patient (spouse, daughter, son, etc.)
  • Living in the same household as the patient
  • Having cared for the patient for at least 6 months
  • Being the primary caregiver responsible for the patient's care
  • There being no paid staff member in the home to assist the caregiver
  • Having no health issues that prevent communication
  • Being able to read and write
  • Having access to a phone for communication

You may not qualify if:

  • Having visual, auditory, or cognitive communication barriers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

FATMA NUR KIRKINCI, REGISTRY NURSE

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD STUDENT/RN

Study Record Dates

First Submitted

October 9, 2026

First Posted

October 15, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

October 15, 2026

Record last verified: 2026-10