AzTrials
AzTrials

HemodialysisNCT07099326

Interactive vs. Standard Video Education for Improving Outcomes in Hemodialysis Patients

A study testing Educational Method Using Interactive Video and Educational Method Using Conventional Video in people with Hemodialysis and Nurse, run by Shahid Beheshti University of Medical Sciences.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hemodialysis, Nurse, Educational Videos
What is being tested?
Educational Method Using Interactive Video and Educational Method Using Conventional Video
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
No sites listed yet
Study dates
5 Aug 2025to 5 Oct 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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.

About this study

Official title: Examining the Effects of Interactive Versus Conventional Video-Based Education on Activation, Treatment Adherence, and Weight Changes in Dialysis Patients: A Randomized Clinical Trial Protocol

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:

Read more

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.

Being tested
Educational Method Using Interactive Video, Educational Method Using Conventional Video
Keywords
Interactive Video-Based Education, Conventional Video-Based Education, Patient Activation, Patient Treatment Adherence, Patients' Weight Changes, Dialysis
Medical subject headings
Patient Participation, Body Weight Changes, Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational Method Using Interactive VideoOther

    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

  • Educational Method Using Conventional VideoOther

    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

Study groups in NCT07099326
Study groupRoleWhat they receive
Interactive Video-Based InterventionExperimentalParticipants 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.
Receives: Other: Educational Method Using Interactive Video
Conventional Video-Based EducationExperimentalParticipants 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.
Receives: Other: Educational Method Using Conventional Video
Control Group (Usual Care)No interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (2)

  1. Treatment Adherence

    The End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ) is a self-report instrument consisting of 46 items across five domains, designed to assess patient adherence to treatment in four areas: attendance at hemodialysis sessions, medication adherence, fluid restrictions, and dietary recommendations. The first section of the questionnaire collects general information about patients' knowledge of ESRD and their history of renal replacement therapy (5 items). The subsequent four sections assess adherence to hemodialysis attendance (14 items), medication use (9 items), fluid restriction (10 items), and dietary recommendations (8 items), respectively. Responses are recorded using a combination of Likert scales, multiple-choice questions, and yes/no formats. The total score ranges from 0 to 1200, with higher scores indicating greater adherence to treatment (43). The reliability of this instrument was confirmed by Rafiei et al. (2014), with a Cronbach's alpha of 0.91 and a test-retest

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

  2. Patient Weight Changes

    In this study, interdialytic weight gain (IDWG) will be assessed by measuring patients' weight immediately before connection to the hemodialysis machine and immediately after the completion of each session, following a standardized protocol. All weight measurements will be conducted using a calibrated medical digital scale (calibrated monthly). Patients will consistently be weighed wearing a standardized light dialysis gown, after emptying their bladder and refraining from food or beverage intake. Additionally, all personal items (such as shoes, bags, and jewelry) will be removed prior to weighing. Trained staff or the researcher will carefully record all measurements at fixed time points (pre-dialysis and post-dialysis) to ensure data consistency and allow accurate comparison of weight changes throughout the treatment period.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2025
  2. Study start5 Aug 2025 (estimated)
  3. Primary completion5 Sep 2025 (estimated)
  4. Study completion5 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
165 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07099326
Sponsor's protocol ID
IR.SBMU.PHARMACY.REC.1404.067
Status last verified
Jul 2025
First submitted
25 Jul 2025
Last updated
5 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 41091721

Questions about this trial

What is this clinical trial studying?

A study testing Educational Method Using Interactive Video and Educational Method Using Conventional Video in people with Hemodialysis and Nurse, run by Shahid Beheshti University of Medical Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients Activation Measure (time frame: Baseline (prior to the intervention) Immediately after the completion of the intervention One month post-intervention Three months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07099326, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.

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