The Impact of Environmental Controls on Mental Health
Conditions: Neurologic Disorders
Sponsor: NHS Lothian

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Non-CTIMP Study Protocol 
The impact of environmental controls on mental health 
 
 
Lothian Health Board 
ACCORD 
The Queen’s Medical Research Institute 
47 Little France Crescent 
Edinburgh 
EH16 4TJ 
Protocol authors 
Hannah Gillies and Graham Henderson 
Chief Investigator 
Graham Henderson – Lead Clinical Scientist 
Sponsor number 
AC23092 
REC Number 
23/PR/0917 
Version Number and Date 
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CONTENTS 
 
1 
INTRODUCTION .......................................................................................................... 8 
1.1 
BACKGROUND ................................................................................................... 8 
1.2 
RATIONALE FOR STUDY .................................................................................. 8 
2 
STUDY OBJECTIVES .................................................................................................. 9 
2.1 
OBJECTIVES ...................................................................................................... 9 
2.1.1 
Primary Objective............................................................................................ 9 
2.1.2 
Secondary Objectives ..................................................................................... 9 
2.2 
ENDPOINTS ........................................................................................................ 9 
2.2.1 
Primary Endpoint ............................................................................................ 9 
2.2.2 
Secondary Endpoints ..................................................................................... 9 
3 
STUDY DESIGN ........................................................................................................... 9 
4 
STUDY POPULATION ................................................................................................. 9 
4.1 
NUMBER OF PARTICIPANTS ............................................................................ 9 
4.2 
INCLUSION CRITERIA ....................................................................................... 9 
4.3 
EXCLUSION CRITERIA ...................................................................................... 9 
5 
PARTICIPANT SELECTION AND ENROLMENT ...................................................... 10 
5.1 
IDENTIFYING PARTICIPANTS ......................................................................... 10 
5.2 
CONSENTING PARTICIPANTS ........................................................................ 10 
    5.2.1   Withdrawal of study participants ................................................................. 10 
5.3 
Co-enrolment ................................................................................................... 10 
6 
STUDY ASSESSMENTS ........................................................................................... 10 
6.1 
STUDY ASSESSMENTS ................................................................................... 10 
6.2 
LONG TERM FOLLOW UP ASSESSMENTS ................................................... 11 
6.3 
STORAGE AND ANALYSIS OF SAMPLES ...................................................... 11 
7 
DATA COLLECTION ................................................................................................. 11 
7.1 
Source Data Documentation ........................................................................... 11 
7.2 
Case Report Forms .......................................................................................... 11 
8 
STATISTICS AND DATA ANALYSIS ........................................................................ 11 
8.1 
SAMPLE SIZE CALCULATION ........................................................................ 11 
8.2 
PROPOSED ANALYSES .................................................................................. 11 
9 
ADVERSE EVENTS ......................................................... Error! Bookmark not defined. 
10 
OVERSIGHT ARRANGEMENTS ............................................................................... 12 
10.1 
INSPECTION OF RECORDS ............................................................................ 12 
10.2 
RISK ASSESSMENT ......................................................................................... 12 
10.3 
STUDY MONITORING AND AUDIT .................................................................. 12 
11 
GOOD CLINICAL PRACTICE .................................................................................... 13 
11.1 
ETHICAL CONDUCT......................................................................................... 13 
11.2 
INVESTIGATOR RESPONSIBILITIES .............................................................. 13 

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11.2.1 Informed Consent ......................................................................................... 13 
11.2.2 Study Site Staff ............................................................................................. 13 
11.2.3 Data Recording ............................................................................................. 13 
11.2.4 Investigator Documentation ......................................................................... 13 
11.2.5 GCP Training ................................................................................................. 13 
11.2.6 Confidentiality ............................................................................................... 14 
11.2.7 Data Protection ............................................................................................. 14 
12 
STUDY CONDUCT RESPONSIBILITIES ................................................................... 14 
12.1 
PROTOCOL AMENDMENTS ............................................................................ 14 
12.2 
MANAGEMENT OF PROTOCOL NON COMPLIANCE .................................... 14 
12.3 
SERIOUS BREACH REQUIREMENTS ............................................................. 15 
12.4 
STUDY RECORD RETENTION ......................................................................... 15 
12.5 
END OF STUDY ................................................................................................ 15 
12.6 
CONTINUATION OF TREATMENT FOLLOWING THE END OF 
STUDY .............................................................................................................. 15 
12.7 
INSURANCE AND INDEMNITY ........................................................................ 15 
13 
REPORTING, PUBLICATIONS AND NOTIFICATION OF RESULTS ........................ 16 
13.1 
AUTHORSHIP POLICY ..................................................................................... 16 
14 
REFERENCES ........................................................................................................... 16 
 

