Medication Non AdherenceNCT04717297
Tailored Medication Management Intervention
A study testing Medication Management Remote Intervention and Medication Management In-Person Intervention in people with Medication Non Adherence and Polypharmacy, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Successful medication management is an essential instrumental activity of daily living (IADL) for older adults with polypharmacy; however, between 40%-70% of older adults fail to take their medications as prescribed. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Medication Non Adherence, Polypharmacy
- What is being tested?
- Medication Management Remote Intervention and Medication Management In-Person Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2021to 31 Dec 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 and older
- takes 5 or more medications
- Decreased medication adherence (one or more "yes" responses on Medication Adherence Rating Scale (MARS))
Who cannot join
- Cognitive impairment as indicated by Short Blessed Test (SBT) score of 10 or more
- Lives in institutional setting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Tailored Medication Management Intervention for Older Adults
Successful medication management is an essential instrumental activity of daily living (IADL) for older adults with polypharmacy; however, between 40%-70% of older adults fail to take their medications as prescribed. Providing interventions to address medication management and restore performance for this IADL is within the scope of practice for occupational therapy (OT), however, there is paucity of evidence for OT interventions to improve medication management in community-dwelling older adults. We have developed a tailored medication management intervention (TIMM) for community-dwelling older adults which recognizes the unique context in which medication management occurs (the home) and addresses the personal and environmental barriers experienced by older adults. TIMM is delivered in the home, by an OT, and in collaboration with a pharmacist to reduce inappropriate polypharmacy.
Read the detailed description
Almost 70% of older adults experience multimorbidity and medication is often the first intervention used to manage it. In fact, 90% of older adults take at least one medication and 36% take 5 or more, commonly known as polypharmacy. When taken correctly, medication can extend life-expectancy and improve quality of life. However, estimates show 40-75% of community-dwelling older adults are nonadherent, or deviate from their medication regimen. These older adults are at an increased risk of nonadherence because the physical changes associated with multimorbidity including decreased memory, fine motor skills, and visual acuity and because of the complexity polypharmacy adds to a medication routine. Nearly 43% of older adults with polypharmacy take medications that are inappropriate and can cause negative long term physical and cognitive function, which further complicates the mediation management process.
Nonadherence has significant consequences which include increased health care costs, falls, institutionalization, and decreased medication effectiveness, quality of life. In fact, improving medication adherence has been identified as a public health concern by the World Health Organization. Despite this, interventions designed to improve adherence in older adults remain largely ineffective. The majority of interventions are disease or medication specific or are implemented with a "one size fits all" approach (e.g. providing standard pill organizers that may be difficult for some older adults to open). Furthermore, interventions are often implemented in a clinical setting such as doctor's office or hospital and do not consider the unique home environment where medication management typically occurs. Home environments can offer support (i.e. caregiver to set up medications) or barriers (i.e. low lighting that makes medications difficult to see) to medication management. Given the complexity of each older adult's risk factors and home environment, a more tailored, individualized approach must be considered.
Tailored, individualized interventions aimed at remediating the environmental barriers in the home have been successful in improving daily activity performance for older adults. However, this type of intervention has not been tested specifically to improve medication adherence in older adults with multimorbidity and polypharmacy. We propose a tailored, individualized medication management intervention (TIMM) for community-dwelling older adults with multimorbidity and polypharmacy. TIMM is an interdisciplinary, compensatory intervention which consists of: 1) an initial in-home evaluation of medication management ability, individual risk factors, and identification of environmental barriers to independence; 2) a medication review by a pharmacist to address polypharmacy; and 3) tailored intervention by an occupational therapist to improve adherence by reducing barriers to medication management.
We will conduct an equivalency randomized control trial to examine the feasibility, acceptability and preliminary efficacy of TIMM delivered remotely and in-person. The use of telehealth to deliver occupational therapy interventions for older adults has become more widely utilized, especially during the last two years. Remote interventions remove many of the barriers to in-home care including access and cost and have been shown to be an effective delivery method for OT and other medical services for older adults. Participants in the treatment group will receive the intervention delivered remotely, and participants in the waitlist control group will receive the intervention in-person, upon completion of their control period.
