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

NCT04936087 | Completed

• 2 other identifiers: PRO18010578CNEIS/2018/043
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 13

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.

Conditions

Wheelchair Users

Keywords

manual wheelchairs; appropriate service delivery; low- and middle-income countries; global health

Outcome Measures

Primary Outcomes (20)

• Massachusetts Institute of Technology (MIT)-Wheelchair-related Health Questionnaire

  This questionnaire consists of 25 questions developed to identify the reasons, consequences, and medical attention received for injuries related to the use of the wheelchair such as falls during transfers, falls during maneuvering, injuries to the shoulders, elbows, wrists, hands and back.

  At month 0 (baseline assessment)

• Massachusetts Institute of Technology (MIT)-Wheelchair-related Health Questionnaire

  This questionnaire consists of 25 questions developed to identify the reasons, consequences, and medical attention received for injuries related to the use of the wheelchair such as falls during transfers, falls during maneuvering, injuries to the shoulders, elbows, wrists, hands and back.

  At wheelchair delivery (approx. 2 months after baseline assessment)

• Massachusetts Institute of Technology (MIT)-Wheelchair-related Health Questionnaire

  This questionnaire consists of 25 questions developed to identify the reasons, consequences, and medical attention received for injuries related to the use of the wheelchair such as falls during transfers, falls during maneuvering, injuries to the shoulders, elbows, wrists, hands and back.

  3 months after wheelchair delivery

• Massachusetts Institute of Technology (MIT)-Wheelchair-related Health Questionnaire

  This questionnaire consists of 25 questions developed to identify the reasons, consequences, and medical attention received for injuries related to the use of the wheelchair such as falls during transfers, falls during maneuvering, injuries to the shoulders, elbows, wrists, hands and back.

  6 months after wheelchair delivery

• Wheelchair Skills Test Questionnaire

  The Wheelchair Skills Test Questionnaire, (WST-Q), allows assessing the capacity and frequency with which the wheelchair user performs a series of activities safely in their wheelchair. This instrument consists of 34 questions. Answer to the capacity component can be "no" "yes" "yes, with difficulty" and "not possible with this wheelchair". Possible answers to the frequency component are "always" "sometimes" or "never". Wheelchair Skills Capacity Score is reported in percentage, possible percentage scores range from 0-100%. 0% means the participants do not have the capacity to perform any of the wheelchair skills, and 100% means the participan has the capacity to perform all skills without difficulty.

  At month 0 (baseline assessment)

• Wheelchair Skills Test Questionnaire

  The Wheelchair Skills Test Questionnaire, (WST-Q), allows assessing the capacity and frequency with which the wheelchair user performs a series of activities safely in their wheelchair. This instrument consists of 34 questions. Answer to the capacity component can be "no" "yes" "yes, with difficulty" and "not possible with this wheelchair". Possible answers to the frequency component are "always" "sometimes" or "never". Wheelchair Skills Capacity Score is reported in percentage, possible percentage scores range from 0-100%. 0% means the participants do not have the capacity to perform any of the wheelchair skills, and 100% means the participan has the capacity to perform all skills without difficulty.

  3 months after wheelchair delivery

• Wheelchair Skills Test Questionnaire

  The Wheelchair Skills Test Questionnaire, (WST-Q), allows assessing the capacity and frequency with which the wheelchair user performs a series of activities safely in their wheelchair. This instrument consists of 34 questions. Answer to the capacity component can be "no" "yes" "yes, with difficulty" and "not possible with this wheelchair". Possible answers to the frequency component are "always" "sometimes" or "never". Wheelchair Skills Capacity Score is reported in percentage, possible percentage scores range from 0-100%. 0% means the participants do not have the capacity to perform any of the wheelchair skills, and 100% means the participan has the capacity to perform all skills without difficulty.

  6 months after wheelchair delivery

• Number of days of wheelchair use

  Number of days of wheelchair use

  At month 0 (baseline assessment)

• Daily distance traveled

  Measured in meters per day

  At month 0 (baseline assessment)

• Average speed

  Measured in meters per second

  At month 0 (baseline assessment)

• Number of days of wheelchair use

  Number of days of wheelchair use

  At wheelchair delivery (approx. 2 months after baseline assessment)

• Daily distance traveled

  Measured in meters per day

  At wheelchair delivery (approx. 2 months after baseline assessment)

• Average speed

  Measured in meters per second

  At wheelchair delivery (approx. 2 months after baseline assessment)

• Number of days of wheelchair use

  Number of days of wheelchair use

  3 months after wheelchair delivery

• Daily distance traveled

  Measured in meters per day

  3 months after wheelchair delivery

• Average speed

  Measured in meters per second

  3 months after wheelchair delivery

• Poverty Probability Index for El Salvador

  Poverty probability

  At month 0 (baseline assessment)

