Tuberculosis
Conditions
Keywords
Tuberculosis, Armenia, Clinical trial, Directly Observed Therapy (DOT), Self-administered drug intake
Brief summary
Randomized trial tests effectiveness of self-administered drug intake by empowered TB patients - supervised by a trained family member and supported by medical counseling and reminders - to improve treatment adherence and treatment success rates, and thereby forestall TB and MDR-TB epidemics.
Detailed description
The innovative treatment approach integrates several educational, technological, and social evidence-based components. The aim of this study is to pilot the innovative approach for drug-sensitive TB patients during the outpatient phase of tuberculosis treatment. To test the effectiveness of the innovative approach (intervention) a randomized controlled trial with two arms will be conducted. The intervention arm will include drug-sensitive tuberculosis patients that are treated according to the innovative approach, which includes self-administered drug intake supervised by a family member, TB patient and family member training (including distribution of a leaflet about TB) and psychological counseling, reminder text messages to TB patients, and reminder phone call to TB patient family members. The control arm will include drug-sensitive tuberculosis patients that receive the regular Directly Observed Therapy recommended by the World Health Organization.
Interventions
BEHAVIORALTB knowledge and socio-psychological counseling session
TB patients and their family members will participate in one-day counseling session provided by a trained psychologist and a TB nurse
OTHERSMS text messages
TB patients will receive SMS text messages every morning (except Sunday) during the whole ambulatory TB treatment phase as a reminder for taking the TB medication prescribed and provided by the TB physician
OTHERphone calls
Family members of the TB patients will receive phone calls every evening (except Sunday) during the whole ambulatory TB treatment phase to assure that the patient takes the medication prescribed and provided by the TB physician and to collect information on treatment adherence and possible side effects.
BEHAVIORALSelf-administered drug intake strategy
Once a week TB patients will receive the TB medication from their local outpatient TB centers and will use the medication every day (six days a week, except Sunday according to the TB treatment protocol) at home under supervision of a family member in charge.
BEHAVIORALEducational leaflet
Educational leaflet containing information on TB infection; infection control measures; importance of TB treatment adherence and family support will be provided to all TB patients at the end of the counselling session
Sponsors
Grand Challenges Canada
National Tuberculosis Control Center, Ministry of Health, Republic of Armenia
Varduhi Petrosyan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of drug-sensitive TB * Age 18 years old and above * Understanding and reading in Armenian * Completion of the intensive treatment phase
Exclusion criteria
* Involvement in the Home Based TB Treatment Program of the National TB Control Office
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TB Treatment Success Rates Defined by the World Health Organization (WHO) | Patients were followed for the duration of ambulatory phase of treatment, an average of 4.2 months | The sum of cured (TB patients with bacteriologically confirmed TB at the beginning of treatment who were smear- or culture-negative in the last month of treatment and on at least one previous occasion) and treatment completed (TB patients who completed treatment without evidence of failure but with no record to show that sputum smear or culture results in the last month of treatment and on at least one previous occasion were negative,either because tests were not done or because results are unavailable). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stigma Level Towards TB Patients | At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment) | Stigma level towards TB patients will be measured by surveys |
| Family Support Towards TB Patients | At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment) | Change in family support towards TB patients will be measured by surveys |
| Knowledge About TB Infection | At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment) | Knowledge about TB infection will be measured by surveys |
| Depression Status of TB Patients | At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment) | Depression status of TB patients will be measured by surveys |
| Quality of Life of TB Patients | At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment) | Quality of life of TB patients will be measured by surveys |
| TB Treatment Adherence | At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment) | TB treatment adherence will be measured by surveys |
Countries
Armenia
Participant flow
Recruitment details
Between 12 March and 26 December 2014, we identified and contacted eligible TB patients from the intervention TB out-patient clinics as well as the control TB out-patient clinics.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm The intervention included the following components: self-administered drug intake strategy, TB knowledge and socio-psychological counseling session, SMS text messages, phone calls, educational leaflet. | 194 |
| Control Arm Patients included in the control arm received traditional - clinical Directly Observed Therapy (DOT) as recommended by WHO. | 198 |
| Total | 392 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Age, Continuous | 45.9 years STANDARD_DEVIATION 15.9 | 47.8 years STANDARD_DEVIATION 14.9 | 46.8 years STANDARD_DEVIATION 15.4 |
| Sex: Female, Male Female | 39 Participants | 48 Participants | 87 Participants |
| Sex: Female, Male Male | 155 Participants | 150 Participants | 305 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 194 | 0 / 198 |
| serious Total, serious adverse events | 3 / 194 | 3 / 198 |
Outcome results
Primary
TB Treatment Success Rates Defined by the World Health Organization (WHO)
The sum of cured (TB patients with bacteriologically confirmed TB at the beginning of treatment who were smear- or culture-negative in the last month of treatment and on at least one previous occasion) and treatment completed (TB patients who completed treatment without evidence of failure but with no record to show that sputum smear or culture results in the last month of treatment and on at least one previous occasion were negative,either because tests were not done or because results are unavailable).
Time frame: Patients were followed for the duration of ambulatory phase of treatment, an average of 4.2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | TB Treatment Success Rates Defined by the World Health Organization (WHO) | 184 Participants |
| Intervention Arm | TB Treatment Success Rates Defined by the World Health Organization (WHO) | 176 Participants |
Secondary
Depression Status of TB Patients
Depression status of TB patients will be measured by surveys
Time frame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
Secondary
Family Support Towards TB Patients
Change in family support towards TB patients will be measured by surveys
Time frame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
Secondary
Knowledge About TB Infection
Knowledge about TB infection will be measured by surveys
Time frame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
Secondary
Quality of Life of TB Patients
Quality of life of TB patients will be measured by surveys
Time frame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
Secondary
Stigma Level Towards TB Patients
Stigma level towards TB patients will be measured by surveys
Time frame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
Secondary
TB Treatment Adherence
TB treatment adherence will be measured by surveys
Time frame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)