ClinicalTrials.gg
Not yet recruitingNCT07099326Updated Aug 5, 2025

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

An interventional study of Educational Method Using Interactive Video and Educational Method Using Conventional Video in Hemodialysis, Nurse and Educational Videos, sponsored by Shahid Beheshti University of Medical Sciences. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-05.

Primary conditionPatient Participation(the registry's first term)UnverifiedIs this wrong?Patient Participation is a broad heading, used only when no more specific condition is named. No better condition is named, so the registry's term is kept.

Sponsored by Shahid Beheshti University of Medical Sciences · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hemodialysis
  • Nurse
  • Educational Videos
  • Patient Activation
  • Weight Change
  • Treatment Adherence

Keywords

  • Interactive Video-Based Education
  • Conventional Video-Based Education
  • Patient Activation
  • Patient Treatment Adherence
  • Patients' Weight Changes
  • Dialysis
03

In context

Patient Participation Unverified

409 studies on the registry are indexed under Patient Participation; 101 are open to participants now.

This study's planned enrollment of 165 is above the median of 128 across 322 interventional studies indexed under Patient Participation.

Browse Patient Participation studies →

Lead sponsor

Shahid Beheshti University of Medical Sciences is the lead sponsor of 229 studies on the registry; 19 are open to participants now.

Compared within Patient Participation, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Withdrawal from the study at any stage;
  2. Failure to receive and watch the provided videos;
  3. Patient death;
  4. Transfer to a healthcare center outside the coverage of Shahid Beheshti University of Medical Sciences.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
165 participants (estimated)

Study arms

  • Experimental
    Interactive Video-Based Intervention

    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

  • Experimental
    Conventional Video-Based Education

    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

  • No intervention
    Control Group (Usual Care)

    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

  • OtherEducational Method Using Interactive Video

    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

  • OtherEducational Method Using Conventional Video

    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

06

What researchers measure

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).

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

Secondary outcomes

  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

    Time frame: 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.

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

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2025; primary completion for Sep 2025, 1 month later.

Of 219 non-industry interventional studies with no phase under Patient Participation, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's planned 1 month is below that.

Counting every sponsor, half of 226 studies reached it within 20 months; a quarter within 10 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 25, 2025
First posted
Aug 1, 2025
StartEst.
Aug 5, 2025
Primary completionEst.
Sep 5, 2025
CompletionEst.
Oct 5, 2025
Last update
Aug 5, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07099326
Responsible party
Sogand Sarmadi (Principal Investigator, Shahid Beheshti University of Medical Sciences) — Principal investigator
First posted
Aug 1, 2025
Start date
Aug 5, 2025 (estimated)
Primary completion
Sep 5, 2025 (estimated)
Completion
Oct 5, 2025 (estimated)
Last update
Aug 5, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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