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.: PACTR201907488398987 Date of Approval: 17/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Diabetes nurse self-management phone call trial in Ghana
Official scientific title Nurse-Led Mobile Phone Intervention to Promote Self-Management in Type 2 Diabetes in Ghana: A Randomised Controlled Trial
Brief summary describing the background and objectives of the trial Daily living with diabetes can be a challenge for many individuals. How to eat, exercise, take medicine, check blood sugar, and care for the feet are daily questions people with diabetes may have. It is important to have continual support from diabetes doctors and nurses to discuss personal issues and set self-care goals and action plans. This study is trying to find out if nurses providing weekly follow-up support through telephone conversation for type 2 diabetes patients with raised HbA1c level helps people with diabetes better care for themselves by following the recommended treatment plan. The main purpose of this study is to compare the effectiveness of regular nurse mobile phone follow-up calls with usual care only in promoting glycaemic control and self-management among type 2 diabetes patients at the Diabetes Centre, KATH. The objectives of the trial include: 1. Measure the impact of nurse-led mobile phone intervention (NMPI) on glycaemic control among T2DM patients in Ghana. 2. Assess the effectiveness of NMPI in promoting adherence to self-management practices among T2DM patients in Ghana. 3. Determine the association between glycaemic control and adherence to self-management practices among T2DM patients in Ghana.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) NMPI trial
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 16/07/2019
Actual trial start date 17/07/2019
Anticipated date of last follow up 30/11/2019
Actual Last follow-up date 31/12/2019
Anticipated target sample size (number of participants) 98
Actual target sample size (number of participants) 98
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group NMPI Self-management follow-up calls as follows: 2 calls per week for the first four (4) weeks, then 1 call weekly for the next nine (9) weeks Three (3) months (13 weeks) Participants in the experimental group will receive three (3) months of nurse-led mobile phone follow-up calls as follows: 2 calls per week for the first four (4) weeks, then 1 call weekly for the next nine (9) weeks. Each call will be scheduled at the convenience of the participant lasting up to 20 minutes although calls may be extended as needed due to pragmatic reasons. Participants will receive 17 calls maximum throughout the intervention period. The content of the calls will include information on diet, exercise, medication taking, self-monitoring of blood glucose, and foot care. Participants will be assisted to set new and evaluate old individualised self-management goals at each call time. This is in addition to usual care where they report to the Diabetes Centre for their scheduled clinic appointments with their diabetes doctors, nurses and dietician which is the current standard care. 49
Control Group Usual care Usual clinic attendance between 1 to 6 months interval as per the patient's diabetes clinic schedule Three (3) months (13 weeks) Control group participants will be reporting to the Diabetes Centre for their scheduled clinic appointments with their diabetes doctors, nurses and dietician which is the current standard care throughout the study period. However, the control group participants will only be given the usual care without any telephone follow up. 49 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants should: 1. be at least 18 years old 2. be diagnosed with type 2 diabetes mellitus 3. have an HbA1C level of >7.0% 4. be taking only oral hypoglycaemic drugs without insulin 5. can communicate in English, and/or Twi languages 6. have access to a personal mobile phone and can answer calls 7. be mentally stable, with no visual, verbal or hearing impairments Participants will be excluded if they are: 1. diagnosed with other comorbidities requiring long hospital stays such as severe cardiovascular diseases, renal failure 2. switched to insulin therapy 3. receiving palliative care 4. diabetes gangrene 5. diabetic ketoacidosis or hyperosmolar non-ketotic coma 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 120 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 27/05/2019 Committee on Human Research Publication and Ethics
Ethics Committee Address
Street address City Postal code Country
School of Medical Sciences KNUST Kumasi 0000 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Glycosylated haemoglobin [HbA1c] levels Baseline and repeated after 13 weeks
Secondary Outcome Self-reported regimen adherence to diet, exercise, medication taking, self-monitoring of blood glucose, and foot care Baseline and repeated after 13 weeks
Secondary Outcome Other clinical characteristics such as body mass index, anthropometric data, blood pressure and lipid profile Baseline and repeated after 13 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Diabetes Centre Komfo Anokye Teaching Hospital Bantama Kumasi Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
School of Nursing and Midwifery Queens University Belfast 97 Lisburn Road Belfast United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor School of Nursing and Midwifery Queens University Belfast 97 Lisburn Road Belfast United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Dr Osei Sarfo Kantanka Komfo Anokye Teaching Hospital Kumasi Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ernest Asante easante01@qub.ac.uk +233503809989 Department of Nursing KNUST
City Postal code Country Position/Affiliation
Kumasi Ghana Lecturer
Role Name Email Phone Street address
Public Enquiries Osei Sarfo Kantanka osarfokantanka21@gmail.com +233208160338 Komfo Anokye Teaching Hospital
City Postal code Country Position/Affiliation
Kumasi Ghana Physician
Role Name Email Phone Street address
Scientific Enquiries Ernest Asante easante01@qub.ac.uk +233503809989 Department of Nursing KNUST
City Postal code Country Position/Affiliation
Kumasi Ghana Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All collected IPD Informed Consent Form,Statistical Analysis Plan,Study Protocol Starting from January 2020 Open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information