Heart FailureTOMASNCT03549169
Decision Making for the Management the Symptoms in Adults of Heart Failure
A study testing TOMAS and Regular attention in people with Heart Failure, run by Universidad Nacional de Colombia at 1 site in Colombia.
Trial summary
Introduction. Heart failure (HF) is the most prevailing chronic illness in the world. In Colombia, high morbidity and mortality rates because of HF are registered, as well as a significant burden of symptoms, frequent hospitalizations, poor quality of life, significant consumption of health resources and early… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- TOMAS and Regular attention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteColombia
- Study dates
- 4 Sep 2017to 30 Mar 2019
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (over 18 years of age).
- More than two months of having been diagnosed.
- Conserves cognitive state.
- Absence or low co-morbidity.
Who cannot join
- Confirmed diagnose of acute HF.
- Confirmed diagnose of advanced HF.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decision Making for the Management for the Symptoms in Adults of Heart Failure: Randomized Clinical Trial
Introduction. Heart failure (HF) is the most prevailing chronic illness in the world. In Colombia, high morbidity and mortality rates because of HF are registered, as well as a significant burden of symptoms, frequent hospitalizations, poor quality of life, significant consumption of health resources and early mortality. It is necessary to propose novel strategies that can change the current picture.
Objective: determine the efficacy of an intervention centered in decision taking for the handling of symptoms in adults with HF who live in the department of Cordoba, Colombia.
Read more
Hypothesis
Primary hypothesis: the intervention Decision taking for the handling of symptoms in adults with HF: 1) Increases self-care.
Secondary hypothesis: 1) reduces clinical events: emergency care and hospitalizations, 3) Improves quality of life related to health.
Read the detailed description
Intervention: The theoretic approach of the Theory of the Specific Situation Self-care in HF was used for the design of the intervention.
Supplier/dosage/duration. The intervention was given by the researcher (nurse trained in the intervention protocol) in three doses, each contact lasts 60 minutes. Frequency: sessions are given once a week during a one-month period (duration). Nurse controls are implemented after the intervention after one month and three months. There is also telephonic accompaniment on application of the participant.
Delivery method/environment. Verbal: Individual face to face. Printed educational written material type brochure, outpatient clinic of a health institution.
Methodology
Participants: inclusion criteria: adults (over the age of 18 years), more than two months of having been diagnosed; functional New York Heart Association (NYHA) Class II - III, left ventricular ejection fraction reduced (<40%). Cognitive state conservation (Lobo cognitive mini exam - MEC-35). Absence or low co-morbidity (Charlson index). Exclusion criteria: acute HF, advanced HF
Sample: The study was designed to have a 90% output, (alpha = 0.05), an expected difference of 0.5 in the outcome score of the management and maintenance evaluation in both groups, a standard deviation of outcome scores of 1.0, a correlation average between the first and the second evaluation of 0.2 and a rate of wear of 20%. Therefore, the required final sample size was 124 (62 per group - theoretic sample).
Pilot study: 176 adults with HF were recruited. 114 entered the study. 62 were excluded (did not meet the inclusion criteria (n=39), did not want to participate (=14), other reasons (n=9)).
Randomization. Table of random numbers without repetition. The Participants randomly assigned to the control group CG (n=57) received the standard attention, including standard education given by attention providers, and the ones assigned to the intervention group IG (n=57) received the intervention protocol.
Information collection (research assistant). The study registers information in the following time points: beginning (base line), follow up after a month (outpatient appointment), follow up after 3 months (outpatient appointment). The study is classified as simple blind; the research assistant, who is in charge of applying the instrument measuring the effect of the intervention, will remain blinded during the whole study regarding the group assigned to each participant.
Risk control. Compliance with methodological recommendations used to guarantee reliability and validity of the research studies proving a clinic intervention for behavioral changes. A plan is being contemplated that includes goals and strategies to monitor and counter possible threats to internal and external validity.