 
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LIST OF ABBREVIATIONS 
 
 
ACCORD 
Academic and Clinical Central Office for Research & Development - Joint office 
for The University of Edinburgh and Lothian Health Board 
CI 
Chief Investigator 
CRF 
Case Report Form 
ECS 
Environmental Control Service 
GCP 
Good Clinical Practice 
ICH 
International Conference on Harmonisation 
PI 
Principal Investigator 
QA 
Quality Assurance 
REC 
Research Ethics Committee 
SOP 
Standard Operating Procedure 

 
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1 
INTRODUCTION 
1.1 
BACKGROUND 
 
Within the UK there are over 15 million people who live with at least one long term condition. 
Of these people, over 4 million suffer from mental health problems (Naylor C. 2012). A study 
by Emerson et al (2009) found that people with disabilities have poorer mental health than 
their counterparts.  
 
Environmental control systems are a type of assistive technology that can be controlled by a 
wide variety of different access methods (e.g. switches) and can assist people with physical 
disabilities to control various electronic devices in the home environment.  The systems are 
designed to provide independence, removing the requirement to be reliant on other people 
(for the operation of the controlled devices) and potentially could have a positive effect on 
mental health and quality of life. 
 
A systematic review carried out by Brandt et al. (2010) concluded that there was not enough 
evidence to conclusively say that environmental control systems improve outcomes for 
patients.  Whilst the review did not specifically investigate mental health outcomes it did look 
at quality of life and user satisfaction.  There is a paucity of studies specifically focusing on 
mental health outcomes.  A study by Squires et al. (2021) did include some mental health 
outcome measures. However, it was a case study with one participant and it is therefore not 
possible to draw any conclusions for a wider population.  This project aims to address the 
issues above by determining the impact of environmental control systems on mental health by 
recording outcome measures pre and post intervention.  
 
 
1.2 
RATIONALE FOR STUDY 
The research question for this study is to determine impact of environmental controls 
on mental health. It is hypothesised that there will be a positive impact on mental health of the 
participants. 
 
This study will contribute to an evidence base for the importance and value of environmental 
control systems.  This evidence base can be used as part of a review of the NHS Scotland 
service provision of environmental controls and writing and implementing a national service 
specification for environmental controls in Scotland.    
 
2 
STUDY OBJECTIVES 
2.1 
OBJECTIVES 
2.1.1 Primary Objective 
To explore the impact of environmental controls on the user’s mental health and quality of life. 
 
2.2 
ENDPOINTS 
2.2.1 Primary Endpoint 

 
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The co-primary endpoints are the PROMIS Global10 and PIADS-10 measures.  
 
NB due to predicted low participant numbers this study has not been powered to assess 
these endpoints.  Instead the data will be analysed with descriptive methods with a focus on 
clinical significance. 
 
3 
STUDY DESIGN 
Case series (follow-up) design.  Participants will be involved from their assessment until 8 
weeks after device provision. The full duration of involvement will vary depending on 
assessment wait times and availability of required intervention. The study will take place in 
the participant’s home.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4 
STUDY POPULATION 
4.1 
NUMBER OF PARTICIPANTS 
The participants will be recruited from the population served by NHS Lothian’s Environmental 
Control Service.  The number of participants will be determined by how many participants it is 
possible to recruit within 12 months – it is expected to be <10. The participants will be referred 
to service as normal and the clinical intervention (supply of an environmental control system) 
will proceed irrespective of their participation or otherwise in the study. The only difference to 
the normal service provision and pathway is the application of the baseline and follow up 
questionnaires.  
Patient referral received for ECS.  
Personal data (Phone number) 
used to contact patient to set up 
assessment 
Initial Patient assessment 
(Pre- intervention questionnaire) 
ECS intervention implemented.  
Follow up phone call 3 weeks 
after implementation (Post- 
intervention questionnaire)   
Follow up phone call 8 weeks 
after implementation (Post- 
intervention questionnaire)   

