| CTRI Number |
CTRI/2021/06/034311 [Registered on: 18/06/2021] Trial Registered Prospectively |
| Last Modified On: |
11/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
EFFECT OF HEALTH EDUCATION INTERVENTION ON FOOT SELF-CARE BEHAVIOR |
|
Scientific Title of Study
|
EFFECT OF HEALTH EDUCATION INTERVENTION ON FOOT SELF-CARE BEHAVIOR AMONG DIABETIC PATIENTS IN UNIVERSITY TEACHING HOSPITAL NIGERIA
The scientific title match the study site, the ethical clearance I submitted to you is from my university, like I mentioned before, I am a PhD student so my university issued the ethical clearance, my study location is UNIVERSITY TEACHING HOSPITAL NIGERIA, UNIVERSITY TEACHING HOSPITAL NIGERIA will issue ethical clearance same week I will start my data collection. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
EMILIA Oluchi Sampson PhD student |
| Designation |
Malaysia |
| Affiliation |
University Teaching hospital Nigeria |
| Address |
Department of Community Health
Faculty of Medicine & Health Sciences
Universiti Putra Malaysia
43400
Other |
| Phone |
0122578997 |
| Fax |
|
| Email |
oluzuby@yahoo.ca |
|
Details of Contact Person
Scientific Query
|
| Name |
Assoc Prof Dr Rosliza Abdul |
| Designation |
Malaysia |
| Affiliation |
University Putra Malaysia |
| Address |
Department of Community Health
Faculty of Medicine & Health Sciences
Universiti Putra Malaysia
MALAYSIA
43400
Other |
| Phone |
603-89472404 |
| Fax |
|
| Email |
rosliza_abmanaf@upm.edu.my |
|
Details of Contact Person
Public Query
|
| Name |
EMILIA Oluchi Sampson |
| Designation |
Malaysia |
| Affiliation |
University Putra Malaysia |
| Address |
Department of Community Health
Faculty of Medicine & Health Sciences
Universiti Putra Malaysia
43400
Other |
| Phone |
0122578997 |
| Fax |
|
| Email |
oluzuby@yahoo.ca |
|
|
Source of Monetary or Material Support
|
| Rowland
University Teaching hospital Nigeria, University Teaching hospital Nigeria, Idi-Araba, Nigeria.
chuksmars@yahoo.co.uk |
| University Teaching hospital Nigeria, University Teaching hospital Nigeria, Idi-Araba, Nigeria |
|
|
Primary Sponsor
|
| Name |
Emilia |
| Address |
segar view, Malaysia |
| Type of Sponsor |
Other [self sponsor] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nwachukwu Okechukwu Nnorom |
Block Q unit 2b road 20, Lekki gardens estate. Lekki Epe Express way opposite Abraham Adesanya Estate. Ajah Lagos |
|
|
Countries of Recruitment
|
Nigeria
Malaysia |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Assoc Prof Dr Rosliza Abdul |
University Teaching Hospital Nigeria ( Only one site is to be used) |
University Teaching Hospital Nigeria, Idi-Araba, Surulere, Lagos State Nigeria, department of medicine.
|
603-89472404
rosliza_abmanaf@upm.edu.my |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethical communitee federal medical centre, Owerri Nigeria |
Approved |
| Ethics Committee for Research involving Human Subjects of University Putra Malaysia (JKEUPM) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E13||Other specified diabetes mellitus, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control and Intervention |
Respondents of the control
group will receive usual clinic
care and placebo |
| Intervention |
Control and Intervention |
The two groups are the
intervention group and the
control group. Respondents of
the Intervention group will
receive health education in
addition to usual clinic care A
total of four sessions and thirty
minutes in each session. The duration of the intervention is six months. Total duration is two hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All diabetes patients age 18 years and above, who attend the diabetes clinic for usual follow-up in university teaching hospital, Nigeria.
Diabetes patients presented with or without diabetic foot problem.
|
|
| ExclusionCriteria |
| Details |
Patients with history of mental health condition.
Patients with visual or hearing impairment.
Patients with extreme diabetes complication, diabetic patients admitted in the ward due to complicated diabetes.
Diabetes patients with amputated both legs
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| foot self-care behavior |
To determine the changes within intervention group from baseline to 3 and 6 months for post intervention.
To compare the changes between intervention group and control group from baseline at 3 and 6 months for post intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes: knowledge of foot care, foot care self-efficacy and health belief model (HBM) construct |
three months and six months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="0"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/09/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. it is the fifth leading cause of death globally, accounting for 4.6 million suffering yearly. diabetes of all types is the leading cause of complications in many part of the body including foot ulcers and increases the risk of dying prematurely.
The aim of this trial is to develop a patient education intervention program on foot care and to determine the effectiveness of patients education intervention on foot foot self-care behaviour and clinical outcomes among diabetic patients in University Teaching Hospital Nigeria.
This study, being conducted as part of PhD thesis work, is registered in Malaysia and is to be conducted in Nigeria
|