- Conditions
- Medication Non Adherence, Polypharmacy
- Being tested
- Medication Management Remote Intervention, Waitlist Control, Medication Management In-Person Intervention
- Keywords
- Medication Management, Occupational Therapy, Older adults
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Management Remote InterventionBehavioural
First, the study pharmacist reviews the older adult's medication for potentially inappropriate medications. The pharmacist collaborates with the prescribing physician(s) to deprescribe as indicated. The pharmacist educates the older adult and OT on any changes that were made. The OT and older adult will develop a plan to reduce risk factors and improve medication management. Participants receive tailored compensatory strategies and supports to remediate extrinsic risk factors and modify the home environment to improve medication adherence. The OT provides training and active practice of the compensatory strategies and supports in the home in an effective and safe manner. All components of the intervention will be delivered remotely.
Waitlist ControlBehavioural
A trained research assistant will complete two attention control visits in the homes of participants. Visit will consist of semi-structured interview exploring the participant's life history.
Medication Management In-Person InterventionBehavioural
Participants in the waitlist control will be offered the medication management intervention to be completed in person. If they consent, the study pharmacist will review their medication for potentially inappropriate medications. The pharmacist will collaborate with the prescribing physician(s) to deprescribe any inappropriate medication as indicated. The pharmacist will educate the older adult and OT on any changes. The OT and older adult will develop a plan to reduce risk factors and improve medication management. Participants will receive tailored compensatory strategies and supports to remediate extrinsic risk factors and modify the home environment to improve medication adherence. The OT will provide training and active practice of the compensatory strategies and supports in the home in an effective and safe manner. All components of the intervention will be delivered in person.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Medication Management Remote Intervention Treatment Arm | Experimental | Participants receive a total of three visits (one evaluation/pre-treatment visit and 2 treatment visits) that last 75 minutes each over 4 weeks. Sessions/visits are spaced 1 week apart and will be delivered remotely. Receives: Behavioral: Medication Management Remote Intervention |
| Waitlist Attention Control Arm | Sham comparator | The attention control group will receive two, 75-minute attention visits with a trained research assistant. Upon completion of waitlist period, the participants in the waitlist group will be offered the intervention in person. Receives: Behavioral: Waitlist Control |
| Tailored Medication Management In-Person Intervention Treatment Arm | Experimental | Participants receive a total of three visits (one evaluation/pre-treatment visit and 2 treatment visits) that last 75 minutes each over 4 weeks. Sessions/visits are spaced 1 week apart and will be delivered in-person. Receives: Behavioral: Medication Management In-Person Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Recruitment and retention rate
Measured: 6 months
Dose
Treatment minutes and number of treatment sessions
Measured: 6 months
Treatment Fidelity
Ability to deliver required treatment session elements
Measured: 6 months
Intervention Safety- ER Visits
Number of ER visits
Measured: 6 months
Intervention Safety- Hospitalizations
Number of unplanned hospitalizations
Measured: 6 months
Intervention Safety- Doctor Visits
Number of unplanned doctor visits
Measured: 6 months
Intervention Safety- Falls
Number of falls
Measured: 6 months
Intervention Safety
Number of therapy visits
Measured: 6 months
Intervention Pharmacy Cost
Pharmacist time
Measured: 6 months
Intervention OT Cost
OT time
Measured: 6 months
Intervention Modification Cost
adaptive equipment cost
Measured: 6 months
Secondary outcomes (3)
Medication Management Ability
In-Home Medication Management Evaluation (HOME-Rx) which includes measures of ability to independently manage mediations and barriers to medication management
Measured: 6 months
Potentially Inappropriate Medications
BEERS Criteria for Inappropriate Medication Use in Older Patients
Measured: 6 months
Equivalency
Equivalency of remote vs in person intervention on all primary outcome measures
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start19 Feb 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication Non AdherenceStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Somerville, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717297
- Sponsor's protocol ID
- 202008139
- Status last verified
- Feb 2023
- First submitted
- 13 Jan 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Somerville E, Bollinger R, Keleman A, Haxton M, Sarrami B, Chen SW, Holden B, Yan Y, Stark S. Tailored medication management intervention delivered by occupational therapists for older adults: A study protocol. Br J Occup Ther. 2023 Apr;86(4):257-264. doi: 10.1177/03080226221135366. Epub 2023 Mar 21.