Ethical aspects. Compliance with universal ethical principles for research on humans, according to international ethical guidelines - CIOMS, national regulations, informed consent and deontological Nursing responsibilities in Colombia.
Analysis framework Excel database - SPSS Program analysis
- Descriptive analysis of the total sample and by groups (intervention and control): absolute and relative frequency distributions; median and standard deviation.
- Data normality analysis: Kolmogorov-Smirnov test Statistical analysis for independent samples a) difference of proportions: X2, b) difference of means: t for student, c) difference of medians: U test of Mann - Whitney. In all cases a statistic significance will be assumed if the value p < 0.05.
- Intrasubject and intergroup analysis: ANOVA with repeated measurements.
- Hypothesis proof: W of Mauchly test. When the sphericity premise is fulfilled, test F will be used.
- Analysis of possible confusion and/or interaction effect.
- Stratified analysis: X2 of Mantel-Haenszel (M-H),
- Logistic regression analysis. Stepwise method. Minimum change % considered as favorable (≥20=1, ≤19=0).
- Analysis of the magnitude of the intervention's effect. Improvement of at least 20% of the score on the scale, with the analysis principle of the intention of trying. The absolute increase in benefit and the necessary number for treatment (NNT) will be calculated afterwards.
- Conditions
- Heart Failure
- Being tested
- TOMAS, Regular attention
- Keywords
- Intervention, Heart Failure, Symptoms management, Selft-care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOMASBehavioural
Intervention focused on decision making for the management of symptoms aimed at adults with heart failure.
Regular attentionBehavioural
Regular attention focused on education for therapeutic adherence
| Study group | Role | What they receive |
|---|---|---|
| TOMAS | Experimental | Intervention centered on taking decisions for management of symptoms in adults with Heart Failure. Includes 3 doses (self-care maintenance, symptom perception and symptom management) and 4 strategies are developed: knowledge of the situation, experience and abilities in decision taking and compatibility with personal values. Receives: Behavioral: TOMAS |
| Standard or regular attention | Other | Regular attention is centered on education for therapeutic adherence Receives: Behavioral: Regular attention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-care of heart failure index
The Self-Care of Heart Failure Index is a measure of self-care defined as a naturalistic decision making process involving the choice of behaviors that maintain physiologic stability and the response to symptoms when they occur. A score of ≥70 can be used as the cut-point to judge self-care adequacy.
We strongly discourage users from calculating a total, combined SCHFI score. Instead, the data will be far more useful if the scales (maintenance, management, confidence) are used individually. Each scale is standardized to a score of 100.
Use the following formula to compute a standardized:
Maintenance: (sum of Section A items - 10) * 3.333 Management: (sum of Section B items - 4) * 5 Confidence: (sum of Section C items - 6) * 5.56
Measured: Change from baseline self-care for heart failure index at 3 months
Secondary outcomes (2)
Results in health
Emergency admissions, hospitalization, death by heart failure
Measured: Change from baseline results in health at 3 months
Quality of life related to health
The Minnesota Living with Heart Failure Questionnaire is one of the most widely used health-related quality of life questionnaires for patients with heart failure (HF). It provides scores for two dimensions, physical and emotional, and a total score. Comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on quality of life related to health, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL), as well as scores for two dimensions, physical (8 items, range 0-40) and emotional (5 items, range 0-25). The other eight items (of the totalof 21) are only considered for the calculation of the total score.
The Minnesota Living with Heart Failure Questionnaire has been translated into and validated in Spanish - Colombia.
