Quality of LifeNCT03125668
Impact of Telephone Follow-up in Patient's Health-related Quality of Life That Use Warfarin
A study testing Educational Program, Telephone follow-up and Face to face counseling in people with Quality of Life and Warfarin, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to test an educational program with telephone follow-up to improve health-related quality of life (HRQoL), treatment adherence, and reduce anxiety and depression symptoms in patients who are starting oral anticoagulants (OA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Warfarin, Health Education
- What is being tested?
- Educational Program, Telephone follow-up and Face to face counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2015to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years;
- Both genders;
- To start the use of Warfarin for the first time during the current hospitalization;
- To have a phone.
Who cannot join
- To start the Oral Anticoagulation Therapy with another oral anticoagulant;
- To start the Warfarin for surgical procedures;
- To have visual or hearing impairments;
- Don't have cognitive conditions* to answer the questions of data collection instruments (measured by adapted questions from Pfiefer (1975);
- To have a cancer diagnosis.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, 14040902
About this study
Official title: Impact of Telephone Follow-up in Patient's Health-related Quality of Life During the First Six Months of Warfarin Use: Randomized Clinical Trial
The purpose of this study is to test an educational program with telephone follow-up to improve health-related quality of life (HRQoL), treatment adherence, and reduce anxiety and depression symptoms in patients who are starting oral anticoagulants (OA).
Read the detailed description
Randomized controlled trial (RCT) at two Brazilian public hospitals, one in Ribeirão Preto and another one in Américo Brasiliense, state of São Paulo, Brazil.
Both groups will receive the educational program (Power Point®Slides, booklets and orientation) at the hospitalization. After the hospital discharge, the intervention group will receive the telephone follow-up (five calls for six months: 1st call in one week and the others calls month by month until six months) and two face to face counseling (1st meeting in three months and the 2nd meeting in six months). The control group just receive the same face to face counseling (1st meeting in three months and the 2nd meeting in six months) after the hospital discharge.
The educational program consist in information about the use of Warfarin and approach the specific topics in Power Point®Slides: Physiology: Definition of oral anticoagulants, mechanisms of action and clinical indication; Medication: Dose, time, storage and duration of therapy; Monitoring: Meaning of International Normalized Ratio (INR) , collection period and doctor's appointments; Other medications: Drug interactions and those considered "natural"; Feeding: Eating foods rich in K vitamin and fats; Alcoholic beverage: Care about alcohol , and if it occurs, does not stop the Oral Anticoagulants; Gestation: Necessity to start IV anticoagulants; Activities: In physical, domestic or work activities to use protective measures; Health treatment: Warn about OA to other professional and take the card of INR values; Travels: On trips take the OA and be programmed to the realization of INR out of their units; Signs /Symptoms: Report underdose (thrombus formation) and overdose (bleeding), seek health care.
After the orientations with Power Point®Slides, the patients receive one booklet with the same informations and the researcher answer any questions that patients have about the anticoagulation therapy.
In this moment (at hospitalization) the researcher also collects the data about symptoms of anxiety and depression using the validated questionnaire.
During the telephone calls the researcher talk with the patient about the topics that were approach in the educational intervention and motivate the patient to follow the recommendations for they have a successful treatment.
In the face to face counseling (three and six months after hospital discharge) the researcher collect the data about anxiety and depression again, health-related quality of life and adverse events related to oral anticoagulation therapy.
- Conditions
- Quality of Life, Warfarin, Health Education, Patient Compliance
- Being tested
- Educational Program, Telephone follow-up, Face to face counseling
- Medical subject headings
- Health Education, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational ProgramBehavioural
At the hospitalization, patients receive the educational program with Power Point®Slides, booklets and orientation about the use of warfarin.
Telephone follow-upBehavioural
After hospital discharge they receive a telephone follow-up (five calls for six months: 1st call in one week and the others calls month by month until six months).
During the telephone calls the researcher talk with the patient about the topics that were approach in the educational intervention and motivate the patient to follow the recommendations for they have a successful treatment.
