NCT07099326

Brief Summary

The goal of this clinical trial is to find out if educational videos-especially interactive ones-can help people on dialysis better manage their treatment. Researchers want to answer the following main questions: Can interactive or conventional video-based education help patients better understand and follow their treatment plan? Does this type of education improve patients' ability to control their weight changes between dialysis sessions? Does this type of education improve patients' activation? Is interactive video education more effective than regular (non-interactive) video education? What Will Happen in the Study: Adults on hemodialysis will take part in the study. They will be randomly assigned to one of three groups: Group A: Will receive 10 interactive educational video sessions (30 minutes each). Group B: Will receive the same videos but in a non-interactive format. Group C (Control Group): Will receive routine education normally given at the dialysis center. Videos will be watched on a web platform. Interactive videos include pop-up questions and scenario-based feedback. All participants will be followed up immediately, 1 month, and 3 months after the program ends. What Participants Will Do: Watch educational videos over several days (totaling 5 hours). Answer questions and engage in follow-up group discussions. Complete surveys about their knowledge, treatment adherence, and health behaviors. Get weighed before and after dialysis sessions to monitor fluid retention. This study aims to improve how dialysis patients manage their condition and to help healthcare providers design better educational tools.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

August 5, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2025

Completed
Last Updated

August 5, 2025

Status Verified

July 1, 2025

Enrollment Period

1 month

First QC Date

July 25, 2025

Last Update Submit

July 31, 2025

Conditions

Keywords

Interactive Video-Based EducationConventional Video-Based EducationPatient ActivationPatient Treatment AdherencePatients' Weight ChangesDialysis

Outcome Measures

Primary Outcomes (1)

  • Patients Activation Measure

    Patient activation refers to an individual's knowledge, skills, confidence, and willingness to manage their own health and healthcare. In this study, patient activation is considered a primary behavioral outcome, as the educational intervention is designed to empower participants to take a more active role in managing their dialysis treatment and overall health. The Patient Activation Measure (PAM), developed by Hibbard and colleagues, consists of 13 items and is a valid and reliable tool for assessing patient activation in the field of nephrology. Responses are recorded using a five-point Likert scale ("Strongly disagree" = 1, "Disagree" = 2, "Agree" = 3, "Strongly agree" = 4, and "Not applicable" = no score). The raw total scores range from 13 to 52, with lower scores indicating lower activation levels and higher scores indicating higher activation levels (41).

    Baseline (prior to the intervention) Immediately after the completion of the intervention One month post-intervention Three months post-intervention

Secondary Outcomes (2)

  • Treatment Adherence

    Baseline (prior to the intervention) Immediately after the completion of the intervention One month post-intervention Three months post-intervention

  • Patient Weight Changes

    Baseline (prior to the intervention) Immediately after the completion of the intervention One month post-intervention Three months post-intervention

Study Arms (3)

Interactive Video-Based Intervention

EXPERIMENTAL

Participants in this arm will undergo a two-phase educational intervention with a total duration of six hours. In the first phase, patients will access an interactive video series on end-stage renal disease (ESRD) and its treatment options via an online platform. The series consists of ten 30-minute sessions delivered daily. The videos include interactive elements such as pop-up questions and multiple-choice assessments, with responses monitored by an instructor. All participants will receive prior training on how to use the system. In the second phase, patients will attend a one-hour instructor-led group discussion to review and consolidate key concepts.

Other: Educational Method Using Interactive Video

Conventional Video-Based Education

EXPERIMENTAL

Participants in this arm will receive a two-phase educational intervention lasting a total of six hours. In the first phase, patients will access a series of conventional (non-interactive) educational videos on end-stage renal disease (ESRD) and treatment options via an online platform. The series consists of ten 30-minute sessions delivered daily. In the second phase, patients will participate in a one-hour instructor-led group discussion to review the video content, explore key concepts, and consolidate their understanding. Discussions will be facilitated by an experienced instructor familiar with the video content.

Other: Educational Method Using Conventional Video

Control Group (Usual Care)

NO INTERVENTION

Participants in this group will receive the standard educational care provided at their respective centers. This typically includes nurse-delivered patient education, distribution of educational pamphlets, and follow-up by the unit's assigned nurse educator.

Interventions

Phase 1 - Interactive Video-Based Training (10 sessions of 30 minutes each): Patients will access the platform via the website https://spotplayer.ir/ and watch a comprehensive interactive video related to end-stage renal disease (ESRD) and its replacement therapies. This video consists of ten 30-minute sessions, uploaded at the rate of one session per day. During the viewing, pop-up questions will appear, which patients are required to answer. Different response options will lead to the presentation of different educational scenarios. In addition, multiple-choice questions related to the content will be included throughout the video, and patients must record their answers in the system. The instructor will be able to review these responses through a management dashboard. It is worth noting that all patients will have previously received the necessary training to use the interactive videos, including Q\&A sessions designed to ensure sufficient skill acquisition in utilizing the interact

Interactive Video-Based Intervention

This educational intervention will be carried out in two phases with a total duration of six hours. A total of 55 patients will participate in this study, organized into groups of five and guided by an experienced instructor familiar with the interactive video-based educational system. Phase 1 - Conventional Video-Based Training (10 sessions of 30 minutes each): Patients will access the platform through the website https://spotplayer.ir/ and watch in-depth educational videos related to end-stage renal disease (ESRD) and its replacement therapies. The video content consists of ten 30-minute sessions, which will be uploaded for the patients at the rate of one session per day. Phase 2 - Consolidation and Reinforcement Session (1 hour): After completing the ten video sessions, patients will participate in group discussions to analyze the scenarios, topics, and questions presented in the videos. The instructor will facilitate the discussions, summarize the outcomes, and assess the over

Conventional Video-Based Education

Eligibility Criteria

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

You may qualify if:

  • Willingness to participate in the study;
  • Literate (ability to read and write);
  • Alertness and orientation to time, place, and person sufficient to respond to questions;
  • No history of hearing or visual impairments;
  • No cognitive disorders;
  • Possession of a personal mobile phone or any other device capable of running interactive videos, and the ability to use it;
  • No use of psychoactive medications;
  • Confirmed diagnosis of chronic kidney disease by a nephrology specialist and having a medical record in the dialysis unit;
  • Age between 18 and 65 years.

You may not qualify if:

  • Withdrawal from the study at any stage;
  • Failure to receive and watch the provided videos;
  • Patient death;
  • Transfer to a healthcare center outside the coverage of Shahid Beheshti University of Medical Sciences.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sarmadi S, Sanaie N, Zare-Kaseb A. Comparing the effects of interactive and conventional video education on activation, treatment adherence, and weight changes in dialysis patients: A randomized clinical trial protocol. PLoS One. 2025 Oct 15;20(10):e0334498. doi: 10.1371/journal.pone.0334498. eCollection 2025.

MeSH Terms

Conditions

Patient ParticipationBody Weight ChangesTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareHealth BehaviorBehaviorBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 25, 2025

First Posted

August 1, 2025

Study Start

August 5, 2025

Primary Completion

September 5, 2025

Study Completion

October 5, 2025

Last Updated

August 5, 2025

Record last verified: 2025-07