AnticoagulantsNCT03864900
Efficacy of a Health Belief Model Based Intervention for Anticoagulation Adherence
A study testing The medication adherence intervention in people with Anticoagulants, run by National Taipei University of Nursing and Health Sciences at 2 sites in Taiwan.
Trial summary
Inconsistent anticoagulation therapy in AF patients is associated with a higher risk of stroke and abnormal bleeding. The purpose of the study is to investigate the efficacy of a health belief model based self-management of oral anticoagulant therapy intervention on the outcome of medication adherence and the… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Anticoagulants
- What is being tested?
- The medication adherence intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesTaiwan
- Study dates
- 13 Oct 2015to 20 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 20 years of age
- fluent in Mandarin or Taiwanese
- diagnosed with AF
- treated with warfarin or NOACs for anticoagulation.
Who cannot join
- diagnosed with psychological diseases
- diagnosed with uncontrolled hypertension
- diagnosed with the New York Heart Association (NYHA) grade VI heart failure
- implanted with a cardiac pacemaker
- had cardiac surgery in the past three months
- hospitalized for AF in the past three months.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Taipei Medical University WanFang Hospital
Taipei, 116
Taipei Medical University Shuang Ho Hospital
Taipei County, Taipei, 235
About this study
Official title: Efficacy of a Health Belief Model Based Intervention for Anticoagulation Adherence in Patients With Atrial Fibrillation: A Randomized Controlled Trial
Inconsistent anticoagulation therapy in AF patients is associated with a higher risk of stroke and abnormal bleeding. The purpose of the study is to investigate the efficacy of a health belief model based self-management of oral anticoagulant therapy intervention on the outcome of medication adherence and the mediators of knowledge, professional support, health belief, and self-efficacy in patients treated with oral anticoagulants for atrial fibrillation. A randomized clinical trial with repeated measurements was conducted. A convenient sample of 110 adults who were treated with anticoagulants for atrial fibrillation was recruited from two teaching hospitals in northern Taiwan. Participants were randomly assigned 1:1 to either the control group (n = 36) or the intervention group (n = 36) after completion of baseline questionnaires. Patients in the experimental group received the health belief model based anticoagulation adherence intervention, including one 60-minute individual instructions and six 15-minute telephone follow-ups. Participants in the control group received regular medication education, 10-minute individual instruction for health knowledge and six follow-up telephone calls for concerning health. Patients in both groups answered the study questionnaires at three and six months. The generalized estimating equations were used to analyze the efficacy of the intervention for enhancing knowledge, knowledge, perceived benefits, perceived barriers, self-efficacy, and adherence to anticoagulant therapies in patients treated with oral anticoagulants for atrial fibrillation. The results of the study will contribute to the knowledge for improving adherence to oral anticoagulation therapies in patients with atrial fibrillation.
Read the detailed description
BACKGROUND: Inconsistent anticoagulation therapy in AF patients is associated with a higher risk of stroke and abnormal bleeding. However, control of oral anticoagulation therapy in AF patients has been frequently reported as inadequate. Few theoretical based interventions have been tested for enhancing medication adherence in this population. Previous studies showed that the health belief model may offer some advantage over other behavior change theories for enhancing medication adherence in adult with chronic conditions.
PURPOSE: The purpose of the study is to investigate the efficacy of a health belief model based self-management of oral anticoagulant therapy intervention on the outcome of medication adherence and the mediators of knowledge, professional support, health belief, and self-efficacy in patients treated with oral anticoagulants for atrial fibrillation.
METHODS: The study is a randomized clinical trial with repeated measurements. A convenient sample of 72 adults who were treated with anticoagulants for atrial fibrillation was recruited from two teaching hospitals in northern Taiwan. Participants were randomly assigned 1:1 to either the control group (n = 36) or the intervention group (n = 36) after completion of baseline questionnaires. Allocation was balanced by site by using a minimization method. The health belief model based self-management intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls. Participants in the control group received regular medication education, 10-minute individual instruction for health knowledge and six follow-up telephone calls for concerning health. Data were collected at baseline, third month, and sixth month in both groups, by using self-administered questionnaires. The investigator administered the study questionnaire after obtaining informed consent from each subject. The data collection took place at the waiting areas outside the outpatient clinics during the patients' visits to the clinics. For subjects who were unable to read the questionnaire due to vision or other problems, the investigator read each question to help them complete the questionnaire. The instruments include the Atrial Fibrillation Knowledge Scale, Satisfaction Scale about Service and Warfarin Treatment, Belief About Anticoagulation Survey, and Self-Efficacy for Appropriate Medication Use Scale.
