Medication ManagementNCT03127930
Improving Caregiver Mediated Medication Management- The 3M Study
A study testing Intervention in people with Medication Management, run by University of Pittsburgh.
Trial summary
This study sought to improve medication management by caregivers of community dwelling patients with dementia or simple memory loss. This was done by testing a tailored intervention delivered both in-home and by telephone by either a social worker or nurse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Management
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2010to 30 Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PATIENTS 18 years of age or older; Patient having memory deficit reported by either member of dyad. Be unable to manage their own medications Have a minimum of two co-morbid conditions (one additional condition besides dementia) Have more than one medication prescribed or recommended by an MD. This could include MD recommended supplements and over the counter medications.
- Have an informal caregiver/not a paid caregiver; Live within approximately a 75 mile radius of the University of Pittsburgh.
- INFORMAL/FAMILY CAREGIVERS 18 years of age or older; have access to a telephone for the telephone-delivered intervention and maintenance sessions; have medication management deficiencies as identified by the Medication Management Instrument for Deficiencies on the Elderly (MedMaIDE) at screening; live within a 75 mile radius of the University of Pittsburgh.
- -
Who cannot join
- PATIENTS:
- major physical/aggressive behavior problems identified at screening using the Revised Memory Behavior Problem Checklist.
- INFORMAL/FAMILY CAREGIVERS:
- hearing impairment without a modified telephone to enhance their ability to hear.
- -
About this study
Official title: Improving Caregiver Mediated Medication Management
This study sought to improve medication management by caregivers of community dwelling patients with dementia or simple memory loss. This was done by testing a tailored intervention delivered both in-home and by telephone by either a social worker or nurse. The intervention was designed to decrease medication deficiencies and improve medication adherence by developing problem solving skills.
Read the detailed description
Objective: The overall purpose of this investigation is to test the efficacy of a tailored caregiver mediated medication management intervention designed for caregivers of community dwelling patients with dementia.
Specific Aims:
Primary Aim:
Examine the efficacy of a tailored caregiver mediated medication management in-home and telephone delivered intervention designed to decrease medication taking deficiencies and daily hassles and improve medication adherence of caregivers of community dwelling patients with dementia vs. standard education/usual care group of caregivers over time.
Hypothesis 1 Immediately post-treatment (8 weeks), there will be a decrease in medication taking deficiencies and daily hassles and an improvement in caregiver medication adherence in the treatment compared to the usual care group.
Hypothesis 2 Immediately post-maintenance (16 weeks), there will be a sustained decrease in medication taking deficiencies and daily hassles and an improvement in caregiver medication adherence in the treatment group compared to the usual care group.
Hypothesis 3 At 8 weeks post-maintenance (24 weeks), there will continue to be a sustained decrease in medication taking deficiencies and daily hassles and an improvement in caregiver medication adherence in the treatment group compared to the usual care group.
Secondary Aims:
- Examine the efficacy of a tailored caregiver mediated medication management in-home and telephone delivered intervention designed to decrease medication taking deficiencies and daily hassles and increase medication adherence of caregivers of community dwelling patients with dementia vs. standard education/usual care group of caregivers on the distal outcome of adverse patient outcomes including unplanned doctor's visits, emergency room visits, and hospitalizations over time.
- Examine the efficacy of a tailored caregiver mediated medication management in-home and telephone delivered intervention designed to decrease medication taking and daily hassles and increase medication adherence of caregivers of community dwelling patients with dementia vs. standard education/usual care group of caregivers on the distal outcome of health related quality of life in both caregivers and community dwelling patients over time.
Significance: This study is both timely and significant because of the growing number of patients with dementia who need supportive services of family members, as well as from the health care system. This study is addressing a very timely issue, the reduction of medication deficiencies that can lead to errors. This is a priority patient safety issue regardless of whether the medications are given by a professional healthcare provider or an informal family caregiver. Additionally, this intervention has the potential for translation into geriatric practices and lay community or support groups.
- Conditions
- Medication Management
- Being tested
- Intervention
- Keywords
- Cognitive Impairment, Memory loss, Caregivers, Medication adherence, Medication compliance, Medication management, Problem solving, Quality of Life, Health resource utilization, Community dwelling
- Medical subject headings
- Cognitive Dysfunction, Memory Disorders, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Also called Problem Solving training to improve medication management
Participants receive 5 individualized contacts (home visits and phone calls) with either a social worker or a nurse to develop problem solving skills as applied to medication management.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention: Participants receive both usual care including a standard brochure on patient management provided by the Alzheimer's Association plus a tailored problem-solving intervention to improve caregiver's management of medications for their family or friend care recipient who has memory deficit. Receives: Behavioral: Intervention |
| Usual Care | No intervention | No Intervention: Participants do not receive the problem solving intervention and are followed as a Usual Care condition including receiving a standard brochure on patient management provided by the Alzheimer's Association. . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication management assessed by investigator developed Medication Deficiency Checklist- post-treatment
Improved medication management of patient's medications by caregiver at post-intervention.
