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Improving Caregiver Mediated Medication Management- The 3M Study

Improving Caregiver Mediated Medication Management

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03127930
Enrollment
183
Registered
2017-04-25
Start date
2010-06-01
Completion date
2013-07-30
Last updated
2017-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Management

Keywords

Cognitive Impairment, Memory loss, Caregivers, Medication adherence, Medication compliance, Medication management, Problem solving, Quality of Life, Health resource utilization, Community dwelling

Brief 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. 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: 1. 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. 2. 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.

Interventions

BEHAVIORALIntervention

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.

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Masking description

Participants and outcomes assessors were not blind to the intervention by nature o the protocol. Investigators and analysts were blinded to study group assignment.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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. \-

Exclusion criteria

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. \-

Design outcomes

Primary

MeasureTime frameDescription
Medication management assessed by investigator developed Medication Deficiency Checklist- post-treatment8 weeksImproved medication management of patient's medications by caregiver at post-intervention.
Medication management-assessed by investigator developed Medication Deficiency Checklist- post maintenance16 weeksMaintenance 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 followup24 weeksMaintenance of improved medication management of patient's medications by caregiver after a no treatment followup period.

Secondary

MeasureTime frameDescription
Patient outcomes- medical utilization-Investigator developed Unscheduled Event Checklist24 weeksdecrease medical utilization such as md visits, emergency visits, and hospitalizations
Caregiver outcome- Improved quality of life via Medical Outcome Short Form (SF-36)24 weeksImprovement of caregiver's quality of life over time

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026