DATA ANALYSIS: Data were analyzed using the Statistical Package for Social Sciences 20.0 (SPSS, Inc., Chicago, IL, USA). Descriptive analyses were used to describe study variables. Independent t-tests and one-way analysis of variance (ANOVA) were performed to analyze the baseline equivalent between study groups. The generalized estimating equations were used to analyze the efficacy of the intervention for enhancing knowledge, knowledge, perceived benefits, perceived barriers, self-efficacy, and adherence to anticoagulant therapies in patients treated with oral anticoagulants for atrial fibrillation.
- Conditions
- Anticoagulants
- Being tested
- The medication adherence intervention
- Keywords
- Anticoagulants, Atrial fibrillation, Adherence, Health belief model
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The medication adherence interventionBehavioural
The health belief model based medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Experimental | The medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls. Receives: Behavioral: The medication adherence intervention |
| The control group | No intervention | Participants in the control group received regular medication education, 10-minute individual instruction for health knowledge and six follow-up telephone calls for concerning health. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Short-form Adherence to Refills and Medications Scale (ARMS)
There are seven items in the scale. Subjects were asked to indicate how often they actually miss taking their anticoagulants in each item on a 4-point Likert scale (1_ none of the time to 4_ all of the time). The total score of the 7 items represents the scale score, with a possible range of 7 to 28. A higher score indicates worse adherence to anticoagulation treatment.
Measured: baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.
Secondary outcomes (4)
The Knowledge of Warfarin Anticoagulation Treatment Scale
The 11-item scale covers four areas of warfarin treatment knowledge: administration (e.g., dose, color, and route of administration), interaction with foods, interaction with other drugs, and side effects. There are five choices for each item, and only one of the choices is correct (scored 1). The total score of the 11 items represents the scale score, with a possible range of 0 to 11. Higher scores indicate higher levels of understanding of warfarin treatment. The scale was also modified to measure the NOACs treatment knowledge. To facilitate analysis and comparison, the score of each scale was converted to a scale of 0 to 100 (actual score/possible maximum score x 100).
Measured: baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.
The Perceived Benefits Subscale of the Beliefs About Anticoagulation Survey (BAAS)
The subscale covers 5 potential benefits of taking anticoagulation, including lessening the risk of having a stroke, lowering the chance of being hospitalized, feeling healthier, improving quality of life, and worrying less about the disease. For each item, the subjects indicated their levels of agreement on a 5-point Likert scale (from 1_ strongly disagree to 5_ strongly agree). The potential scores range from 5 to 25 points, with higher scores indicating higher levels of perceived benefits associated with taking anticoagulation.
Measured: baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.
The Concerns About Anticoagulation Therapy Scale
The scale lists ten potential concerns, including drug interactions, forgetting to take anticoagulants, side effects, hospital visits, diet interactions, activity restrictions, impact on work, not helpful, and difficulty of following instructions. The subjects were asked to indicate all concerns that apply to them. Each concern was scored 1. The potential scores range from 0 to 10, with higher scores indicating more concerns.
Measured: baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.
The Self-efficacy for Appropriate Medication Use Scale (SEAMS)
The 13-item scale covers two dimensions of self-efficacy: for taking medications under difficult circumstances and for taking medications under uncertain or changing circumstances. For each item, the subjects indicated their level of confidence about taking medications correctly under a specific circumstance on a three-point response scale (1 _ not confident, 2 _ somewhat confident, and 3 _ very confident). The potential scores range from 13 to 39, with high scores indicating higher levels of self-efficacy for appropriate anticoagulant use.