PubMed 40337485
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tailored Medication Management Intervention for Older Adults
- ClinicalTrials.gov ID
- NCT04717297
- Acronym / sponsor ID
- 202008139
- Conditions
- Medication Non Adherence, Polypharmacy
- Keywords
- Medication Management, Occupational Therapy, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Jan 2021 (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.
Successful medication management is an essential instrumental activity of daily living (IADL) for older adults with polypharmacy; however, between 40%-70% of older adults fail to take their medications as prescribed. Providing interventions to address medication management and restore performance for this IADL is within the scope of practice for occupational therapy (OT), however, there is paucity of evidence for OT interventions to improve medication management in community-dwelling older adults. We have developed a tailored medication management intervention (TIMM) for community-dwelling older adults which recognizes the unique context in which medication management occurs (the home) and addresses the personal and environmental barriers experienced by older adults. TIMM is delivered in the home, by an OT, and in collaboration with a pharmacist to reduce inappropriate polypharmacy.
Detailed description
Almost 70% of older adults experience multimorbidity and medication is often the first intervention used to manage it. In fact, 90% of older adults take at least one medication and 36% take 5 or more, commonly known as polypharmacy. When taken correctly, medication can extend life-expectancy and improve quality of life. However, estimates show 40-75% of community-dwelling older adults are nonadherent, or deviate from their medication regimen. These older adults are at an increased risk of nonadherence because the physical changes associated with multimorbidity including decreased memory, fine motor skills, and visual acuity and because of the complexity polypharmacy adds to a medication routine. Nearly 43% of older adults with polypharmacy take medications that are inappropriate and can cause negative long term physical and cognitive function, which further complicates the mediation management process.
Nonadherence has significant consequences which include increased health care costs, falls, institutionalization, and decreased medication effectiveness, quality of life. In fact, improving medication adherence has been identified as a public health concern by the World Health Organization. Despite this, interventions designed to improve adherence in older adults remain largely ineffective. The majority of interventions are disease or medication specific or are implemented with a "one size fits all" approach (e.g. providing standard pill organizers that may be difficult for some older adults to open). Furthermore, interventions are often implemented in a clinical setting such as doctor's office or hospital and do not consider the unique home environment where medication management typically occurs. Home environments can offer support (i.e. caregiver to set up medications) or barriers (i.e. low lighting that makes medications difficult to see) to medication management. Given the complexity of each older adult's risk factors and home environment, a more tailored, individualized approach must be considered.
Tailored, individualized interventions aimed at remediating the environmental barriers in the home have been successful in improving daily activity performance for older adults. However, this type of intervention has not been tested specifically to improve medication adherence in older adults with multimorbidity and polypharmacy. We propose a tailored, individualized medication management intervention (TIMM) for community-dwelling older adults with multimorbidity and polypharmacy. TIMM is an interdisciplinary, compensatory intervention which consists of: 1) an initial in-home evaluation of medication management ability, individual risk factors, and identification of environmental barriers to independence; 2) a medication review by a pharmacist to address polypharmacy; and 3) tailored intervention by an occupational therapist to improve adherence by reducing barriers to medication management.
