| CTRI Number |
CTRI/2020/07/026828 [Registered on: 27/07/2020] Trial Registered Prospectively |
| Last Modified On: |
27/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Evaluating the efficiency of competency training for ASHA workers in Type 2 Diabetes |
Scientific Title of Study
Modification(s)
|
EVALUATION OF COMPETENCE TRAINING FOR THE MINIMALLY TRAINED HEALTH WORKER IN TYPE 2 DIABETES: A CLUSTER RANDOMIZED CONTROLLED TRIAL |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anirudh Gaurang Gudlavalleti |
| Address |
Indian Institute of Public Health Hyderabad
Plot no 1, Road Number 44,
Masthan Nagar, Kauri Hills,
Madhapur,
Hyderabad
Hyderabad
TELANGANA
500033
India |
| Phone |
|
| Fax |
|
| Email |
anirudh.g@iiphh.org |
|
Details Contact Person
Scientific Query
|
| Name |
Anirudh Gaurang Gudlavalleti |
| Address |
Indian Institute of Public Health Hyderabad
Plot no 1, Road Number 44,
Masthan Nagar, Kauri Hills,
Madhapur,
Hyderabad
TELANGANA
500033
India |
| Phone |
|
| Fax |
|
| Email |
anirudh.g@iiphh.org |
|
Details Contact Person
Public Query
|
| Name |
Prof Giridhara R Babu |
| Address |
Magadi Rd 1st cross, Next to leprosy hospital, SIHFW premises, Bengaluru,
Bangalore
KARNATAKA
560023
India |
| Phone |
|
| Fax |
|
| Email |
giridhar@iiphh.org |
|
|
Source of Monetary or Material Support
|
| Indian Institute of Public Health Hyderabad |
|
Primary Sponsor
Modification(s)
|
| Name |
Anirudh Gaurang Gudlavalleti |
| Address |
Indian Institute of Public Health Hyderabad,
Plot No 1, Road Number 44, Masthan Nagar, Kavuri Hills,
Madhapur
Hyderabad-500033 |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof Giridhara R Babu |
Magadi Rd 1st cross, Next to leprosy hospital, SIHFW premises, Bengaluru, Karnataka 560023 |
| Pushpagiri Vitreoretinal Institute |
Plot No 241, Uma Plaza, 9, Gupta Enclave, Aswini Colony, West Marredpally, Secunderabad- 500026 |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anirudh |
Basti Dawakhana Allaudin Koti |
Sanathnagar Zone,
Hyderabad
Hyderabad
|
8008799816
anirudh.g@iiphh.org |
| Anirudh |
Basti Dawakhana Chintabavi |
Mettuguda Zone,
Hyderabad
Hyderabad
|
8008799816
anirudh.g@iiphh.org |
| Anirudh |
Basti Dawakhana Ganganagar |
Harajpenta (Amberpet) Zone,
Hyderabad
Hyderabad
|
8008799816
anirudh.g@iiphh.org |
| Anirudh |
Basti Dawakhana Mutyalambagh |
Hyderguda,
Gaganmahal Zone,
Hyderabad
Hyderabad
|
8008799816
anirudh.g@iiphh.org |
| Anirudh |
Basti Dawakhana Narsimha Basti |
Tilaknagar Zone,
Hyderabad
Hyderabad
|
8008799816
anirudh.g@iiphh.org |
| Anirudh |
Primary Health Centre Abdullapurmet |
Abullapurmet Village,
Rangareddy District
Hyderabad
Hyderabad
|
8008799816
anirudh.g@iiphh.org |
| Anirudh |
Primary Health Centre Balapur |
Lenin Nagar Rd, Sri Sai Balaji Town Ship, Meerpet, Hyderabad, Telangana 500058
Hyderabad
|
8008799816
anirudh.g@iiphh.org |
| Anirudh |
Primary Health Centre Saroornagar |
536, 11-5-535, Rd Number 16, Sri Venkateshwara Colony, Saroornagar, Hyderabad, Telangana 500035
Hyderabad
|
8008799816
anirudh.g@iiphh.org |
| Anirudh |
Primary Health Centre Serilingampalli |
Gulmohar Park Cross Road, opposite Andhra Bank, Adarsh Nagar, Serilingampally, Hyderabad, Telangana 500019
Hyderabad
|
8008799816
anirudh.g@iiphh.org |
| Anirudh |
Primary Health Centre Sivarampalli |
Aramgarh Side, Sivarampalli Village,
Hyderabad
Hyderabad
|
8008799816
anirudh.g@iiphh.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Indian Institute of Public Health Hyderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Training of participants on Type 2 diabetes mellitus |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Control group will not receive any extra training and continue screening and managing patients with type 2 diabetes mellitus according to the NPCDCS guidelines |
| Intervention |
Type 2 Diabetes Mellitus Training for ASHA workers |
Type 2 Diabetes Mellitus Training for ASHA workers, to be conducted for 20 hours to assess change in their competency levels |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Female health workers employed as accredited social health activists (ASHA) in the villages under the 8 chosen centres
2. Health workers living within a radius of 40kms from the identified health centres
|
|
| ExclusionCriteria |
| Details |
i. Pregnant health workers
ii. Health workers unwilling/unable to provide written informed consent.
iii. Health workers with terminal illnesses
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Competency of ASHA workers |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Competency of ASHA workers |
2 years follow-up |
|
|
Target Sample Size
|
Total Sample Size="294"
Sample Size from India="294" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/08/2020 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Brief Summary
|
The study is a 12 month month, prospective, unblinded, parallel cluster randomized controlled trial. The study will impart a 20 hour training (pertaining to type 2 diabetes & complications) to the ASHA workers across 8-10 Basti dawakhanas & Primary health centres across Hyderabad & Rangareddy districts of Telangana. The primary outcome will measure the change in competence of these ASHA workers in relation to Type 2 Diabetes and its complications using a modification of of Diabetes Knowledge Test 2 questionnaire for the local conditions along with a practical test of skills by experts. Baseline and post training scores will be assessed to compare the change in competence levels if any. The secondary outcome will look at a one year follow up of the competency levels of the study participants. |