Measured: baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start13 Oct 2015
- Primary completion20 Apr 2017
- Study completion20 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnticoagulantsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The health belief model based medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University WanFang Hospital, Taipei Medical University Shuang Ho Hospital
- Responsible party
- Principal investigator, Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences
- Investigators
- Tsae Jyy Wang, PhD, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864900
- Sponsor's protocol ID
- 201505054
- Status last verified
- Aug 2021
- First submitted
- 5 Mar 2019
- Last updated
- 22 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiang CE, Wu TJ, Ueng KC, Chao TF, Chang KC, Wang CC, Lin YJ, Yin WH, Kuo JY, Lin WS, Tsai CT, Liu YB, Lee KT, Lin LJ, Lin LY, Wang KL, Chen YJ, Chen MC, Cheng CC, Wen MS, Chen WJ, Chen JH, Lai WT, Chiou CW, Lin JL, Yeh SJ, Chen SA. 2016 Guidelines of the Taiwan Heart Rhythm Society and the Taiwan Society of Cardiology for the management of atrial fibrillation. J Formos Med Assoc. 2016 Nov;115(11):893-952. doi: 10.1016/j.jfma.2016.10.005. Epub 2016 Nov 24.
PubMed 27890386Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Alexandru Popescu B, Schotten U, Van Putte B, Vardas P. 2016 ESC Guidelines for the Management of Atrial Fibrillation Developed in Collaboration With EACTS. Rev Esp Cardiol (Engl Ed). 2017 Jan;70(1):50. doi: 10.1016/j.rec.2016.11.033. No abstract available. English, Spanish.
PubMed 28038729January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.
PubMed 24685669
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Health Belief Model Based Intervention for Anticoagulation Adherence in Patients With Atrial Fibrillation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03864900
- Acronym / sponsor ID
- 201505054
- Conditions
- Anticoagulants
- Keywords
- Anticoagulants, Atrial fibrillation, Adherence, Health belief model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- Taipei Medical University WanFang Hospital, Taipei Medical University Shuang Ho Hospital
- Study start
- 13 Oct 2015 (actual)
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 6 Mar 2019 (actual)
- Results
- Posted 14 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inconsistent anticoagulation therapy in AF patients is associated with a higher risk of stroke and abnormal bleeding. The purpose of the study is to investigate the efficacy of a health belief model based self-management of oral anticoagulant therapy intervention on the outcome of medication adherence and the mediators of knowledge, professional support, health belief, and self-efficacy in patients treated with oral anticoagulants for atrial fibrillation. A randomized clinical trial with repeated measurements was conducted. A convenient sample of 110 adults who were treated with anticoagulants for atrial fibrillation was recruited from two teaching hospitals in northern Taiwan. Participants were randomly assigned 1:1 to either the control group (n = 36) or the intervention group (n = 36) after completion of baseline questionnaires. Patients in the experimental group received the health belief model based anticoagulation adherence intervention, including one 60-minute individual instructions and six 15-minute telephone follow-ups. Participants in the control group received regular medication education, 10-minute individual instruction for health knowledge and six follow-up telephone calls for concerning health. Patients in both groups answered the study questionnaires at three and six months. The generalized estimating equations were used to analyze the efficacy of the intervention for enhancing knowledge, knowledge, perceived benefits, perceived barriers, self-efficacy, and adherence to anticoagulant therapies in patients treated with oral anticoagulants for atrial fibrillation. The results of the study will contribute to the knowledge for improving adherence to oral anticoagulation therapies in patients with atrial fibrillation.
Detailed description
BACKGROUND: Inconsistent anticoagulation therapy in AF patients is associated with a higher risk of stroke and abnormal bleeding. However, control of oral anticoagulation therapy in AF patients has been frequently reported as inadequate. Few theoretical based interventions have been tested for enhancing medication adherence in this population. Previous studies showed that the health belief model may offer some advantage over other behavior change theories for enhancing medication adherence in adult with chronic conditions.
PURPOSE: The purpose of the study is to investigate the efficacy of a health belief model based self-management of oral anticoagulant therapy intervention on the outcome of medication adherence and the mediators of knowledge, professional support, health belief, and self-efficacy in patients treated with oral anticoagulants for atrial fibrillation.
METHODS: The study is a randomized clinical trial with repeated measurements. A convenient sample of 72 adults who were treated with anticoagulants for atrial fibrillation was recruited from two teaching hospitals in northern Taiwan. Participants were randomly assigned 1:1 to either the control group (n = 36) or the intervention group (n = 36) after completion of baseline questionnaires. Allocation was balanced by site by using a minimization method. The health belief model based self-management intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls. Participants in the control group received regular medication education, 10-minute individual instruction for health knowledge and six follow-up telephone calls for concerning health. Data were collected at baseline, third month, and sixth month in both groups, by using self-administered questionnaires. The investigator administered the study questionnaire after obtaining informed consent from each subject. The data collection took place at the waiting areas outside the outpatient clinics during the patients' visits to the clinics. For subjects who were unable to read the questionnaire due to vision or other problems, the investigator read each question to help them complete the questionnaire. The instruments include the Atrial Fibrillation Knowledge Scale, Satisfaction Scale about Service and Warfarin Treatment, Belief About Anticoagulation Survey, and Self-Efficacy for Appropriate Medication Use Scale.
