Clinical Trial: Improving Caregiver Mediated Medication Management- The 3M Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Improving Caregiver Mediated Medication Management

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 Summary:

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 deficienci
    Sponsor: University of Pittsburgh

    Current 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.


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

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


    Original Secondary Outcome: Same as current

    Information By: University of Pittsburgh

    Dates:
    Date Received: April 18, 2017
    Date Started: June 1, 2010
    Date Completion:
    Last Updated: May 1, 2017
    Last Verified: May 2017