Measured: Change from baselineQuality of life related to health punctuation at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start4 Sep 2017
- Primary completion31 Dec 2018
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Model description
- The participants are assigned to two groups during the duration of the study. A group receives the standard attention and the intervention protocol and the other group only the standard attention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Colombia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EUGENIA HERRERA GUERRA, NURSE, Principal investigator, Universidad Nacional de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549169
- Sponsor's protocol ID
- UNColombia
- Acronym
- TOMAS
- Status last verified
- Jun 2021
- First submitted
- 24 Mar 2018
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication of articles derived from the main study
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Making for the Management for the Symptoms in Adults of Heart Failure: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03549169
- Acronym / sponsor ID
- TOMAS / UNColombia
- Conditions
- Heart Failure
- Keywords
- Intervention, Heart Failure, Symptoms management, Selft-care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Universidad Nacional de ColombiaUniversity, hospital or other
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 7 Jun 2018 (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.
Introduction. Heart failure (HF) is the most prevailing chronic illness in the world. In Colombia, high morbidity and mortality rates because of HF are registered, as well as a significant burden of symptoms, frequent hospitalizations, poor quality of life, significant consumption of health resources and early mortality. It is necessary to propose novel strategies that can change the current picture.
Objective: determine the efficacy of an intervention centered in decision taking for the handling of symptoms in adults with HF who live in the department of Cordoba, Colombia.
Hypothesis
Primary hypothesis: the intervention Decision taking for the handling of symptoms in adults with HF: 1) Increases self-care.
Secondary hypothesis: 1) reduces clinical events: emergency care and hospitalizations, 3) Improves quality of life related to health.
Detailed description
Intervention: The theoretic approach of the Theory of the Specific Situation Self-care in HF was used for the design of the intervention.
Supplier/dosage/duration. The intervention was given by the researcher (nurse trained in the intervention protocol) in three doses, each contact lasts 60 minutes. Frequency: sessions are given once a week during a one-month period (duration). Nurse controls are implemented after the intervention after one month and three months. There is also telephonic accompaniment on application of the participant.
Delivery method/environment. Verbal: Individual face to face. Printed educational written material type brochure, outpatient clinic of a health institution.
Methodology
Participants: inclusion criteria: adults (over the age of 18 years), more than two months of having been diagnosed; functional New York Heart Association (NYHA) Class II - III, left ventricular ejection fraction reduced (<40%). Cognitive state conservation (Lobo cognitive mini exam - MEC-35). Absence or low co-morbidity (Charlson index). Exclusion criteria: acute HF, advanced HF
Sample: The study was designed to have a 90% output, (alpha = 0.05), an expected difference of 0.5 in the outcome score of the management and maintenance evaluation in both groups, a standard deviation of outcome scores of 1.0, a correlation average between the first and the second evaluation of 0.2 and a rate of wear of 20%. Therefore, the required final sample size was 124 (62 per group - theoretic sample).
Pilot study: 176 adults with HF were recruited. 114 entered the study. 62 were excluded (did not meet the inclusion criteria (n=39), did not want to participate (=14), other reasons (n=9)).
Randomization. Table of random numbers without repetition. The Participants randomly assigned to the control group CG (n=57) received the standard attention, including standard education given by attention providers, and the ones assigned to the intervention group IG (n=57) received the intervention protocol.
Information collection (research assistant). The study registers information in the following time points: beginning (base line), follow up after a month (outpatient appointment), follow up after 3 months (outpatient appointment). The study is classified as simple blind; the research assistant, who is in charge of applying the instrument measuring the effect of the intervention, will remain blinded during the whole study regarding the group assigned to each participant.
Risk control. Compliance with methodological recommendations used to guarantee reliability and validity of the research studies proving a clinic intervention for behavioral changes. A plan is being contemplated that includes goals and strategies to monitor and counter possible threats to internal and external validity.
Ethical aspects. Compliance with universal ethical principles for research on humans, according to international ethical guidelines - CIOMS, national regulations, informed consent and deontological Nursing responsibilities in Colombia.
Analysis framework Excel database - SPSS Program analysis
- Descriptive analysis of the total sample and by groups (intervention and control): absolute and relative frequency distributions; median and standard deviation.
