Improving Caregiver Mediated Medication Management- The 3M Study

NCT03127930 | Completed DMC

• 1 other identifier: PRO08050015
• Study Type: interventional
• Target: 183
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (3)

• Medication management assessed by investigator developed Medication Deficiency Checklist- post-treatment

  Improved medication management of patient's medications by caregiver at post-intervention.

  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

  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.

  24 weeks

Secondary Outcomes (2)

• Patient outcomes- medical utilization-Investigator developed Unscheduled Event Checklist

  24 weeks

• Caregiver outcome- Improved quality of life via Medical Outcome Short Form (SF-36)

  24 weeks

Study Arms (2)

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.

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. .

Interventions

Intervention 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.

Also known as: Problem Solving training to improve medication management

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Related Publications (3)

• 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.

  PMID: 23445184 RESULT

• 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.

  PMID: 26804450 RESULT

• 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.

  PMID: 26317766 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction; Memory Disorders; Medication Adherence

Interventions

Methods

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Judith A Erlen, RN, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Participants and outcomes assessors were not blind to the intervention by nature o the protocol. Investigators and analysts were blinded to study group assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nursing

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 25, 2017
• Study Start: June 1, 2010
• Primary Completion: July 30, 2013
• Study Completion: July 30, 2013
• Last Updated: May 4, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share