Effects of the WHO 8-step Wheelchair Service Delivery Process on Wheelchair Users in El Salvador: a Cohort Study

NCT ID: NCT04936087

Last Updated: 2021-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-08
• Study Completion Date: 2019-11-25

Brief Summary

The objective of this study was to test the hypotheses that wheelchair-related health, wheelchair skills, wheelchair use, poverty probability, and quality of life would improve; and that the number of wheelchair repairs required, adverse events, caregiver burden and the level of assistance provided would decrease after the delivery of manual wheelchairs following the World Health Organization (WHO) 8-step service-delivery process.

This was a longitudinal, within-subject study design including 247 manual wheelchair users in El Salvador. The intervention consisted of the WHO 8-step process as well as maintenance reminders. Outcome assessments on wheelchair-related health, wheelchair skills, wheelchair repairs required, adverse events, caregiver burden and the level of assistance, poverty probability, and quality of life were performed via structured interviews at the initial assessment, at wheelchair delivery, and at 3- and 6-month follow-up. Wheelchair use was measured with dataloggers at assessment, delivery and 3-month follow-up.

Detailed Description

Ethics approval was granted from the National Committee on Research Ethics for Health in El Salvador (CNEIS/2018/043) and the Institutional Review Board at the University of Pittsburgh (number PRO18010578). Written informed consent was obtained from all participants before implementing study procedures.

All procedures of the study were conducted at 11 different rehabilitation centers, that served as wheelchair service delivery centers, in El Salvador.

A consecutive sampling method was used to select participants using the waitlists at the 11 rehabilitation centers. The investigators recruited wheelchair users and their caregivers.

Following the initial assessment, all participants were placed on a waiting list until wheelchairs and services were available. All study participants were provided with a new wheelchair (standard, active, or all-terrain model), a wheelchair cushion, and wheelchair services, delivered by trained wheelchair service providers, according to the WHO 8-step wheelchair service delivery process including assessment, fitting, and a 30-minute individual or group training on 7 wheelchair skills, device care, and pressure injury prevention techniques.

In addition, all wheelchairs were provided with a basic contour cushion made of polyurethane foam. However, whenever a risk of pressure injury was identified for a study participant, wheelchair providers fabricated a pressure-relief cushion based on the WHO basic wheelchair service guidelines.

Data were collected between January and November 2019, by a group of eight data collectors from the University of El Salvador.

Study participants were interviewed during the wheelchair assessment (about 2 months before wheelchair delivery), at the wheelchair delivery visit, and at 3- and 6-month follow-up visits after wheelchair delivery. Participants who were not able to attend a follow-up visit were interviewed by phone. Data were collected using the following questionnaires and tools translated into Spanish which included demographic, clinical and wheelchair-related questions, wheelchair skills, maintenance patterns, poverty probability, quality of life, and all their health related questions. Data loggers (DLs) were also used to assess number of days of wheelchair use, daily distance traveled, and speed. Caregivers were interviewed to measure caregiver burden at baseline, at 3-month follow-up, and at 6-month follow-up.

Conditions

Wheelchair Users

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

WHO 8-steps

Single group intervention and described in the Intervention section.

Group Type: OTHER

The World Health Organization 8 steps for manual wheelchair service delivery

Intervention Type: OTHER

All study participants were provided with a new wheelchair, a wheelchair cushion, and wheelchair services, delivered by trained wheelchair service providers, according to the WHO 8-step wheelchair service delivery process including assessment, fitting, and a 30-minute individual or group training on 7 wheelchair skills, device care, and pressure injury prevention techniques. Additionally, wheelchair maintenance reminders were sent through a text message service (SMS) to a sub-cohort of participants.

Wheelchair users were provided with one of three different, International Standards Organization (ISO) tested, wheelchair models according to the users' needs and availability: standard, active, and all-terrain models. All wheelchairs were provided with a basic contour cushion made of polyurethane foam. However, whenever a risk of pressure injury was identified for a study participant, wheelchair providers fabricated a pressure-relief cushion.

Interventions

The World Health Organization 8 steps for manual wheelchair service delivery

All study participants were provided with a new wheelchair, a wheelchair cushion, and wheelchair services, delivered by trained wheelchair service providers, according to the WHO 8-step wheelchair service delivery process including assessment, fitting, and a 30-minute individual or group training on 7 wheelchair skills, device care, and pressure injury prevention techniques. Additionally, wheelchair maintenance reminders were sent through a text message service (SMS) to a sub-cohort of participants.

Wheelchair users were provided with one of three different, International Standards Organization (ISO) tested, wheelchair models according to the users' needs and availability: standard, active, and all-terrain models. All wheelchairs were provided with a basic contour cushion made of polyurethane foam. However, whenever a risk of pressure injury was identified for a study participant, wheelchair providers fabricated a pressure-relief cushion.

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

• Wheelchair users who required postural support to sit upright were excluded.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Universidad de El Salvador

OTHER

Sponsor Role: collaborator

Google LLC.

INDUSTRY

Sponsor Role: collaborator

Momentum Wheels for Humanity

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jon Pearlman

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Foundation Pro Rehabilitation Teleton- FUNTER Merliot

Antiguo Cuscatlán, , El Salvador

Medical Unit Ilopango -ISSS

Ilopango, , El Salvador

Polyclinic Hospital Planes de Renderos -ISSS

Planes de Renderos, , El Salvador

Regional Hospital San Miguel -ISSS

San Miguel, , El Salvador

Medical Unit 15 de Septiembre -ISSS

San Salvador, , El Salvador

Physical Medicine and Rehabilitation Unit- ISSS

San Salvador, , El Salvador

Foundation Pro Rehabilitation Teleton- FUNTER San Vicente

San Vicente, , El Salvador

Santa Ana's Hospital -ISSS

Santa Ana, , El Salvador

El Salvador's UCP Wheels for Humanity

Santa Tecla, , El Salvador

Foundation Pro Rehabilitation Teleton- FUNTER Sonsonate

Sonsonate, , El Salvador

Sonsonate's Regional Hospital -ISSS

Sonsonate, , El Salvador

Usulutan's Hospital -ISSS

Usulután, , El Salvador

Polyclinic Hospital Zacamil -ISSS

Zacamil, , El Salvador

Countries

El Salvador

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CNEIS/2018/043

Identifier Type: OTHER

Identifier Source: secondary_id

PRO18010578

Identifier Type: -

Identifier Source: org_study_id