We will conduct an equivalency randomized control trial to examine the feasibility, acceptability and preliminary efficacy of TIMM delivered remotely and in-person. The use of telehealth to deliver occupational therapy interventions for older adults has become more widely utilized, especially during the last two years. Remote interventions remove many of the barriers to in-home care including access and cost and have been shown to be an effective delivery method for OT and other medical services for older adults. Participants in the treatment group will receive the intervention delivered remotely, and participants in the waitlist control group will receive the intervention in-person, upon completion of their control period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tailored Medication Management Remote Intervention Treatment Arm | Experimental | Behavioral: Medication Management Remote InterventionParticipants receive a total of three visits (one evaluation/pre-treatment visit and 2 treatment visits) that last 75 minutes each over 4 weeks. Sessions/visits are spaced 1 week apart and will be delivered remotely. |
| Waitlist Attention Control Arm | Sham comparator | Behavioral: Waitlist ControlThe attention control group will receive two, 75-minute attention visits with a trained research assistant. Upon completion of waitlist period, the participants in the waitlist group will be offered the intervention in person. |
| Tailored Medication Management In-Person Intervention Treatment Arm | Experimental | Behavioral: Medication Management In-Person InterventionParticipants receive a total of three visits (one evaluation/pre-treatment visit and 2 treatment visits) that last 75 minutes each over 4 weeks. Sessions/visits are spaced 1 week apart and will be delivered in-person. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65 and older
- takes 5 or more medications
- Decreased medication adherence (one or more "yes" responses on Medication Adherence Rating Scale (MARS))
Key exclusion criteria (2 listed)
- Cognitive impairment as indicated by Short Blessed Test (SBT) score of 10 or more
- Lives in institutional setting
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 |
|---|---|---|
| Medication Management Remote InterventionFirst, the study pharmacist reviews the older adult's medication for potentially inappropriate medications. The pharmacist collaborates with the prescribing physician(s) to deprescribe as indicated. The pharmacist educates the older adult and OT on any changes that were made. The OT and older adult will develop a plan to reduce risk factors and improve medication management. Participants receive tailored compensatory strategies and supports to remediate extrinsic risk factors and modify the home environment to improve medication adherence. The OT provides training and active practice of the compensatory strategies and supports in the home in an effective and safe manner. All components of the intervention will be delivered remotely. | Behavioural | Tailored Medication Management Remote Intervention Treatment Arm |
| Waitlist ControlA trained research assistant will complete two attention control visits in the homes of participants. Visit will consist of semi-structured interview exploring the participant's life history. | Behavioural | Waitlist Attention Control Arm |
| Medication Management In-Person InterventionParticipants in the waitlist control will be offered the medication management intervention to be completed in person. If they consent, the study pharmacist will review their medication for potentially inappropriate medications. The pharmacist will collaborate with the prescribing physician(s) to deprescribe any inappropriate medication as indicated. The pharmacist will educate the older adult and OT on any changes. The OT and older adult will develop a plan to reduce risk factors and improve medication management. Participants will receive tailored compensatory strategies and supports to remediate extrinsic risk factors and modify the home environment to improve medication adherence. The OT will provide training and active practice of the compensatory strategies and supports in the home in an effective and safe manner. All components of the intervention will be delivered in person. | Behavioural | Tailored Medication Management In-Person Intervention Treatment Arm |
Primary outcome
Recruitment
Time frame: 6 months
Recruitment and retention rate
Dose
Time frame: 6 months
Treatment minutes and number of treatment sessions
Treatment Fidelity
Time frame: 6 months
Ability to deliver required treatment session elements
Intervention Safety- ER Visits
Time frame: 6 months
Number of ER visits
Intervention Safety- Hospitalizations
Time frame: 6 months
Number of unplanned hospitalizations
Intervention Safety- Doctor Visits
Time frame: 6 months
Number of unplanned doctor visits
Intervention Safety- Falls
Time frame: 6 months
Number of falls
Intervention Safety
Time frame: 6 months
Number of therapy visits
Intervention Pharmacy Cost
Time frame: 6 months
Pharmacist time
Intervention OT Cost
Time frame: 6 months
OT time
Intervention Modification Cost
Time frame: 6 months
adaptive equipment cost
3 secondary outcomes
Medication Management Ability
Time frame: 6 months
Potentially Inappropriate Medications
Time frame: 6 months
Equivalency
Time frame: 6 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 1 Mar 2023.
- Derived from this study: PubMed 40337485Somerville E, Bollinger R, Keleman A, Haxton M, Sarrami B, Chen SW, Holden B, Yan Y, Stark S. Tailored medication management intervention delivered by occupational therapists for older adults: A study protocol. Br J Occup Ther. 2023 Apr;86(4):257-264. doi: 10.1177/03080226221135366. Epub 2023 Mar 21.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Management Remote Intervention and Medication Management In-Person Intervention in people with Medication Non Adherence and Polypharmacy, run by Washington University School of Medicine 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 3 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 1 Mar 2023. 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. Some participants in this study may receive a placebo. 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?
Recruitment (time frame: 6 months). The study lists 11 primary outcomes in all. 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 NCT04717297, which also lists 1 linked publication.
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 1 Mar 2023; AzTrials last refreshed its copy on 27 Oct 2026.