Measured: 8 weeks
Medication management-assessed by investigator developed Medication Deficiency Checklist- post maintenance
Maintenance of improved medication management of patient's medications by caregiver following a booster/maintenance period
Measured: 16 weeks
Medication management-assessed by investigator developed Medication Deficiency Checklist- post followup
Maintenance of improved medication management of patient's medications by caregiver after a no treatment followup period.
Measured: 24 weeks
Secondary outcomes (2)
Patient outcomes- medical utilization-Investigator developed Unscheduled Event Checklist
decrease medical utilization such as md visits, emergency visits, and hospitalizations
Measured: 24 weeks
Caregiver outcome- Improved quality of life via Medical Outcome Short Form (SF-36)
Improvement of caregiver's quality of life over time
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start1 Jun 2010
- Primary completion30 Jul 2013
- Study completion30 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Medication ManagementStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Social Cognitive and Self Efficacy Theory drove the problem-solving tailored intervention delivered via face to face and telephone by either a master's prepared social worker or nurse.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith Erlen, University of Pittsburgh
- Investigators
- Judith A Erlen, RN, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127930
- Sponsor's protocol ID
- PRO08050015
- Status last verified
- May 2017
- First submitted
- 18 Apr 2017
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erlen JA, Lingler J, Sereika SM, Tamres LK, Happ MB, Tang F. Characterizing caregiver-mediated medication management in patients with memory loss. J Gerontol Nurs. 2013 Apr;39(4):30-9. doi: 10.3928/00989134-20130220-91. Epub 2013 Feb 28.
PubMed 23445184Lingler JH, Sereika SM, Amspaugh CM, Arida JA, Happ ME, Houze MP, Kaufman RR, Knox ML, Tamres LK, Tang F, Erlen JA. An intervention to maximize medication management by caregivers of persons with memory loss: Intervention overview and two-month outcomes. Geriatr Nurs. 2016 May-Jun;37(3):186-91. doi: 10.1016/j.gerinurse.2015.12.002. Epub 2016 Jan 21.
PubMed 26804450Tang F, Jang H, Lingler J, Tamres LK, Erlen JA. Stressors and Caregivers' Depression: Multiple Mediators of Self-Efficacy, Social Support, and Problem-Solving Skill. Soc Work Health Care. 2015;54(7):651-68. doi: 10.1080/00981389.2015.1054058.
PubMed 26317766
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Caregiver Mediated Medication Management
- ClinicalTrials.gov ID
- NCT03127930
- Acronym / sponsor ID
- PRO08050015
- Conditions
- Medication Management
- Keywords
- Cognitive Impairment, Memory loss, Caregivers, Medication adherence, Medication compliance, Medication management, Problem solving, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Jun 2010 (actual)
- Primary completion
- 30 Jul 2013 (actual)
- Study completion
- 30 Jul 2013 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study sought to improve medication management by caregivers of community dwelling patients with dementia or simple memory loss. This was done by testing a tailored intervention delivered both in-home and by telephone by either a social worker or nurse. The intervention was designed to decrease medication deficiencies and improve medication adherence by developing problem solving skills.
Detailed description
Objective: The overall purpose of this investigation is to test the efficacy of a tailored caregiver mediated medication management intervention designed for caregivers of community dwelling patients with dementia.
Specific Aims:
Primary Aim:
Examine the efficacy of a tailored caregiver mediated medication management in-home and telephone delivered intervention designed to decrease medication taking deficiencies and daily hassles and improve medication adherence of caregivers of community dwelling patients with dementia vs. standard education/usual care group of caregivers over time.
Hypothesis 1 Immediately post-treatment (8 weeks), there will be a decrease in medication taking deficiencies and daily hassles and an improvement in caregiver medication adherence in the treatment compared to the usual care group.
Hypothesis 2 Immediately post-maintenance (16 weeks), there will be a sustained decrease in medication taking deficiencies and daily hassles and an improvement in caregiver medication adherence in the treatment group compared to the usual care group.
Hypothesis 3 At 8 weeks post-maintenance (24 weeks), there will continue to be a sustained decrease in medication taking deficiencies and daily hassles and an improvement in caregiver medication adherence in the treatment group compared to the usual care group.
Secondary Aims:
- Examine the efficacy of a tailored caregiver mediated medication management in-home and telephone delivered intervention designed to decrease medication taking deficiencies and daily hassles and increase medication adherence of caregivers of community dwelling patients with dementia vs. standard education/usual care group of caregivers on the distal outcome of adverse patient outcomes including unplanned doctor's visits, emergency room visits, and hospitalizations over time.