DATA ANALYSIS: Data were analyzed using the Statistical Package for Social Sciences 20.0 (SPSS, Inc., Chicago, IL, USA). Descriptive analyses were used to describe study variables. Independent t-tests and one-way analysis of variance (ANOVA) were performed to analyze the baseline equivalent between study groups. The generalized estimating equations were used to analyze the efficacy of the intervention for enhancing knowledge, knowledge, perceived benefits, perceived barriers, self-efficacy, and adherence to anticoagulant therapies in patients treated with oral anticoagulants for atrial fibrillation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The health belief model based medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls.
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Behavioral: The medication adherence interventionThe medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls. |
| The control group | No intervention | –Participants in the control group received regular medication education, 10-minute individual instruction for health knowledge and six follow-up telephone calls for concerning health. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 20 years of age
- fluent in Mandarin or Taiwanese
- diagnosed with AF
- treated with warfarin or NOACs for anticoagulation.
Key exclusion criteria (6 listed)
- diagnosed with psychological diseases
- diagnosed with uncontrolled hypertension
- diagnosed with the New York Heart Association (NYHA) grade VI heart failure
- implanted with a cardiac pacemaker
- had cardiac surgery in the past three months
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 |
|---|---|---|
| The medication adherence interventionThe health belief model based medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls. | Behavioural | The intervention group |
Primary outcome
The Short-form Adherence to Refills and Medications Scale (ARMS)
Time frame: baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.
There are seven items in the scale. Subjects were asked to indicate how often they actually miss taking their anticoagulants in each item on a 4-point Likert scale (1_ none of the time to 4_ all of the time). The total score of the 7 items represents the scale score, with a possible range of 7 to 28. A higher score indicates worse adherence to anticoagulation treatment.
4 secondary outcomes
The Knowledge of Warfarin Anticoagulation Treatment Scale
Time frame: baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.
The Perceived Benefits Subscale of the Beliefs About Anticoagulation Survey (BAAS)
Time frame: baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.
The Concerns About Anticoagulation Therapy Scale
Time frame: baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.
The Self-efficacy for Appropriate Medication Use Scale (SEAMS)
Time frame: baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27890386Chiang CE, Wu TJ, Ueng KC, Chao TF, Chang KC, Wang CC, Lin YJ, Yin WH, Kuo JY, Lin WS, Tsai CT, Liu YB, Lee KT, Lin LJ, Lin LY, Wang KL, Chen YJ, Chen MC, Cheng CC, Wen MS, Chen WJ, Chen JH, Lai WT, Chiou CW, Lin JL, Yeh SJ, Chen SA. 2016 Guidelines of the Taiwan Heart Rhythm Society and the Taiwan Society of Cardiology for the management of atrial fibrillation. J Formos Med Assoc. 2016 Nov;115(11):893-952. doi: 10.1016/j.jfma.2016.10.005. Epub 2016 Nov 24.
- Background: PubMed 28038729Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Alexandru Popescu B, Schotten U, Van Putte B, Vardas P. 2016 ESC Guidelines for the Management of Atrial Fibrillation Developed in Collaboration With EACTS. Rev Esp Cardiol (Engl Ed). 2017 Jan;70(1):50. doi: 10.1016/j.rec.2016.11.033. No abstract available. English, Spanish.
- Background: PubMed 24685669January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.
- Individual participant dataSharing planned: No
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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.
Tsae Jyy Wang, PhD principal investigator
National Taipei University of Nursing and Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The medication adherence intervention in people with Anticoagulants, run by National Taipei University of Nursing and Health Sciences at 2 sites in Taiwan.
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 6 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 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
Yes. Results are posted in the registry (first posted 14 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Short-form Adherence to Refills and Medications Scale (ARMS) (time frame: baseline (T1), 12th week (T2), and 24th week (T3) follow-ups.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03864900, which also lists 3 linked publications.
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 22 Sep 2021.