Medication Collaboration Feasibility Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorNorthwestern University
About this trial
This study examines the feasibility and acceptability of a brief medication collaboration intervention among older adults (age 60+) with early-stage dementia or mild cognitive impairment who take multiple medications and their family caregivers. The main aims are to: 1) determine the feasibility and acceptability of the intervention for older adults with early-stage dementia and their family caregivers, and 2) explore the effects of intervention on medication collaboration, medication adherence, and beliefs about dementia and autonomy.
In this study, participants will: 1) complete a 15-30-minute baseline interview (by Zoom or phone), 2) participate together in a 45-60-minute virtual intervention led by an interventionist that includes:
Assessment of medication responsibilities and beliefs. Education about dementia and medication management. Cognitive restructuring to address beliefs about independence and caregiver assistance.
Collaborative planning for medication responsibilities and routines; and lastly 3) complete a 15-20-minute one-month follow-up interview (by Zoom or phone) to assess the intervention's acceptability and changes in medication management outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 60 or older
Diagnosis of dementia, Alzhimer's Disease or Mild Cognitive Impairment
Quick Dementia Rating Scale Score 2-12 (inclusive of mild cognitive impairment and mild dementia)
Taking 3 or more medications
Disqualifiers
adults unable to consent
Trial design
Design model
Single group
Treatments tested in this trial
Medication Collaboration Intervention
BehavioralA brief virtual behavioral intervention for older adults with early-stage dementia and their family caregivers designed to support collaborative medication management. The intervention includes: (1) assessment of beliefs about dementia, autonomy, and current medication responsibilities; (2) education on dementia progression and medication management; (3) reframing maladaptive beliefs regarding independence and caregiver assistance; and (4) collaborative development of implementation intentions and medication responsibility plans to facilitate medication adherence and the transition of medication management responsibilities. The intervention is delivered remotely via Zoom or telephone in a single 45-60-minute session by trained study interventionists.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Medication Collaboration InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acceptability of the Medication Collaboration Intervention
Participant-reported acceptability of the intervention will be measured using The Acceptability of Intervention Measure, Intervention Appropriateness Measure, and Feasibility of Intervention Measure. Scale values range from 1 to 5 with a higher score indicating greater perceived acceptability of the Medication Collaboration Intervention.
Time frame
1 MonthSecondary outcomes
1
Medication Collaboration
Self-report of caregiver involvement with medications will be measured using an adapted version of the dyadic relationship scale. Scale scores range from 1-5 with a higher score indicating higher medication collaboration between caregiver and patient.
Time frame
1 Month2
Medication adherence
Self-reported medication adherence via the Medication Adherence Scale. Responses are summed and averaged, with total scores ranging from 0-5, and higher scores indicating better adherence.
Time frame
1 Month3
Beliefs about dementia
Beliefs about dementia will be measured using the Representations and Adjustment to Dementia Index (RADIX) questionnaire. Individual items are scored, and scores range from 1-4.
Time frame
1 month4
Medication Administration Hassles
Caregiver reported medication administration hassles will be measured using The Family Caregiver Medication Administration Hassles Scale. We will use the Logistics subscale. The total score ranges from 0-35, with higher scores indicating greater perceived hassle associated with managing the logistics of another person's medication regimen
Time frame
1 MonthSponsors and contacts
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Source ClinicalTrials.gov