- Examine the efficacy of a tailored caregiver mediated medication management in-home and telephone delivered intervention designed to decrease medication taking and daily hassles and increase medication adherence of caregivers of community dwelling patients with dementia vs. standard education/usual care group of caregivers on the distal outcome of health related quality of life in both caregivers and community dwelling patients over time.
Significance: This study is both timely and significant because of the growing number of patients with dementia who need supportive services of family members, as well as from the health care system. This study is addressing a very timely issue, the reduction of medication deficiencies that can lead to errors. This is a priority patient safety issue regardless of whether the medications are given by a professional healthcare provider or an informal family caregiver. Additionally, this intervention has the potential for translation into geriatric practices and lay community or support groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Social Cognitive and Self Efficacy Theory drove the problem-solving tailored intervention delivered via face to face and telephone by either a master's prepared social worker or nurse.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionIntervention: Participants receive both usual care including a standard brochure on patient management provided by the Alzheimer's Association plus a tailored problem-solving intervention to improve caregiver's management of medications for their family or friend care recipient who has memory deficit. |
| Usual Care | No intervention | –No Intervention: Participants do not receive the problem solving intervention and are followed as a Usual Care condition including receiving a standard brochure on patient management provided by the Alzheimer's Association. . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- PATIENTS 18 years of age or older; Patient having memory deficit reported by either member of dyad. Be unable to manage their own medications Have a minimum of two co-morbid conditions (one additional condition besides dementia) Have more than one medication prescribed or recommended by an MD. This could include MD recommended supplements and over the counter medications.
- Have an informal caregiver/not a paid caregiver; Live within approximately a 75 mile radius of the University of Pittsburgh.
- INFORMAL/FAMILY CAREGIVERS 18 years of age or older; have access to a telephone for the telephone-delivered intervention and maintenance sessions; have medication management deficiencies as identified by the Medication Management Instrument for Deficiencies on the Elderly (MedMaIDE) at screening; live within a 75 mile radius of the University of Pittsburgh.
- -
Key exclusion criteria (5 listed)
- major physical/aggressive behavior problems identified at screening using the Revised Memory Behavior Problem Checklist.
- hearing impairment without a modified telephone to enhance their ability to hear.
- -
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 |
|---|---|---|
| InterventionAlso: Problem Solving training to improve medication managementParticipants receive 5 individualized contacts (home visits and phone calls) with either a social worker or a nurse to develop problem solving skills as applied to medication management. | Behavioural | Intervention |
Primary outcome
Medication management assessed by investigator developed Medication Deficiency Checklist- post-treatment
Time frame: 8 weeks
Improved medication management of patient's medications by caregiver at post-intervention.
Medication management-assessed by investigator developed Medication Deficiency Checklist- post maintenance
Time frame: 16 weeks
Maintenance of improved medication management of patient's medications by caregiver following a booster/maintenance period
Medication management-assessed by investigator developed Medication Deficiency Checklist- post followup
Time frame: 24 weeks
Maintenance of improved medication management of patient's medications by caregiver after a no treatment followup period.
2 secondary outcomes
Patient outcomes- medical utilization-Investigator developed Unscheduled Event Checklist
Time frame: 24 weeks
Caregiver outcome- Improved quality of life via Medical Outcome Short Form (SF-36)
Time frame: 24 weeks
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 4 May 2017.
- Results publication: PubMed 23445184Erlen JA, Lingler J, Sereika SM, Tamres LK, Happ MB, Tang F. Characterizing caregiver-mediated medication management in patients with memory loss. J Gerontol Nurs. 2013 Apr;39(4):30-9. doi: 10.3928/00989134-20130220-91. Epub 2013 Feb 28.
- Results publication: PubMed 26804450Lingler JH, Sereika SM, Amspaugh CM, Arida JA, Happ ME, Houze MP, Kaufman RR, Knox ML, Tamres LK, Tang F, Erlen JA. An intervention to maximize medication management by caregivers of persons with memory loss: Intervention overview and two-month outcomes. Geriatr Nurs. 2016 May-Jun;37(3):186-91. doi: 10.1016/j.gerinurse.2015.12.002. Epub 2016 Jan 21.
- Results publication: PubMed 26317766Tang F, Jang H, Lingler J, Tamres LK, Erlen JA. Stressors and Caregivers' Depression: Multiple Mediators of Self-Efficacy, Social Support, and Problem-Solving Skill. Soc Work Health Care. 2015;54(7):651-68. doi: 10.1080/00981389.2015.1054058.
- 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.
Judith A Erlen, RN, PhD principal investigator
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Medication Management, run by University of Pittsburgh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Medication management assessed by investigator developed Medication Deficiency Checklist- post-treatment (time frame: 8 weeks). The study lists 3 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 NCT03127930, 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 4 May 2017.