- Data normality analysis: Kolmogorov-Smirnov test Statistical analysis for independent samples a) difference of proportions: X2, b) difference of means: t for student, c) difference of medians: U test of Mann - Whitney. In all cases a statistic significance will be assumed if the value p < 0.05.
- Intrasubject and intergroup analysis: ANOVA with repeated measurements.
- Hypothesis proof: W of Mauchly test. When the sphericity premise is fulfilled, test F will be used.
- Analysis of possible confusion and/or interaction effect.
- Stratified analysis: X2 of Mantel-Haenszel (M-H),
- Logistic regression analysis. Stepwise method. Minimum change % considered as favorable (≥20=1, ≤19=0).
- Analysis of the magnitude of the intervention's effect. Improvement of at least 20% of the score on the scale, with the analysis principle of the intention of trying. The absolute increase in benefit and the necessary number for treatment (NNT) will be calculated afterwards.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The participants are assigned to two groups during the duration of the study. A group receives the standard attention and the intervention protocol and the other group only the standard attention.
| Arm | Type | Receives |
|---|---|---|
| TOMAS | Experimental | Behavioral: TOMASIntervention centered on taking decisions for management of symptoms in adults with Heart Failure. Includes 3 doses (self-care maintenance, symptom perception and symptom management) and 4 strategies are developed: knowledge of the situation, experience and abilities in decision taking and compatibility with personal values. |
| Standard or regular attention | Other | Behavioral: Regular attentionRegular attention is centered on education for therapeutic adherence |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (over 18 years of age).
- More than two months of having been diagnosed.
- Conserves cognitive state.
- Absence or low co-morbidity.
Key exclusion criteria (2 listed)
- Confirmed diagnose of acute HF.
- Confirmed diagnose of advanced HF.
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 |
|---|---|---|
| TOMASIntervention focused on decision making for the management of symptoms aimed at adults with heart failure. | Behavioural | TOMAS |
| Regular attentionRegular attention focused on education for therapeutic adherence | Behavioural | Standard or regular attention |
Primary outcome
Self-care of heart failure index
Time frame: Change from baseline self-care for heart failure index at 3 months
The Self-Care of Heart Failure Index is a measure of self-care defined as a naturalistic decision making process involving the choice of behaviors that maintain physiologic stability and the response to symptoms when they occur. A score of ≥70 can be used as the cut-point to judge self-care adequacy. We strongly discourage users from calculating a total, combined SCHFI score. Instead, the data will be far more useful if the scales (maintenance, management, confidence) are used individually. Each scale is standardized to a score of 100. Use the following formula to compute a standardized: Maintenance: (sum of Section A items - 10) * 3.333 Management: (sum of Section B items - 4) * 5 Confidence: (sum of Section C items - 6) * 5.56
2 secondary outcomes
Results in health
Time frame: Change from baseline results in health at 3 months
Quality of life related to health
Time frame: Change from baselineQuality of life related to health punctuation at 3 months
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 2 Jul 2021.
- Riegel, B., Lee, C. S., Dickson, V. V., \& Carlson, B. (2009). An Update on the Self-Care of Heart Failure Index. The Journal of Cardiovascular Nursing, 24(6), 485-497Link provided by the sponsor.
- Riegel, B., Dickson, V., \& Faulkner., K. (2016). The Situation-Specific Theory of Heart Failure Self-Care: Revised and Updated. The Journal of Cardiovascular Nursing, 31(3), 226-235. doi: 10.1097/JCN.0000000000000244Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Publication of articles derived from the main study
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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.
EUGENIA HERRERA GUERRA, NURSE principal investigator
Universidad Nacional de Colombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TOMAS and Regular attention in people with Heart Failure, run by Universidad Nacional de Colombia at 1 site in Colombia.
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 2 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 2 Jul 2021. 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 Colombia. 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?
Self-care of heart failure index (time frame: Change from baseline self-care for heart failure index at 3 months). 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 2 Jul 2021; AzTrials last refreshed its copy on 7 Nov 2026.