Face to face counselingBehavioural
They receive two face to face counseling (1st meeting in three months and the 2nd meeting in six months after hospital discharge). In the face to face counseling the researcher collect the data about anxiety and depression again, health-related quality of life and adverse events related to oral anticoagulation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | At the hospitalization, patients receive the educational program (Power Point®Slides, booklets and orientation) about the use of warfarin. After hospital discharge they receive a telephone follow-up (five calls) and two Face to face counseling. Receives: Behavioral: Educational Program; Behavioral: Telephone follow-up; Behavioral: Face to face counseling |
| Control Group | Active comparator | At the hospitalization, patients receive the educational program (Power Point®Slides, booklets and orientation) about the use of warfarin. After hospital discharge they receive two face to face counseling. Receives: Behavioral: Educational Program; Behavioral: Face to face counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health-Related Quality of Life
The Duke Anticoagulation Satisfaction Scale (DASS) was developed by Samsa et al. (2004) and validated for the Brazilian population by Pelegrino et al. (2011). The scale have 25 items divided in three domains: Limitation (9 items); Hassles and burdens (8 items); Psychological Impacts (8 items). All items have seven response categories: "not at all", "a little", "somewhat", "moderately", "quite a bit", "a lot", and "very much". Possible range: 25 to 175 and lower scores, indicated better Health-Related Quality of Life.
Measured: Three and six months after hospital discharge
Secondary outcomes (3)
Change in Symptoms of Anxiety and Depression
The questionnaire "Hospital Anxiety and Depression Scale (HADS)" was developed by Zigmond and Snaith (1983) and validated and adapted to Portuguese by Botega et al. (1995). The HADS contains 14 multiple choice questions, divided into two subscales: anxiety and depression (composed of seven items each).This questionnaire will be used to collect the data at baseline and at six months.
Measured: At baseline, Three and six months after hospital discharge.
Adherence
Patient adherence to oral anticoagulation therapy will be assessed by the INR (International Normalized Ratio) stability that will be calculated by the percentage of time patients remain within the measurement range using the number of INRs within the therapeutic range, divided by the number of INRs collected.
Measured: INR values during the six months follow-up
Assessment and frequency of adverse events related to Warfarin
Three questions developed by the authors about adverse events related to Warfarin.
Measured: Three and six months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start1 Oct 2015
- Primary completion30 May 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafaela de Oliveira Manzato, University of Sao Paulo
- Investigators
- Rosana S Dantas, PhD, Study chair, University of São Paulo at Ribeirão Preto College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125668
- Sponsor's protocol ID
- 38736914.1.0000.5393
- Status last verified
- Mar 2020
- First submitted
- 22 Feb 2017
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Telephone Follow-up in Patient's Health-related Quality of Life During the First Six Months of Warfarin Use: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03125668
- Acronym / sponsor ID
- 38736914.1.0000.5393
- Conditions
- Quality of Life, Warfarin, Health Education, Patient Compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test an educational program with telephone follow-up to improve health-related quality of life (HRQoL), treatment adherence, and reduce anxiety and depression symptoms in patients who are starting oral anticoagulants (OA).
Detailed description
Randomized controlled trial (RCT) at two Brazilian public hospitals, one in Ribeirão Preto and another one in Américo Brasiliense, state of São Paulo, Brazil.
Both groups will receive the educational program (Power Point®Slides, booklets and orientation) at the hospitalization. After the hospital discharge, the intervention group will receive the telephone follow-up (five calls for six months: 1st call in one week and the others calls month by month until six months) and two face to face counseling (1st meeting in three months and the 2nd meeting in six months). The control group just receive the same face to face counseling (1st meeting in three months and the 2nd meeting in six months) after the hospital discharge.
