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

Wheelchair Users Clinical Trial

— WUV  

Official title:

Wheelchair User's Voice- A Longitudinal Study About the Impact of the WHO-8 Steps for Wheelchair Provision in El Salvador

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04936087
• Other study ID #: PRO18010578
• Secondary ID: CNEIS/2018/043
• Status: Completed
• Phase: N/A
• Start date: January 8, 2019
• Est. completion date: November 25, 2019

Study information

• Verified date: June 2021
• Source: Momentum Wheels for Humanity
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: November 25, 2019
• Est. primary completion date: November 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wheelchair Users

Intervention

Other:
• 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.

Locations

Country	Name	City	State
El Salvador	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	Usulutan
El Salvador	Polyclinic Hospital Zacamil -ISSS	Zacamil

Sponsors (4)

Lead Sponsor	Collaborator
Momentum Wheels for Humanity	Google LLC., Universidad de El Salvador, University of Pittsburgh

Country where clinical trial is conducted

El Salvador, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	Number of days of wheelchair use	Number of days of wheelchair use	At month 0 (baseline assessment)
Primary	Daily distance traveled	Measured in meters per day	At month 0 (baseline assessment)
Primary	Average speed	Measured in meters per second	At month 0 (baseline assessment)
Primary	Number of days of wheelchair use	Number of days of wheelchair use	At wheelchair delivery (approx. 2 months after baseline assessment)
Primary	Daily distance traveled	Measured in meters per day	At wheelchair delivery (approx. 2 months after baseline assessment)
Primary	Average speed	Measured in meters per second	At wheelchair delivery (approx. 2 months after baseline assessment)
Primary	Number of days of wheelchair use	Number of days of wheelchair use	3 months after wheelchair delivery
Primary	Daily distance traveled	Measured in meters per day	3 months after wheelchair delivery
Primary	Average speed	Measured in meters per second	3 months after wheelchair delivery
Primary	Poverty Probability Index for El Salvador	Poverty probability	At month 0 (baseline assessment)
Primary	Poverty Probability Index for El Salvador	Poverty probability	6 months after wheelchair delivery
Primary	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)
Primary	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	Wheelchair Maintenance Training Questionnaire	The Wheelchair Maintenance Training Questionnaire (WMT-Q) is dedicated to health professionals and users of manual and power wheelchairs. This questionnaire was designed to obtain information about the frequency to which participants performed certain maintenance activities to their wheelchair. For this study only the version for manual wheelchair users was used. WMT-Q has 20 main questions. Possible answers are: "daily" "weekly" "monthly" "quarterly" "annually" "never".	At month 0 (baseline assessment)
Secondary	Wheelchair Maintenance Training Questionnaire	The Wheelchair Maintenance Training Questionnaire (WMT-Q) is dedicated to health professionals and users of manual and power wheelchairs. This questionnaire was designed to obtain information about the frequency to which participants performed certain maintenance activities to their wheelchair. For this study only the version for manual wheelchair users was used. WMT-Q has 20 main questions. Possible answers are: "daily" "weekly" "monthly" "quarterly" "annually" "never".	3 months after wheelchair delivery
Secondary	Wheelchair Maintenance Training Questionnaire	The Wheelchair Maintenance Training Questionnaire (WMT-Q) is dedicated to health professionals and users of manual and power wheelchairs. This questionnaire was designed to obtain information about the frequency to which participants performed certain maintenance activities to their wheelchair. For this study only the version for manual wheelchair users was used. WMT-Q has 20 main questions. Possible answers are: "daily" "weekly" "monthly" "quarterly" "annually" "never".	6 months after wheelchair delivery
Secondary	Zarit Burden Interview - short version	The Zarit Caregiver Burden Questionnaire - short version, or better known as ZBI-12 (Zarit Burden Interview), consists of 12 questions that evaluate the burden of caregivers of people with senile dementia and people with disabilities. The ZBI assesses the caregiver's burden taking into account aspects of the caregiver's life such as family, free time and social activities. This questionnaire can be self-administered, has high content validity, high internal consistency, and great confidence of repetition. The ZBI is available in Spanish, so it can was used in El Salvador as an instrument to measure caregiver burden. ZBI Score range: 0 to 48. The higher the score, the greater the burden of care.	At month 0 (baseline assessment)
Secondary	Zarit Burden Interview - short version	The Zarit Caregiver Burden Questionnaire - short version, or better known as ZBI-12 (Zarit Burden Interview), consists of 12 questions that evaluate the burden of caregivers of people with senile dementia and people with disabilities. The ZBI assesses the caregiver's burden taking into account aspects of the caregiver's life such as family, free time and social activities. This questionnaire can be self-administered, has high content validity, high internal consistency, and great confidence of repetition. The ZBI is available in Spanish, so it can was used in El Salvador as an instrument to measure caregiver burden. ZBI Score range: 0 to 48. The higher the score, the greater the burden of care.	3 months after wheelchair delivery