 
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4.2 
INCLUSION CRITERIA 
i. 
Eligible for an environmental control system (age 18-80).   
ii. 
New user (no previous intervention).  
iii. 
Neurological condition. 
iv. 
Cognitive ability to answer the questions and to give consent.  
 
4.3 
EXCLUSION CRITERIA 
i. 
Previous environmental control intervention   
ii. 
Patients requiring equipment not supplied by NHS Lothian’s ECS (e.g. 
door interface)  
iii. 
Patient recently diagnosed (within 6 months)  
iv. 
Rapidly deteriorating condition  
 
4.4 
CO-ENROLMENT 
 
Co-enrolment will not be allowed in any circumstances. 
5 
PARTICIPANT SELECTION AND ENROLMENT 
5.1 
IDENTIFYING PARTICIPANTS 
Participants will be identified by Clinical Scientists working in NHS Lothian’s Environmental 
Control Service (ECS). The patient will be contacted by a Clinical Scientist via telephone, to 
arrange an environmental control assessment, at which point they will be approached to join 
the study.  
 
5.2 
CONSENTING PARTICIPANTS 
Informed consent will be collected by a Clinical Scientist at the assessment appointment in 
the form of a consent form. The participants will be sent the information sheet at least 1 week 
in advance of the assessment appointment.  
 
5.2.1 Withdrawal of Study Participants 
Participants are free to withdraw from the study at any point or a participant can be withdrawn 
by the Investigator. If withdrawal occurs, the primary reason for withdrawal will be 
documented in the participant’s case report form, if possible. The participant will have the 
option of withdrawal from: 
  
(i) all aspects of the trial but continued use of data collected up to that point. To safeguard 
data protection and confidentiality, the minimum personally-identifiable information possible 
will be collected. 
 
 
 
 
 

 
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6 
STUDY ASSESSMENTS 
6.1 
STUDY ASSESSMENTS 
The intervention provided will be dependent on the patients’ needs however it will comprise of 
an electronic environmental control system which will help them to access devices around 
their home independently.  An example system would consist of a controller (e.g. Qwayo 2) 
with a switch and mounting system and any additional peripherals (e.g. remote controlled 
sockets).  The assessment for the system will take place first and can take between 30-60 
minutes.  Questionnaires will be completed afterwards and will take approximately 30 minutes 
to complete.  
 
Assessment  
Screening  
Baseline  
(Assessment) 
3 weeks 
following 
provision  
8 weeks 
following 
provision  
Assessment of Eligibility 
Criteria  
 
  
  
  
Written informed consent  
 
  
  
  
Demographic data (name, 
age, address) contact details  
 
 
 
 
Questionnaire  
 
 
   
       
 
6.2 
LONG TERM FOLLOW UP ASSESSMENTS 
The longest follow up will be 8 weeks. 
7 
DATA COLLECTION 
All data will be collected by a Clinical Scientist within NHS Lothian’s Environmental Control 
Service.  
 
1. Participant will complete pre-intervention questionnaire PROMIS Global10- score, 
PIADS-10 and study specific questions (completed in person at assessment)  
2. Intervention with environmental control equipment (prescription dependant on 
patient requirements)  
3. Participant will complete post intervention questionnaire PROMIS Global10- 
score, PIADS-10 and study specific questions (3 weeks)  (follow up over 
phone) 
4. Participant will complete post intervention questionnaire PROMIS Global10- 
score, PIADS-10 and study specific questions (8 weeks)  (follow up over 
phone) 
7.1 
Source Data Documentation 
1. PIADS10 Questionnaire.  
2. PROMIS Global 10 Questionnaire. 
3. Study Specific Questions Questionnaire. 

