Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201801002977974 Date of Registration: 15/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Enhancing Palliative Care
Official scientific title Enhancing Palliative Care in Rural South-East Nigeria: Use of a Mobile App for Symptom Management
Brief summary describing the background and objectives of the trial The specific cancer control problem being addressed is non-timely and inadequate symptom control for cancer patients. Pain & Palliative Care Unit of UNTH, attends to patients in South-East Nigeria on out-patient basis at least once a month with phone calls made once a month by unit to each patient. Many patients living in the rural areas default from follow-up visits; those who do not default make requests to be given long appointments citing transportation difficulties, far distances from rural abode to hospital and lack of finances as reasons. Also, some patients develop poor/non-compliance to prescribed medications making symptom management difficult. In addition, nurses in team have difficulty eliciting accurate information about patients symptoms during crisis using phone calls (telephone-mediated care/teletriage) and many patients end up deteriorating/dying before they can get valuable medical help, especially during ¿out-of-hours¿ (after 4pm daily, weekends). Use of mobile app to monitor symptoms in addition to their pre-scheduled hospital appointments will ensure best form of prompt intervention in symptom management, especially when compared with telephone-mediated care added to pre-scheduled hospital appointments and when compared with pre-scheduled hospital appointments only, leading to significant improvement with patient symptom management, patient compliance with appointments, medication use and medical instructions, improvement in patients¿ quality of life, satisfaction with palliative care received and reduction of family caregiver burden.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EPAC
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/03/2017
Actual trial start date 15/04/2017
Anticipated date of last follow up 01/11/2017
Actual Last follow-up date 31/12/2017
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
UNTH/CSA/329/Vol.5.NHREC/05/01/2008B Univerity of Nigeria Teaching Hospital Research and Ethics Committee Approval
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group App group 3 months Daily reports sent via mobile phone app twice daily, minimum once daily; reminder by assigned nurse via phone call; monthly pre-scheduled clinic visits; Evaluation of Quality of life, Patient satisfaction with care, Family caregiver burden 40
Experimental Group Phone call group 3 months Daily phone calls made to patient by assigned palliative care nurse, in addition to monthly pre-scheduled clinic visits and assessment ofQuality of life, Patient satisfaction with care recieved and Family caregiver burden; family caregivers assessed where present 40
Control Group Control group 3 months patients assigned to this group given initial month pre-scheduled appointments; no follow-up calls or contact by assigned nurse for subsequent visits except for patients who honour preceding appointment 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Consenting adults (>/=18 years) Cancer outpatients referred to and enrolled with Pain and Palliative Care Unit of study hospital. Either rural dwellers living in villages surrounding or distant to the hospital or reside outside the state (Enugu) where the hospital is domiciled. Required to speak and read English or have a family caregiver living with them who speaks and reads English. Required to have a minimum educational level of primary school education or have at least one (1) family caregiver with minimum of primary school education. Possess a mobile phone or the ability to use a mobile phone or family caregiver with mobile phone or ability to use a mobile phone. Access to mobile network in place of abode. Access to electricity in their abode. Patients who are unable to meet the above criteria Paediatric patients Patient who refused to being enrolled into the study 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/03/2017 University of Nigeria Teaching Hospital Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ituku-Ozalla Enugu PMB 01129 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Impact on palliative care delivery once a month
Secondary Outcome Quality of life Once a month
Secondary Outcome Patient satisfaction with care Once a month
Secondary Outcome Family caregiver satisfaction Once a month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pain & Palliative Care Unit Ituku-Ozalla Enugu PMB 01129 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Conquer Cancer Foundation of the American Society of Clinical Oncology 2318 Mill Road, Suite 800 Alexandria, VA 22314 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Conquer Cancer Foundation of the American Society of Clinical Oncology (ASCO) 2318 Mill Road, Suite 800 Alexandria, VA 22314 United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Dr Tonia C Onyeka Ituku-Ozalla Enugu PMB 01129 Nigeria
Dr I.C. Ugwu Ituku-Ozalla Enugu PMB 01129 Nigeria
Dr N, Iloanusi Ituku-Ozalla Enugu PMB 01129 Nigeria
Dr C.C. Chigbu Ituku-Ozalla Enugu PMB 01129 Nigeria
Dr C. Logie Maryland Baltimore 21237 United States of America
Dr. M.O. Nwaneri 1305 Hembree Road Roswell, Georgia 30076 United States of America
Dr S. Ikenga Ituku-Ozalla Enugu PMB 01129 Nigeria
Mrs. C. Ubah Ituku-Ozalla Enugu PMB 01129 Nigeria
Mrs. D. Ekewuba Ituku-Ozalla Enugu PMB 01129 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tonia Onyeka tonia.onyeka@unn.edu.ng +2348063563223
City Postal code Country Position/Affiliation
Enugu Nigeria College of Medicine, University of Nigeria
Role Name Email Phone Street address
Principal Investigator TONIA ONYEKA tonia.onyeka@unn.edu.ng +2348063563223 Ituku-Ozalla
City Postal code Country Position/Affiliation
Enugu PMB 01129 Nigeria College of Medicine, University of Nigeria
Role Name Email Phone Street address
Principal Investigator TONIA ONYEKA tonia.onyeka@unn.edu.ng +2348063563223 Ituku-Ozalla
City Postal code Country Position/Affiliation
Enugu PMB 01129 Nigeria College of Medicine, University of Nigeria
Role Name Email Phone Street address
Principal Investigator Tonia Onyeka tonia.onyeka@unn.edu.ng +2348063563223 Ituku-Ozalla
City Postal code Country Position/Affiliation
Enugu PMB 01129 Nigeria College of Medicine, University of Nigeria
Role Name Email Phone Street address
Public Enquiries Innocent Ugwu talktomedrugwu@yahoo.com +2348033648038 Ituku-Ozalla
City Postal code Country Position/Affiliation
Enugu PMB 01129 Nigeria University of Nigeria Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Innocent Ugwu talktomedrugwu@yahoo.com +2348033648038 Ituku-Ozalla
City Postal code Country Position/Affiliation
Enugu PMB 01129 Nigeria University of Nigeria Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Innocent Ugwu talktomedrugwu@yahoo.com +2348033648038
City Postal code Country Position/Affiliation
Enugu Nigeria
Role Name Email Phone Street address
Scientific Enquiries Tonia Onyeka tonia.onyeka@unn.edu.ng +2348063563223 Ituku-Ozalla
City Postal code Country Position/Affiliation
Enugu PMB 01129 Nigeria College of Medicine, University of Nigeria
REPORTING
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