Dysphagia Management for Caregivers of Stroke Patients

NCT07181629 | Completed

• 1 other identifier: H.Yıldız1
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled experimental study was conducted to evaluate the effects of dysphagia management training provided to caregivers of stroke patients receiving home care. The sample size was determined using power analysis (n=84). Data were collected using the Personal Information Form, Mini Nutritional Assessment-Short Form (MNA-SF), Zarit Caregiver Burden Scale, Short Form-36 (SF-36) Quality of Life Questionnaire, and the Dysphagia Management Knowledge Form for Stroke Patients. Questionnaires were administered to both groups at baseline, the 1st month, and the 3rd month. The first application was administered to the intervention group before the education session.

Conditions

Stroke ( 3 Months After Onset); Dysphagia; Palliative Care; Caregiver

Keywords

Stroke, dysphagia, caregiver, malnutrition, quality of life, caregiver burden

Outcome Measures

Primary Outcomes (4)

• Care burden level

  The Zarit Care Burden Scale consists of 22 statements. As the score increases, the care burden also increases, and the maximum score is 88. Scores are graded as follows: (0-20) little/no burden, (21-40) moderate burden, (41-60) severe burden, and (61-88) excessive burden.

  0th month (1st day), 1st month and 3rd month

• Quality of Life level

  SF-36 Quality of Life Scale: The scale consists of 36 questions and eight subscales. Each subscale is scored separately from 0 to 100. Higher scores indicate better health.

  0th month (1st day), 1st month and 3rd month

• Nutritional Assessment level

  The MNA form consists of six questions. The maximum total score is 14. Individuals with a score of 12 or higher are considered to have adequate nutritional status, those with a score between 8 and 11 are at risk for malnutrition, and those with a score of 7 or less are considered malnourished.

  0th month (1st day), 1st month and 3rd month

• Dysphagia management knowledge level

  The Dysphagia Management Knowledge Form for Stroke Patients Form for Stroke Patients consists of 26 statements, each answered with a true (0 point) or false (1 point) score. Scale scores range from 0 to 26. Higher scores indicate higher knowledge levels.

  0th month (1st day), 1st month and 3rd month

Study Arms (2)

Intervention

EXPERIMENTAL

Dysphagia Management Education

Behavioral: Dysphagia Management Education

Control

OTHER

Other: Control

Interventions

Control OTHER

The Personal Information Form, Mini Nutritional Assessment-Short Form (MNA-SF), Zarit Caregiver Burden Scale, Short Form-36 (SF-36) Quality of Life Questionnaire, and the Dysphagia Management Knowledge Form for Stroke Patients administered to caregivers of stroke patients at each interview (at 0, 1, and 3 months).

Control

Dysphagia Management Education BEHAVIORAL

The Personal Information Form, Mini Nutritional Assessment-Short Form (MNA-SF), Zarit Caregiver Burden Scale, Short Form-36 (SF-36) Quality of Life Questionnaire, and the Dysphagia Management Knowledge Form for Stroke Patients administered to caregivers of stroke patients at each interview (at 0, 1, and 3 months). The intervention group received dysphagia management training after the questionnaires were administered at the first meeting.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregivers:
• The caregiver must be between 18 and 60 years old. The caregiver must be willing and able to participate in the study. The caregiver must have at least a primary school education. The caregiver must be primarily responsible for the patient's care. The caregiver's Mini Mental Test score must be 25 or more. The caregiver's Beck Depression Inventory score must be below 17. The caregiver's Caregiver's Readiness to Care Scale score must be 16 or more.
• Patients:
• The patient's National Institutes of Health (NIH) Stroke Scale score must be 20 or less.
• The patient must be between 18 and 60 years old. The patient must be receiving home care services. The patient must have been diagnosed with a stroke at least six months ago. The patient must have a Barthel index score of 90 or below.

You may not qualify if:

• Caregivers:
• The caregiver has a physical disability or serious health problem that makes caregiving difficult.
• The caregiver has a Mini Mental Test score below 25 points. The caregiver has a Beck Depression Inventory score of 17 or higher. The caregiver has a Caregiver Readiness Scale score of 16 or lower. The caregiver has communication difficulties. The caregiver has a depression or psychiatric diagnosis. The caregiver is receiving psychotherapy/psychological support. The caregiver is taking antidepressants and/or anxiolytics. The caregiver has sensory loss related to vision or hearing.
• Patients:
• The patient has a Barthel index score of 91 or higher. The patient is receiving parenteral nutrition. The patient is receiving immunosuppressive therapy/immunotherapy and/or chemotherapy.
• The patient has been diagnosed with cancer, an endocrine system disease, or a gastrointestinal disease.

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Simav Assoc. Prof. Dr. İsmail Karakuyu State Hospital Home Health Services Unit

Kütahya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Deglutition Disorders; Malnutrition; Caregiver Burden

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 18, 2025
• Study Start: December 15, 2021
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

TU (1)