Secondary	Zarit Burden Interview - short version	The Zarit Caregiver Burden Questionnaire - short version, or better known as ZBI-12 (Zarit Burden Interview), consists of 12 questions that evaluate the burden of caregivers of people with senile dementia and people with disabilities. The ZBI assesses the caregiver's burden taking into account aspects of the caregiver's life such as family, free time and social activities. This questionnaire can be self-administered, has high content validity, high internal consistency, and great confidence of repetition. The ZBI is available in Spanish, so it can was used in El Salvador as an instrument to measure caregiver burden. ZBI Score range: 0 to 48. The higher the score, the greater the burden of care.	6 months after wheelchair delivery
Secondary	Checklist of Activities of Daily Living	The checklist of Activities of Daily Living is a questionnaire designed to collect information about the level of assistance provided to wheelchair users by caregivers in 17 activities of daily living. Possible responses are "Requires no assistance" "Some assistance needed" "Complete assistance needed" and "Not applicable". Responses are reported in number of activities under each level of assistance.	At month 0 (baseline assessment)
Secondary	Checklist of Activities of Daily Living	The checklist of Activities of Daily Living is a questionnaire designed to collect information about the level of assistance provided to wheelchair users by caregivers in 17 activities of daily living. Possible responses are "Requires no assistance" "Some assistance needed" "Complete assistance needed" and "Not applicable". Responses are reported in number of activities under each level of assistance.	3 months after wheelchair delivery
Secondary	Checklist of Activities of Daily Living	The checklist of Activities of Daily Living is a questionnaire designed to collect information about the level of assistance provided to wheelchair users by caregivers in 17 activities of daily living. Possible responses are "Requires no assistance" "Some assistance needed" "Complete assistance needed" and "Not applicable". Responses are reported in number of activities under each level of assistance.	6 months after wheelchair delivery
Secondary	Breakdowns and Adverse Consequences Questionnaire	The Breakdowns and Adverse Consequences Questionnaire (BAC-Q) allows to collect information about the failures that occurred in the wheelchairs. BAC-Q allows knowing the failures in the tires, front wheels, the wheelchair frame, elements of postural support, seat, backrest, cushion, and it gives the opportunity to indicate another type of failure if necessary. By means of this questionnaire it is possible to know the person who carried out the repair and the consequences in the users due to wheelchair breakdowns. For example, being stranded at home or away from home, injuries due to failure, lack of school attendance, work, medical appointments, or other.	At month 0 (baseline assessment)
Secondary	Breakdowns and Adverse Consequences Questionnaire	The Breakdowns and Adverse Consequences Questionnaire (BAC-Q) allows to collect information about the failures that occurred in the wheelchairs. BAC-Q allows knowing the failures in the tires, front wheels, the wheelchair frame, elements of postural support, seat, backrest, cushion, and it gives the opportunity to indicate another type of failure if necessary. By means of this questionnaire it is possible to know the person who carried out the repair and the consequences in the users due to wheelchair breakdowns. For example, being stranded at home or away from home, injuries due to failure, lack of school attendance, work, medical appointments, or other.	At wheelchair delivery (approx. 2 months after baseline assessment)
Secondary	Breakdowns and Adverse Consequences Questionnaire	The Breakdowns and Adverse Consequences Questionnaire (BAC-Q) allows to collect information about the failures that occurred in the wheelchairs. BAC-Q allows knowing the failures in the tires, front wheels, the wheelchair frame, elements of postural support, seat, backrest, cushion, and it gives the opportunity to indicate another type of failure if necessary. By means of this questionnaire it is possible to know the person who carried out the repair and the consequences in the users due to wheelchair breakdowns. For example, being stranded at home or away from home, injuries due to failure, lack of school attendance, work, medical appointments, or other.	3 months after wheelchair delivery
Secondary	Breakdowns and Adverse Consequences Questionnaire	The Breakdowns and Adverse Consequences Questionnaire (BAC-Q) allows to collect information about the failures that occurred in the wheelchairs. BAC-Q allows knowing the failures in the tires, front wheels, the wheelchair frame, elements of postural support, seat, backrest, cushion, and it gives the opportunity to indicate another type of failure if necessary. By means of this questionnaire it is possible to know the person who carried out the repair and the consequences in the users due to wheelchair breakdowns. For example, being stranded at home or away from home, injuries due to failure, lack of school attendance, work, medical appointments, or other.	6 months after wheelchair delivery

External Links

•   Presentation of WUV preliminary results at the Global Research, Innovation, and Education in Assistive Technology (GREAT) Summit held in Geneva on 22-23 August 2019