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Improving Caregiver Mediated Medication Management- The 3M Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03127930
Recruitment Status : Completed
First Posted : April 25, 2017
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Judith Erlen, University of Pittsburgh

Study Description
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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.

Condition or disease Intervention/treatment Phase
Medication Management Behavioral: Intervention Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel 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.
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.
Primary Purpose: Other
Official Title: Improving Caregiver Mediated Medication Management
Actual Study Start Date : June 1, 2010
Actual Primary Completion Date : July 30, 2013
Actual Study Completion Date : July 30, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Medicines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
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.
 Behavioral: Intervention
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.
Other Name: Problem Solving training to improve medication management
No Intervention: Usual Care
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. .


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.


Secondary Outcome Measures :
  1. Patient outcomes- medical utilization-Investigator developed Unscheduled Event Checklist [ Time Frame: 24 weeks ]
    decrease medical utilization such as md visits, emergency visits, and hospitalizations

  2. Caregiver outcome- Improved quality of life via Medical Outcome Short Form (SF-36) [ Time Frame: 24 weeks ]
    Improvement of caregiver's quality of life over time


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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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.

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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03127930


Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Judith A Erlen, RN, PhD University of Pittsburgh
More Information
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Publications of Results:

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Responsible Party: Judith Erlen, Professor of Nursing, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03127930    
Other Study ID Numbers: PRO08050015
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Judith Erlen, University of Pittsburgh:
Cognitive Impairment
Memory loss
Caregivers
Medication adherence
Medication compliance
 Medication management
Problem solving
Quality of Life
Health resource utilization
Community dwelling