NCT04966286

Brief Summary

This report was an effective evaluation of using multimedia educational program for self-care and quality of life in patients with a stoma at postoperative and established a simple threshold for enterostomy self-care skills.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
Last Updated

July 19, 2021

Status Verified

June 1, 2021

Enrollment Period

10 months

First QC Date

June 28, 2021

Last Update Submit

July 7, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • self-care ability

    Assessment scale of self-care ability of enterostomy care was a quantitative scale for nursing staff to evaluate self-care skills in patients with enterostomy. It consisted of 7 items related to: Prepare items, removing the pouching system, measuring the enterostomy diameter, adjusting the size of the enterostomy diameter in a new stoma appliance, skin care, fitting a new enterostomy appliance, and emptying procedure. Each skill was rated on a 4-point scale: Likert scale (1: not at all, 2: some, 3: quite a lot, 4: very much). Higher scores indicated that patient had a higher level of self-care skills for changing enterostomy pouching system

    One and a half years

Secondary Outcomes (1)

  • Promote quality of life

    One and a half years

Study Arms (2)

conventional education service program

PLACEBO COMPARATOR

received only standard enterostomy care brochure

Other: multimedia education

multimedia education service program

EXPERIMENTAL

received multimedia education service program introduction

Other: multimedia education

Interventions

The MLEP intervention was based on a literature review of prior research on the content and format of self care related multimedia education programmes

conventional education service programmultimedia education service program

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≧ 20
  • Operation with ostomy

You may not qualify if:

  • Dementia, mental illness, and central nervous system diseases
  • Unable self-care
  • Visual or hearing impairs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hsing Fang Ko

Kaohsiung City, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 19, 2021

Study Start

June 1, 2018

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

July 19, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations