Dysphagia Management for Caregivers of Stroke Patients

NCT ID: NCT07181629

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-15
• Study Completion Date: 2023-06-15

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.

Detailed Description

The experimental randomized controlled trial 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). Patients who met the inclusion criteria were assigned to the experimental (n=42) and control (n=42) groups using a simple randomization technique. Data were collected using the 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.In data evaluation, percentages, means, independent t-tests, Pearson chi-square tests, Yates chi-square tests, repeated measures variance analysis (ANOVA), Pearson correlation tests, and Bonferroni tests were used.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention

Dysphagia Management Education

Group Type: EXPERIMENTAL

Dysphagia Management Education

Intervention Type: 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.

Control

Group Type: OTHER

Control

Intervention Type: 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).

Interventions

Control

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).

Intervention Type: OTHER

Dysphagia Management Education

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uludag University

OTHER

Sponsor Role: lead

Responsible Party

Hicran Yıldız

Prof.Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Kütahya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

H.Yıldız1

Identifier Type: -

Identifier Source: org_study_id