 
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7.2 
Case Report Forms 
Collect data on structured form – will be transcribed onto database (spreadsheet). 
Handwritten forms will be kept locked in cabinet.  
8 
DATA MANAGEMENT 
8.1.1 Personal Data 
The following personal data will be collected as part of the research: 
• 
Name, ReTIS number (this is 6 digit identifier used by the ReTIS database – the 
system used for patient management within the SMART Centre for issuing 
wheelchairs and environmental control systems etc.), Phone number, Home address, 
health conditions.  This information is collected from the patient’s referral form.  
 
Personal data will be stored by the research team on ReTIS (Local data management 
software) which is password protected. A mapping spreadsheet will be created to map 
between the ReTIS number and the participant’s study specific code. Personal data will be 
stored for as long as they are a patient of the Environmental Control Service.  
8.1.2 
Data Information Flow 
 
 
 
 
 
 
 
 
 
 
Participant joins study  
 
 
 
 
 
 
 
 
 
 
 
End of patient participation  
 
 
 
 
 
 
* After a fixed period in accordance with the retention of health records requirements. 
 
Referral received 
containing 
personal data  
Existing patient on 
ReTIS  
Personal data (Phone number) 
used to contact patient to set 
up assessment   
Personal data (Home address) 
used to contact patient to set 
up assessment   
Personal data (Phone number) 
used to contact patient to follow 
up / questionnaire 
Personal data 
deleted when 
patient leaves 
the service*   
Personal data kept 
on ReTIS whilst 
patient continues 
to receive care 
from the service   

 
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8.1.3 
Transfer of Data 
Data collected or generated by the study (including personal data) will not be transferred to 
any external individuals or organisations outside of the Sponsoring organisation(s).  
 
8.1.4 
Data Controller 
A data controller is an organisation that determines the purposes for which, and the manner in 
which, any personal data are processed. 
NHS Lothian are data controller along with any other entities involved in delivering the study 
that may be a data controller in accordance with applicable laws (e.g. the site) 
8.1.5 
Data Breaches 
Any data breaches will be reported to the NHS Lothian Data Protection Officer who will 
onward report to the relevant authority according to the appropriate timelines if required. 
9 
STATISTICS AND DATA ANALYSIS 
9.1 
SAMPLE SIZE CALCULATION 
Due to the data will analysed with descriptive methods no sample size calculations are 
required. 
9.2 
PROPOSED ANALYSES 
Incomplete datasets will be removed before undertaking the analysis. 
 
The data will be analysed with descriptive methods with a focus on clinical significance.  
Correlation analysis will be conducted to determine relationships between the device use and 
social context and the mental health outcome measures.  
For all of the outcome measures the following data will be reported: mean, change in mean 
between intervals and standard deviation.  
Spearman Rank Correlation Coefficient will be used to test the significance of the relationship 
between variables. 
 
10 
OVERSIGHT ARRANGEMENTS 
10.1 INSPECTION OF RECORDS 
Investigators and institutions involved in the study will permit trial related monitoring and 
audits on behalf of the sponsor, REC review, and regulatory inspection(s).  In the event of 
audit or monitoring, the Investigator agrees to allow the representatives of the sponsor direct 
access to all study records and source documentation. In the event of regulatory inspection, 
the Investigator agrees to allow inspectors direct access to all study records and source 
documentation. 
10.2 STUDY MONITORING AND AUDIT 
The ACCORD Sponsor Representative will assess the study to determine if an independent 
risk assessment is required.  If required, the independent risk assessment will be carried out 
by the ACCORD Quality Assurance Group to determine if an audit should be performed 
before/during/after the study and, if so, at what frequency. 
 

