Improving Caregiver Mediated Medication Management- The 3M Study

NCT ID: NCT03127930

Last Updated: 2017-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-01
• Study Completion Date: 2013-07-30

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.

Conditions

Medication Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intervention

Intervention Type: BEHAVIORAL

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.

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. .

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Problem Solving training to improve medication management

Eligibility 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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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Judith Erlen

Professor of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Judith A Erlen, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

References

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.

Reference Type: RESULT

PMID: 23445184 (View on PubMed)

Lingler 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.

Reference Type: RESULT

PMID: 26804450 (View on PubMed)

Tang 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.

Reference Type: RESULT

PMID: 26317766 (View on PubMed)

Other Identifiers

PRO08050015

Identifier Type: -

Identifier Source: org_study_id