| CTRI Number |
CTRI/2015/01/005415 [Registered on: 15/01/2015] Trial Registered Retrospectively |
| Last Modified On: |
14/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Psychological] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Self management for patients with type 2 diabetes mellitus |
|
Scientific Title of Study
|
The Development and Feasibility of a Self Management intervention in Type 2 Diabetes Mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anisha Mary Abraham |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology, NIMHANS, Hosur Road, Bangalore
Department of Clinical Psychology, NIMHANS, Hosur Road, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
919886176879 |
| Fax |
918026564830 |
| Email |
anishamaryabraham@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Paulomi M Sudhir |
| Designation |
Additional Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology, NIMHANS, Hosur Road, Bangalore
Department of Clinical Psychology, NIMHANS, Hosur Road, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
919886176879 |
| Fax |
918026564830 |
| Email |
paulomi.sudhir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anisha Mary Abraham |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology, NIMHANS, Hosur Road, Bangalore
Department of Clinical Psychology, NIMHANS, Hosur Road, Bangalore
KARNATAKA
560029
India |
| Phone |
919886176879 |
| Fax |
918026564830 |
| Email |
anishamaryabraham@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIMHANS |
| Address |
National Institute of Mental Health and Neurosciences, Hosur Road Bangalore |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anisha Abraham |
St Johns medical college |
Department of Endocrinology, Outpatient Block, St Johns Medical college and hospital, Bangalore 560034
Bangalore
KARNATAKA |
919902763930
anishamaryabraham@gmail.com |
| Dr Ganapathi Bantwal |
St.Johns hospital |
Dr. Ganapathi Bantwal, Professor and Head
Department of Endorcrinology
St.Johns hospital,Medical College,Sarjapur Road
Bangalore
KARNATAKA |
9448067318
mallyaganapathi@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| NIMHANS Institute Ethics Committee |
Approved |
| St. Johns Institute Ethical Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
self management intervention |
Psychological therapy comprising of 4 sessions including counseling for coping skills, relaxation, problem solving. The duration of each session was 30-45 minutes and the entire program was carried out over 8 weeks after which post assessment was done, and later follow up at 3 months. |
| Intervention |
Treatment as usual |
Medication and education
Patients were seen at baseline and subsequently at 8 weeks after baseline and after 3 months for a reassessment. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Primary diagnosis of type 2 Diabetes Mellitus
2. Age between 30- 65 years
3. Duration of illness of at least 1 year
4. Working knowledge of English/ Hindi/ Kannada
5. Patients with HbA1c in the range of 7.5 to 10
|
|
| ExclusionCriteria |
| Details |
Comorbid psychiatric condition in the patient
Comorbid substance use amounting to dependence
Cases of gestational diabetes, Cases of drug induced diabetes Known cases of myocardial infarction and cerebrovascular illness
The presence of significant microvascular complications such as amputations, end stage renal disease, and retinopathy
Participants who have received structured psychological intervention in the last one year
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| self care, metabolic control, quality of life |
baseline, post and 3 month followup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| illness perception, mood |
baseline, post and 3 month followup |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/06/2013 |
| Date of Study Completion (India) |
02/02/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="3" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Abraham A Sudhir P Mariamma P Bantwal G (2020). Efficacy of a Brief Self-management Intervention in Type 2 Diabetes Mellitus A Randomized Controlled Trial from India. Indian Journal of Psychological Medicine DOI 10.1177/0253717620932250 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The aim of the study is to develop a diabetes self management intervention and examine its feasibility and impact on improving self care, metabolic control and quality of life in patients with type 2 Diabetes Mellitus. A coping skills intervention, focusing on addressing self care and emotional issues in diabetes was designed. The study employs a randomized control design in which the self management intervention be carried out on a sample of 60 patients. Patients will be recruited from a general hospital setting and randomized to either an intervention group or a treatment as usual group. Assessments on illness perceptions, mood, self care, metabolic control and diabetes specific quality of life will be made at baseline, post therapy and 3 months follow-up |