| CTRI Number |
CTRI/2014/05/004595 [Registered on: 13/05/2014] Trial Registered Retrospectively |
| Last Modified On: |
02/05/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Behavioral
Other (Specify) [Teaching the patients on self care ] |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
Effectiveness of self care manual on knowledge on self care, Attitude, Adherence to Anti Retroviral therapy (ART), Anxiety, Quality of life (QOL), and Practices in home care management of persons living with HIV infection (PLHIV).
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Scientific Title of Study
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Effectiveness of self care intervention guidelines on knowledge on self care, Attitude, Compliance to Anti-retroviral therapy (ART), Anxiety, Quality of life (QOL), and Practices in home care management of persons living with HIV infection (PLHIV).
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| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Balasaraswathi Seetharaman |
| Designation |
Professor in Nursing |
| Affiliation |
Christian Medical College, Vellore- 632004t |
| Address |
College of Nursing, C.M.C., Vellore.
Phone-College of Nursing : 0416307-7010
Cell : 9894376620
59- Katpadi Road, Thottapalayam,Vellore-632004.
Phone:Residence- 2212160
Vellore
TAMIL NADU
632004
India |
| Phone |
9894376620 |
| Fax |
04162223362 |
| Email |
balasraman@cmcvellore.ac.in |
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Details of Contact Person
Scientific Query
|
| Name |
DrPremila Lee |
| Designation |
Professor in Nursing, |
| Affiliation |
Christian Medical College, Vellore- 632004 |
| Address |
College of Nursing, C.M.C., Vellore.
Phone-College of Nursing : 0416307-7002
Medical College campus,CMC, Bagayam, Vellore.632 002.
Vellore
TAMIL NADU
632004
India |
| Phone |
9994830098 |
| Fax |
04162223362 |
| Email |
premilalee@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
Balasaraswathi Seetharaman |
| Designation |
Professor in Nursing |
| Affiliation |
Christian Medical College, Vellore- 632004t |
| Address |
College of Nursing, C.M.C., Vellore.
Phone-College of Nursing : 0416307-7010
Cell : 9894376620
59- Katpadi Road, Thottapalayam,Vellore-632004.
Phone:Residence- 2212160
Vellore
TAMIL NADU
632004
India |
| Phone |
9894376620 |
| Fax |
04162223362 |
| Email |
balasraman@cmcvellore.ac.in |
|
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Source of Monetary or Material Support
|
| Fluid Research Grant- CMC |
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Primary Sponsor
|
| Name |
Fluid research grant internalCMC |
| Address |
Christian Medical College, Vellore-632004 |
| Type of Sponsor |
Research institution and hospital |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAnand Zachariah |
Actfid ART clinic |
Christian Medical College, Vellore- 632004
Vellore
TAMIL NADU |
9486939504
2232035
zachariah@cmcvellore.ac.in |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board for ethics |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Patients with HIV/AIDS who are on Anti Retroviral Therapy., |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Self care intervention guidelines is the intervention. It is the manual prepared and validated by the experts to be used for teaching the subjects on self care. |
On the day of data collection, the subjects who meet the inclusion criteria will be identified by reviewing the chart.PLHIV will be recruited for the study by systematic random sampling technique.
Permuted block randomization will be used to allocate subjects into experimental and control groups.
Data collection will be done at three time points for both experimental and control groups. After allocation of subjects into study groups, rapport will be established by the investigator and written consent will be obtained after explaining about the purpose and methodology of the study. Interview technique will be used to collect data.
The first assessment (pre-test) will be done as soon as the subject is selected for both the groups which include socio-demographic and clinical data and various tools will be used to measure the outcome variables. The second time point for collecting data is 4-6weeks after the first assessment. The third assessment will be at 12-14 weeks.
Pretest data will be collected on knowledge on self care, attitude, anxiety, compliance to ART, quality of life and practices on home care management of minor illnesses by the investigator using the interview technique.
Intervention:
After the pretest, intervention will be administered by the investigator privately & individually with the help of appropriate audio visual aids. Each subject will be met individually and one to one teaching will be given. Intervention will be administered by the investigator in one session & the planned duration is 45 minutes to one hour. Then, each subject will be given a copy of the SCIG.
Post-test I:
Post test-I will be done at 4-6 weeks which will be followed by reinforcement.
