Clinical trial NCT04936087: Effects of the WHO 8-step Wheelchair Service Delivery Process on Wheelchair Users in El Salvador: a Cohort Study
Official title: Wheelchair User's Voice- A Longitudinal Study About the Impact of the WHO-8 Steps for Wheelchair Provision in El Salvador
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wheelchair Users
Keywords: manual wheelchairs
appropriate service delivery
low- and middle-income countries
global health
Lead sponsor: Momentum Wheels for Humanity
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: Universidad de El Salvador
name: Google LLC.
First posted: 2021-06-23
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal within-subject design
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for wheelchair users were being a person with a mobility limitation requiring a wheelchair as a primary means of personal mobility, waiting to receive a new wheelchair from any of the participating wheelchair service delivery centers, 18-years of age or older, had the cognitive and verbal abilities required to respond to the study questions or a proxy who could respond on his or her behalf, and had access to a cellphone.
* Inclusion criteria for caregivers were being a person assisting the wheelchair user with activities of daily living (ADL), 18-years of age or older, being the primary caregiver and willing to participate in the study.

Exclusion Criteria:

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

Primary outcomes:
measure: Massachusetts Institute of Technology (MIT)-Wheelchair-related Health Questionnaire
timeFrame: At month 0 (baseline assessment)
measure: Massachusetts Institute of Technology (MIT)-Wheelchair-related Health Questionnaire
timeFrame: At wheelchair delivery (approx. 2 months after baseline assessment)
measure: Massachusetts Institute of Technology (MIT)-Wheelchair-related Health Questionnaire
timeFrame: 3 months after wheelchair delivery
measure: Massachusetts Institute of Technology (MIT)-Wheelchair-related Health Questionnaire
timeFrame: 6 months after wheelchair delivery
measure: Wheelchair Skills Test Questionnaire
timeFrame: At month 0 (baseline assessment)
measure: Wheelchair Skills Test Questionnaire
timeFrame: 3 months after wheelchair delivery
measure: Wheelchair Skills Test Questionnaire
timeFrame: 6 months after wheelchair delivery
measure: Number of days of wheelchair use
timeFrame: At month 0 (baseline assessment)
measure: Daily distance traveled
timeFrame: At month 0 (baseline assessment)
measure: Average speed
timeFrame: At month 0 (baseline assessment)
measure: Number of days of wheelchair use
timeFrame: At wheelchair delivery (approx. 2 months after baseline assessment)
measure: Daily distance traveled
timeFrame: At wheelchair delivery (approx. 2 months after baseline assessment)
measure: Average speed
timeFrame: At wheelchair delivery (approx. 2 months after baseline assessment)
measure: Number of days of wheelchair use
timeFrame: 3 months after wheelchair delivery
measure: Daily distance traveled
timeFrame: 3 months after wheelchair delivery
measure: Average speed
timeFrame: 3 months after wheelchair delivery
measure: Poverty Probability Index for El Salvador
timeFrame: At month 0 (baseline assessment)
measure: Poverty Probability Index for El Salvador
timeFrame: 6 months after wheelchair delivery
measure: WHO Quality of Life Questionnaire - Brief version
timeFrame: At month 0 (baseline assessment)
measure: WHO Quality of Life Questionnaire - Brief version
timeFrame: 6 months after wheelchair delivery
Secondary outcomes:
measure: Wheelchair Maintenance Training Questionnaire
timeFrame: At month 0 (baseline assessment)
measure: Wheelchair Maintenance Training Questionnaire
timeFrame: 3 months after wheelchair delivery
measure: Wheelchair Maintenance Training Questionnaire
timeFrame: 6 months after wheelchair delivery
measure: Zarit Burden Interview - short version
timeFrame: At month 0 (baseline assessment)
measure: Zarit Burden Interview - short version
timeFrame: 3 months after wheelchair delivery
measure: Zarit Burden Interview - short version
timeFrame: 6 months after wheelchair delivery
measure: Checklist of Activities of Daily Living
timeFrame: At month 0 (baseline assessment)
measure: Checklist of Activities of Daily Living
timeFrame: 3 months after wheelchair delivery
measure: Checklist of Activities of Daily Living
timeFrame: 6 months after wheelchair delivery
measure: Breakdowns and Adverse Consequences Questionnaire
timeFrame: At month 0 (baseline assessment)
measure: Breakdowns and Adverse Consequences Questionnaire
timeFrame: At wheelchair delivery (approx. 2 months after baseline assessment)
measure: Breakdowns and Adverse Consequences Questionnaire
timeFrame: 3 months after wheelchair delivery
measure: Breakdowns and Adverse Consequences Questionnaire
timeFrame: 6 months after wheelchair delivery
Other outcomes:
Locations:
city: Antiguo Cuscatlán
country: El Salvador
facility: Foundation Pro Rehabilitation Teleton- FUNTER Merliot
city: Ilopango
country: El Salvador
facility: Medical Unit Ilopango -ISSS
city: Planes de Renderos
country: El Salvador
facility: Polyclinic Hospital Planes de Renderos -ISSS
city: San Miguel
country: El Salvador
facility: Regional Hospital San Miguel -ISSS
city: San Salvador
country: El Salvador
facility: Medical Unit 15 de Septiembre -ISSS
city: San Salvador
country: El Salvador
facility: Physical Medicine and Rehabilitation Unit- ISSS
city: San Vicente
country: El Salvador
facility: Foundation Pro Rehabilitation Teleton- FUNTER San Vicente
city: Santa Ana
country: El Salvador
facility: Santa Ana's Hospital -ISSS
city: Santa Tecla
country: El Salvador
facility: El Salvador's UCP Wheels for Humanity
city: Sonsonate
country: El Salvador
facility: Foundation Pro Rehabilitation Teleton- FUNTER Sonsonate
city: Sonsonate
country: El Salvador
facility: Sonsonate's Regional Hospital -ISSS
city: Usulutan
country: El Salvador
facility: Usulutan's Hospital -ISSS
city: Zacamil
country: El Salvador
facility: Polyclinic Hospital Zacamil -ISSS
Study officials:
affiliation: University of Pittsburgh
name: Jon Pearlman
role: PRINCIPAL_INVESTIGATOR
References: