Medication AdherenceECHONCT03162848
SystemCHANGE™ Intervention on Medication Adherence in Older Adults With Heart Failure
A study testing SystemCHANGE in people with Medication Adherence and Heart Failure, run by University of Missouri, Kansas City at 1 site in United States.
Trial summary
The purpose of this pilot RCT study is to evaluate the acceptability and feasibility of a SystemCHANGE™ intervention to improve medication adherence in older adults with heart failure. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence, Heart Failure, Aging
- What is being tested?
- SystemCHANGE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 30 Apr 2018
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 50 years or older
- HF diagnosis confirmed by their physician utilizing their most recent ejection fraction
- prescribed diuretics
- self-administering medications
- able to open an electronic cap
- able to speak, hear and understand English
- not hospitalized,
- no cognitive impairment as determined by a score of 4 or greater on the 6-item mini-mental status exam.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of SystemCHANGE™ Intervention on Medication Adherence in Older Adults With Heart Failure: A Pilot RCT
The purpose of this pilot RCT study is to evaluate the acceptability and feasibility of a SystemCHANGE™ intervention to improve medication adherence in older adults with heart failure. The intervention focuses on changing the individual's environment by incorporating medication taking into existing routines using small experiments with feedback, and receiving support from people who impact routines.
- Conditions
- Medication Adherence, Heart Failure, Aging
- Being tested
- SystemCHANGE
- Medical subject headings
- Medication Adherence, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SystemCHANGEBehavioural
At initial home visit, the PI will work with the participant to identify important people for medication taking, routines, and cycles of routines. Possible solutions to incorporate medication taking into routines will be identified by the participant and PI and the participant will start implementing these solutions. Medication adherence will continuously be monitored using medication event monitoring systems. At one month, the participant will be sent a report on medication taking and a phone call will occur with the PI to discuss if solutions improved medication adherence or if other solutions need to be implemented. At month two, the intervention will end but participants are urged to continue to use solutions long term.
| Study group | Role | What they receive |
|---|---|---|
| SystemCHANGE intervention | Experimental | The SystemCHANGE™ intervention utilizes the Socioecological Model and Plan-Do-Check Act model as its framework and focuses on changing the individual's environment to change behavior using small experiments with feedback. Receives: Behavioral: SystemCHANGE |
| Attention Control | No intervention | The attention control group will receive education at baseline, 1 month, and 2 months following America Heart Association brochures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and feasibility using open ended questionnaire
open ended questionnaire asking participants about acceptability and feasibility
Measured: one point in time at the end of the maintenance phase which is 3 months after randomization into groups
Secondary outcomes (3)
Systems thinking using questionnaire
questionnaire asking about personal systems behavior perceptions
Measured: baseline and after 2 month intervention phase
Kansas City Cardiomyopathy Questionnaire
heart failure outcomes - SOB, fatigue, swelling, activity tolerance
Measured: baseline and after 2 month intervention phase
Medication adherence using medication event monitoring systems
Medication event monitoring systems
Measured: after randomization through end of maintenance phase for a total of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start1 Sep 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Andrews, University of Missouri, Kansas City
- Investigators
- Angela Andrews, PhD(c), Principal investigator, University of Missouri, Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162848
- Sponsor's protocol ID
- 17-130
- Acronym
- ECHO
- Status last verified
- May 2019
- First submitted
- 11 May 2017
- Last updated
- 28 May 2019
- 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 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of SystemCHANGE™ Intervention on Medication Adherence in Older Adults With Heart Failure: A Pilot RCT
- ClinicalTrials.gov ID
- NCT03162848
- Acronym / sponsor ID
- ECHO / 17-130
- Conditions
- Medication Adherence, Heart Failure, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 22 May 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 pilot RCT study is to evaluate the acceptability and feasibility of a SystemCHANGE™ intervention to improve medication adherence in older adults with heart failure. The intervention focuses on changing the individual's environment by incorporating medication taking into existing routines using small experiments with feedback, and receiving support from people who impact routines.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SystemCHANGE intervention | Experimental | Behavioral: SystemCHANGEThe SystemCHANGE™ intervention utilizes the Socioecological Model and Plan-Do-Check Act model as its framework and focuses on changing the individual's environment to change behavior using small experiments with feedback. |
| Attention Control | No intervention | –The attention control group will receive education at baseline, 1 month, and 2 months following America Heart Association brochures. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age 50 years or older
- HF diagnosis confirmed by their physician utilizing their most recent ejection fraction
- prescribed diuretics
- self-administering medications
- able to open an electronic cap
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SystemCHANGEAt initial home visit, the PI will work with the participant to identify important people for medication taking, routines, and cycles of routines. Possible solutions to incorporate medication taking into routines will be identified by the participant and PI and the participant will start implementing these solutions. Medication adherence will continuously be monitored using medication event monitoring systems. At one month, the participant will be sent a report on medication taking and a phone call will occur with the PI to discuss if solutions improved medication adherence or if other solutions need to be implemented. At month two, the intervention will end but participants are urged to continue to use solutions long term. | Behavioural | SystemCHANGE intervention |
Primary outcome
Acceptability and feasibility using open ended questionnaire
Time frame: one point in time at the end of the maintenance phase which is 3 months after randomization into groups
open ended questionnaire asking participants about acceptability and feasibility
3 secondary outcomes
Systems thinking using questionnaire
Time frame: baseline and after 2 month intervention phase
Kansas City Cardiomyopathy Questionnaire
Time frame: baseline and after 2 month intervention phase
Medication adherence using medication event monitoring systems
Time frame: after randomization through end of maintenance phase for a total of 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 28 May 2019.
- 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.
Angela Andrews, PhD(c) principal investigator
University of Missouri, Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SystemCHANGE in people with Medication Adherence and Heart Failure, run by University of Missouri, Kansas City at 1 site in United States.
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 8 inclusion and 0 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 28 May 2019. 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 United States. 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?
Acceptability and feasibility using open ended questionnaire (time frame: one point in time at the end of the maintenance phase which is 3 months after randomization into groups). 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 28 May 2019.