The educational program consist in information about the use of Warfarin and approach the specific topics in Power Point®Slides: Physiology: Definition of oral anticoagulants, mechanisms of action and clinical indication; Medication: Dose, time, storage and duration of therapy; Monitoring: Meaning of International Normalized Ratio (INR) , collection period and doctor's appointments; Other medications: Drug interactions and those considered "natural"; Feeding: Eating foods rich in K vitamin and fats; Alcoholic beverage: Care about alcohol , and if it occurs, does not stop the Oral Anticoagulants; Gestation: Necessity to start IV anticoagulants; Activities: In physical, domestic or work activities to use protective measures; Health treatment: Warn about OA to other professional and take the card of INR values; Travels: On trips take the OA and be programmed to the realization of INR out of their units; Signs /Symptoms: Report underdose (thrombus formation) and overdose (bleeding), seek health care.
After the orientations with Power Point®Slides, the patients receive one booklet with the same informations and the researcher answer any questions that patients have about the anticoagulation therapy.
In this moment (at hospitalization) the researcher also collects the data about symptoms of anxiety and depression using the validated questionnaire.
During the telephone calls the researcher talk with the patient about the topics that were approach in the educational intervention and motivate the patient to follow the recommendations for they have a successful treatment.
In the face to face counseling (three and six months after hospital discharge) the researcher collect the data about anxiety and depression again, health-related quality of life and adverse events related to oral anticoagulation therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Educational Program, Behavioral: Telephone follow-up, Behavioral: Face to face counselingAt the hospitalization, patients receive the educational program (Power Point®Slides, booklets and orientation) about the use of warfarin. After hospital discharge they receive a telephone follow-up (five calls) and two Face to face counseling. |
| Control Group | Active comparator | Behavioral: Educational Program, Behavioral: Face to face counselingAt the hospitalization, patients receive the educational program (Power Point®Slides, booklets and orientation) about the use of warfarin. After hospital discharge they receive two face to face counseling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years;
- Both genders;
- To start the use of Warfarin for the first time during the current hospitalization;
- To have a phone.
Key exclusion criteria (5 listed)
- To start the Oral Anticoagulation Therapy with another oral anticoagulant;
- To start the Warfarin for surgical procedures;
- To have visual or hearing impairments;
- Don't have cognitive conditions* to answer the questions of data collection instruments (measured by adapted questions from Pfiefer (1975);
- To have a cancer diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational ProgramAt the hospitalization, patients receive the educational program with Power Point®Slides, booklets and orientation about the use of warfarin. | Behavioural | Control Group, Intervention Group |
| Telephone follow-upAfter hospital discharge they receive a telephone follow-up (five calls for six months: 1st call in one week and the others calls month by month until six months). During the telephone calls the researcher talk with the patient about the topics that were approach in the educational intervention and motivate the patient to follow the recommendations for they have a successful treatment. | Behavioural | Intervention Group |
| Face to face counselingThey receive two face to face counseling (1st meeting in three months and the 2nd meeting in six months after hospital discharge). In the face to face counseling the researcher collect the data about anxiety and depression again, health-related quality of life and adverse events related to oral anticoagulation therapy. | Behavioural | Control Group, Intervention Group |
Primary outcome
Change in Health-Related Quality of Life
Time frame: Three and six months after hospital discharge
The Duke Anticoagulation Satisfaction Scale (DASS) was developed by Samsa et al. (2004) and validated for the Brazilian population by Pelegrino et al. (2011). The scale have 25 items divided in three domains: Limitation (9 items); Hassles and burdens (8 items); Psychological Impacts (8 items). All items have seven response categories: "not at all", "a little", "somewhat", "moderately", "quite a bit", "a lot", and "very much". Possible range: 25 to 175 and lower scores, indicated better Health-Related Quality of Life.
3 secondary outcomes
Change in Symptoms of Anxiety and Depression
Time frame: At baseline, Three and six months after hospital discharge.
Adherence
Time frame: INR values during the six months follow-up
Assessment and frequency of adverse events related to Warfarin
Time frame: Three and six months after hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Quality of Life
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosana S Dantas, PhD study chair
University of São Paulo at Ribeirão Preto College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Program, Telephone follow-up and Face to face counseling in people with Quality of Life and Warfarin, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health-Related Quality of Life (time frame: Three and six months after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.