 
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Risk assessment, if required, will determine if audit by the ACCORD QA group is required. 
Should audit be required, details will be captured in an audit plan. Audit of Investigator sites, 
study management activities and study collaborative units, facilities and 3rd parties may be 
performed. 
11 
GOOD CLINICAL PRACTICE 
11.1 ETHICAL CONDUCT 
The study will be conducted in accordance with the principles of the International Conference 
on Harmonisation Tripartite Guideline for Good Clinical Practice (ICH GCP).Before the study 
can commence, all required approvals will be obtained and any conditions of approvals will be 
met. 
11.2 INVESTIGATOR RESPONSIBILITIES 
The Investigator is responsible for the overall conduct of the study at the site and compliance 
with the protocol and any protocol amendments.  In accordance with the principles of ICH 
GCP, the following areas listed in this section are also the responsibility of the Investigator.  
Responsibilities may be delegated to an appropriate member of study site staff.   
Delegated tasks must be documented on a Delegation Log and signed by all those named on 
the list prior to undertaking applicable study-related procedures.  
11.2.1 Informed Consent 
The Investigator is responsible for ensuring informed consent is obtained before any protocol 
specific procedures are carried out. The decision of a participant to participate in clinical 
research is voluntary and should be based on a clear understanding of what is involved. 
Participants must receive adequate oral and written information – appropriate Participant 
Information and Informed Consent Forms will be provided. The oral explanation to the 
participant will be performed by the Investigator or qualified delegated person, and must cover 
all the elements specified in the Participant Information Sheet and Consent Form. 
The participant must be given every opportunity to clarify any points they do not understand 
and, if necessary, ask for more information. The participant must be given sufficient time to 
consider the information provided.  It should be emphasised that the participant may withdraw 
their consent to participate at any time without loss of benefits to which they otherwise would 
be entitled. 
The Investigator or delegated member of the trial team and the participant will sign and date 
the Informed Consent Form(s) to confirm that consent has been obtained. The participant will 
receive a copy of this document and a copy filed in the Investigator Site File (ISF) and 
participant’s medical notes (if applicable). 
11.2.2 Study Site Staff 
The Investigator must be familiar with the protocol and the study requirements.  It is the 
Investigator’s responsibility to ensure that all staff assisting with the study are adequately 
informed about the protocol and their trial related duties. 
 
 
11.2.3 Data Recording 
The Principal Investigator is responsible for the quality of the data recorded in the CRF at 
each Investigator Site.  

 
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11.2.4  Investigator Documentation 
• 
The Principal Investigator will ensure that the required documentation is available in 
local Investigator Site files ISFs.  
11.2.5 GCP Training 
For non-CTIMP (i.e. non-drug) studies all researchers are encouraged to undertake GCP 
training in order to understand the principles of GCP. However, this is not a mandatory 
requirement unless deemed so by the sponsor.  GCP training status for all investigators 
should be indicated in their respective CVs.  
11.2.6 Confidentiality 
All laboratory specimens, evaluation forms, reports, and other records must be identified in a 
manner designed to maintain participant confidentiality.  All records must be kept in a secure 
storage area with limited access.  Clinical information will not be released without the written 
permission of the participant.  The Investigator and study site staff involved with this study 
may not disclose or use for any purpose other than performance of the study, any data, 
record, or other unpublished information, which is confidential or identifiable, and has been 
disclosed to those individuals for the purpose of the study.  Prior written agreement from the 
sponsor or its designee must be obtained for the disclosure of any said confidential 
information to other parties. 
11.2.7 Data Protection 
All Investigators and study site staff involved with this study must comply with the 
requirements of the appropriate data protection legislation (including the General Data 
Protection Regulation and Data Protection Act) with regard to the collection, storage, 
processing and disclosure of personal information.  
Computers used to collate the data will have limited access measures via user names and 
passwords. 
 
Published results will not contain any personal data and be of a form where individuals are 
not identified and re-identification is not likely to take place. 
STUDY CONDUCT RESPONSIBILITIES 
11.3 PROTOCOL AMENDMENTS 
Any changes in research activity, except those necessary to remove an apparent, immediate 
hazard to the participant in the case of an urgent safety measure, must be reviewed and 
approved by the Chief Investigator.   
Amendments will be submitted to a sponsor representative for review and authorisation 
before being submitted in writing to the appropriate REC, and local R&D for approval prior to 
participants being enrolled into an amended protocol. 
11.4 MANAGEMENT OF PROTOCOL NON COMPLIANCE 
Prospective protocol deviations, i.e. protocol waivers, will not be approved by the sponsors 
and therefore will not be implemented, except where necessary to eliminate an immediate 
hazard to study participants. If this necessitates a subsequent protocol amendment, this 
should be submitted to the REC, and local R&D for review and approval if appropriate. 
Protocol deviations will be recorded in a protocol deviation log and logs will be submitted to 
the sponsors every 3 months. Each protocol violation will be reported to the sponsor within 3 

 
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days of becoming aware of the violation.  All protocol deviation logs and violation forms 
should be emailed to QA@accord.scot 
Deviations and violations are non-compliance events discovered after the event has occurred.  
Deviation logs will be maintained for each site in multi-centre studies.  An alternative 
frequency of deviation log submission to the sponsors may be agreed in writing with the 
sponsors. 
 