Reinforcement
During first follow-up, the subjects belonging to the experimental group will be reviewed the content of SCIG and their doubts regarding self care management will be clarified.
Post-test II:
At 12-14 weeks second post-test will be done. Privacy & confidentiality will be maintained throughout the data collection procedure.
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| Comparator Agent |
Standard care:
After the pre-test assessment, the subjects in the control group will receive the standard care. Standard care is the usual care they receive from the health care personnel at ART clinic during their monthly visit. |
Pretest data will be collected on knowledge on self care, attitude, anxiety, compliance to ART, quality of life and practices on home care management of minor illnesses by the investigator using the interview technique.
Standard care:
After the pre-test assessment, the subjects in the control group will receive the standard care. Standard care is the usual care they receive from the health care personnel at ART clinic during their monthly visit.
Post-test I:
Post test-I will be done at 4-6 weeks.
Post-test II:
At 12-14 weeks second post-test will be done.
After the data collection, control group subjects also will be given education and a copy of the self care intervention guidelines. Privacy & confidentiality will be maintained throughout the data collection procedure.
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
PLHIV who are;
• able to speak and read Tamil or English
• on ART
• between the age of 18 and 65 irrespective of their clinical stage
|
|
| ExclusionCriteria |
| Details |
PLHIV who are;
• on anxiolytic drugs
• having psychiatric illness. (Diagnosed by the Psychiatrist)
• unwilling to give written consent
• with co-existing severe, chronic debilitating diseases such as COPD, cancer, renal disease.
• with dementia
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Method of Generating Random Sequence
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Permuted block randomization, fixed |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
o Improvement in knowledge on self care, attitude, compliance to ART, quality of life,and practices in home care management of minor illnesses.
o Reduction in anxiety
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At 4th week and 12th week after the intervention. |
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Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
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Target Sample Size
|
Total Sample Size="148"
Sample Size from India="148"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
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Date of First Enrollment (India)
|
07/03/2014 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
|
"None Yet" |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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Objectives and aims of study o To develop and validate self care intervention guidelines for Persons Living with HIV Infection (PLHIV) on ART. o To assess the knowledge on self care, attitude, compliance to ART, anxiety, Quality of Life (QOL) and practices in home care management of PLHIV before and after standard care and self care intervention guidelines. o To assess the effectiveness of self care intervention guidelines on the knowledge on self care, attitude, compliance to ART, anxiety, QOL, and practices in home care management of PLHIV. o To determine the relationship between knowledge on self care, attitude, compliance to ART, anxiety, QOL, & practices in home care management of PLHIV o To determine the association between the pretest scores of knowledge on self care, attitude, compliance to ART, anxiety, QOL, & practices in home care management of PLHIV with their socio-demographic and clinical variables. Research Hypotheses H1- There will be a significant increase in the knowledge on self care, attitude, and practices in home care management of PLHIV with Self Care Intervention Guidelines (SCIG) than the PLHIV without SCIG as measured by questionnaire, likert scale & checklist. H2-There will be a significant reduction in anxiety, improvement in compliance to ART, & QOL of PLHIV with SCIG than the PLHIV without SCIG as measured by State Trait Anxiety Inventory (STAI) Scale, Morisky Medication Adherence Scale ( MMAS), and patient recall & pill count and World Health Organization Quality Of Life BREF (WHOQOL-BREF) scale respectively. H3- knowledge on self care, attitude, compliance to ART, anxiety, QOL, has significant relationship with the practices in home care management of PLHIV. H4- There will be a significant association between the pretest scores of knowledge on self care, attitude, compliance to ART, anxiety, QOL, & practices in home care management of PLHIV and their selected socio-demographic and clinical variables. This study will be done at ART Clinic, CMC, Vellore, to develop and assess the effectiveness of Self Care Intervention Guidelines (SCIG) on knowledge on self care, attitude, anxiety, compliance to ART, QOL and practices in home care management of PLHIV who are taking ART. The targeted sample size is 148 i.e.74 in each group. Systematic random sampling technique will be used to choose the eligible subjects for the study. Block randomization will be done to allocate subjects into experimental and control group. The control group subjects will receive the standard care and SCIG will be administered as intervention to subjects in the experimental group. For subjects in both the groups, data will be collected at 3 time points i.e. pretest, post-test I at 4-6th week (2nd month) and post-test II at 12-14 weeks (4th month). Data will be analyzed using SPSS version 20. |