• Poverty Probability Index for El Salvador

  Poverty probability

  6 months after wheelchair delivery

• WHO Quality of Life Questionnaire - Brief version

  WHO Quality of Life Questionnaire - Brief version (WHOQOL-BREF) was developed to measure the quality of life of people. Its design is suitable to be used in different cultural environments with research objectives, policy making, health practices and auditing. WHOQOL-BREF is the reduced version of WHOQOL-100 and allows a complete evaluation when analyzing four fundamental domains, such as: physical, psychological, social relations and environment. It is designed in such a way that it can be answered by the participant with or without assistance. According to the information provided by the WHO, this tool has been shown to have good discriminating validity, content and reliability. The WHOQOL-BREF consists of 26 questions, but a question related to sexual activity was eliminated, because it was considered culturally inappropriate. The WHOQOL-BREF domains scores ranges from 4 to 20. A lower a score represents a worse outcome.

  At month 0 (baseline assessment)

• WHO Quality of Life Questionnaire - Brief version

  WHO Quality of Life Questionnaire - Brief version (WHOQOL-BREF) was developed to measure the quality of life of people. Its design is suitable to be used in different cultural environments with research objectives, policy making, health practices and auditing. WHOQOL-BREF is the reduced version of WHOQOL-100 and allows a complete evaluation when analyzing four fundamental domains, such as: physical, psychological, social relations and environment. It is designed in such a way that it can be answered by the participant with or without assistance. According to the information provided by the WHO, this tool has been shown to have good discriminating validity, content and reliability. The WHOQOL-BREF consists of 26 questions, but a question related to sexual activity was eliminated, because it was considered culturally inappropriate. The WHOQOL-BREF domains scores ranges from 4 to 20. A lower a score represents a worse outcome.

  6 months after wheelchair delivery

Secondary Outcomes (13)

• Wheelchair Maintenance Training Questionnaire

  At month 0 (baseline assessment)

• Wheelchair Maintenance Training Questionnaire

  3 months after wheelchair delivery

• Wheelchair Maintenance Training Questionnaire

  6 months after wheelchair delivery

• Zarit Burden Interview - short version

  At month 0 (baseline assessment)

• Zarit Burden Interview - short version

  3 months after wheelchair delivery

Study Arms (1)

WHO 8-steps

OTHER

Single group intervention and described in the Intervention section.

Other: The World Health Organization 8 steps for manual wheelchair service delivery

Interventions

The World Health Organization 8 steps for manual wheelchair service delivery 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.

WHO 8-steps

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Momentum Wheels for Humanity: lead
• University of Pittsburgh: collaborator
• Universidad de El Salvador: collaborator
• Google LLC.: collaborator

Study Sites (13)

Foundation Pro Rehabilitation Teleton- FUNTER Merliot

Antiguo Cuscatlán, 05001, El Salvador

Location

Medical Unit Ilopango -ISSS

Ilopango, 06008, El Salvador

Location

Polyclinic Hospital Planes de Renderos -ISSS

Planes de Renderos, 06015, El Salvador

Location

Regional Hospital San Miguel -ISSS

San Miguel, 12017, El Salvador

Location

Medical Unit 15 de Septiembre -ISSS

San Salvador, 06015, El Salvador

Location

Physical Medicine and Rehabilitation Unit- ISSS

San Salvador, 06015, El Salvador

Location

Foundation Pro Rehabilitation Teleton- FUNTER San Vicente

San Vicente, 10008, El Salvador

Location

Santa Ana's Hospital -ISSS

Santa Ana, 02010, El Salvador

Location

El Salvador's UCP Wheels for Humanity

Santa Tecla, 05009, El Salvador

Location

Foundation Pro Rehabilitation Teleton- FUNTER Sonsonate

Sonsonate, 03014, El Salvador

Location

Sonsonate's Regional Hospital -ISSS

Sonsonate, 03014, El Salvador

Location

Usulutan's Hospital -ISSS

Usulután, 11023, El Salvador

Location

Polyclinic Hospital Zacamil -ISSS

Zacamil, 06009, El Salvador

Location

Study Officials

• Jon Pearlman

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Longitudinal within-subject design

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 23, 2021
• Study Start: January 8, 2019
• Primary Completion: November 25, 2019
• Study Completion: November 25, 2019
• Last Updated: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting after publication
• Access Criteria: All data files will be available from the Inter-university Consortium for Political and Social Research (ICPSR) database. Students, researchers, instructors, staff, and everyone else affiliated with a member institution receives full access to all of ICPSR's data.

Locations

EL (13)