11.5 SERIOUS BREACH REQUIREMENTS 
A serious breach is a breach which is likely to effect to a significant degree: 
(a) the safety or physical or mental integrity of the participants of the trial; or 
(b) the scientific value of the trial. 
If a potential serious breach is identified by the Chief investigator, Principal Investigator or 
delegates, the co-sponsors (seriousbreach@accord.scot) must be notified within 24 hours.  It 
is the responsibility of the co-sponsors to assess the impact of the breach on the scientific 
value of the trial, to determine whether the incident constitutes a serious breach and report to 
research ethics committees as necessary.  
11.6 STUDY RECORD RETENTION 
All study documentation will be kept for a minimum of 3 years from the protocol defined end of 
study point. When the minimum retention period has elapsed, study documentation will not be 
destroyed without permission from the sponsor. 
11.7 END OF STUDY 
The end of study is defined as the last participant’s last visit.   
The Investigators or the co-sponsor(s) have the right at any time to terminate the study for 
clinical or administrative reasons.  
The end of the study will be reported to the REC, and R+D Office(s) and co-sponsors within 
90 days, or 15 days if the study is terminated prematurely. The Investigators will inform 
participants of the premature study closure and ensure that the appropriate follow up is 
arranged for all participants involved. End of study notification will be reported to the co-
sponsors via email to resgov@accord.scot 
A summary report of the study will be provided to the REC within 1 year of the end of the 
study. 
 
11.8 CONTINUATION OF TREATMENT FOLLOWING THE END OF 
STUDY 
Detail if intervention will be continued to be provided following the end of the study.  If not 
provide justification 
The participant will continue to be provided their environmental control device in line with NHS 
Lothian’s service provision.  
11.9 INSURANCE AND INDEMNITY 
The Sponsor is responsible for ensuring proper provision has been made for insurance or 
indemnity to cover their liability and the liability of the Chief Investigator and staff. 
The following arrangements are in place to fulfil the Sponsors' responsibilities: 

 
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• 
Sites participating in the study will be liable for clinical negligence and other 
negligent harm to individuals taking part in the study and covered by the duty of care 
owed to them by the sites concerned.  The co-sponsors require individual sites 
participating in the study to arrange for their own insurance or indemnity in respect 
of these liabilities. 
• 
Sites which are part of the United Kingdom's National Health Service will have the 
benefit of NHS Indemnity. 
• 
 
12 
REPORTING, PUBLICATIONS AND NOTIFICATION OF 
RESULTS 
12.1 AUTHORSHIP POLICY 
Ownership of the data arising from this study resides with the study team.   
13 
REFERENCES 
Brandt A, Samuelsso K, Toytari O, Salminen A-L. Activity and participation, quality of life and 
user satisfaction outcomes of environmental control systems and smart home technology: a 
systematic review. Disability and Rehabilitation: Assistive Technology 2011:6;189-206 
 
Naylor, C, Parsonage, M, McDaid, D, Knapp, M, Fossy, M., Galea, A. Long-term 
conditions and mental health – The cost of co-morbidities. London: The King’s Fund, & 
Centre for Mental Health. 2012 
 
Emerson E, Honey A, Madden R, Llewellyn G. The well-being of Australian adolescents and 
young adults with self-reported long-term health conditions, impairments or disabilities: 2001 
and 2006. Aust J Soc Issues 2009: 44;39–53. 
 
Squires LA, Rush F, Hopkinson A, Val M. The physical and psychological impact of using a 
computer-based environmental control system: a case study. Disability and Rehabilitation: 
Assistive Technology 2013: 8:5; 434-443.