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Mild Cognitive ImpairmentPhase 1NCT01843283

Meaningful Activity Intervention for Persons With Mild Cognitive Impairment

A Phase 1 study testing Daily Enhancement Meaningful Activity (DEMA) and Information Support (IS) in people with Mild Cognitive Impairment, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this pilot study is to evaluate the feasibility of and satisfaction with the revised DEMA and to estimate effect sizes for DEMA through incorporation of a comparison group. Specific aims are as follows: Aim 1: Evaluate feasibility of the study for MCI patient/caregivers. Read more about this study

Who is it for?
Ages 21 to 95 yearsHealthy volunteers can take part
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Daily Enhancement Meaningful Activity (DEMA) and Information Support (IS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
Jul 2012to May 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 95 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • MCI patients:
  • are aged 60 years or older,
  • speak English,
  • have both caregiver-reported, clinically significant decline in cognition and clinician-detected or research based cognitive impairment on the standardized health exam
  • have at least one cognitive assessment score below the 7th percentile
  • have a normal range in performance of daily living tasks based on informant interview information indicating that impairment does not rise to the level of dementia.
Show all 11Show fewer
  • Family caregivers:
  • are adults ≥ 21 years of age;
  • have primary responsibility for providing unpaid care to an MCI relative, along with monitoring safety and providing social support
  • are able to read and speak English
  • are oriented to persons, places, and time [having a 6-item Mini-Mental State Examination (MMSE) score of 4 or above]

Who cannot join

  • MCI patients and family caregivers will be excluded if:
  • the MCI patient or family caregiver has a diagnosed bipolar disorder or untreated schizophrenia;
  • the family caregiver has significant cognitive impairment that may hinder participation (6-item MMSE < 4)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Indiana University School of Nursing

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

The purpose of this pilot study is to evaluate the feasibility of and satisfaction with the revised DEMA and to estimate effect sizes for DEMA through incorporation of a comparison group. Specific aims are as follows:

Aim 1: Evaluate feasibility of the study for MCI patient/caregivers. Aim 2: Estimate effect sizes for DEMA on MCI patient and caregiver outcomes. Aim 3: Evaluate MCI patients and family caregivers' satisfaction with and perceptions of DEMA or IS.

Read the detailed description

Mild cognitive impairment (MCI) affects as many as 20% of older adults who are at a greater risk of developing Alzheimer's disease (AD). MCI involves functional decline that may include decrements in engagement in meaningful activities and one's own sense of confidence/mastery, and it is associated with depressive symptoms, poor satisfaction with family communication, and declining physical function. Existing interventions for MCI patients and caregivers often focus on a single problem, such as memory or physical activity and there are no available multi-faceted supportive care interventions to meet the needs of the MCI patients and their caregivers in order to prevent premature disengagement and risk for depressive symptoms. The Daily Enhancement of Meaningful Activity (DEMA) intervention uses a family dyadic, strengths-based, and positive health approach that builds on existing dyadic skills and values to accomplish meaningful activity engagement to address the priority needs for efficacious interventions to prevent premature disengagement and depressive symptoms in MCI patients. The DEMA builds on the investigators' previous descriptive work and gerontology theory, the model human occupation, and components of the Problem-Solving Therapy. The investigators' preliminary findings showed that the intervention and measures were acceptable, and suggestions were solicited from the participants for improving delivery. The purpose of this pilot study is to 1) evaluate the feasibility and satisfaction of the revised DEMA intervention; and 2) estimate effect sizes for the intervention through the incorporation of a comparison group. The MCI-caregiver dyads (n = 36 dyads) will be randomized to the DEMA or informational support groups; each group will receive 6 bi-weekly sessions (2 face-to-face and 4-phone delivered) with a trained intervener. The data from MCI patients and caregivers outcomes will be collected at pre-intervention, immediately (two weeks) post-intervention, and 3 months post-program evaluation. Descriptive statistics analysis will be used for satisfaction with and perception of the DEMA or informational support groups and general linear mixed models will be used to estimate the effect sizes of the intervention on the proximal and distal outcomes. Findings will inform the design of a subsequent R01 to: 1) test the efficacy of DEMA for MCI patient-caregiver dyads in a longitudinal randomized clinical trial; and 2) explore the costs/benefits of implementation. If it is found to be efficacious, DEMA has the potential to slow the rate of disability progression from MCI to AD and improve quality of life outcomes for patients and caregivers.

Being tested
Daily Enhancement Meaningful Activity (DEMA), Information Support (IS)
Keywords
Mild Cognitive Impairment, Family Caregivers, Intervention studies
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Daily Enhancement Meaningful Activity (DEMA)Behavioural

  • Information Support (IS)Behavioural

Study groups in NCT01843283
Study groupRoleWhat they receive
Daily Enhancement Meaningful Activity (DEMA)ExperimentalThe group member will receive Self-management Toolkit and 6 bi-weekly individualized sessions, 2 face-to-face and 4 via telephone delivered by a trained intervener. DEMA will provide autonomy support by helping patients to identify and prioritize activities, classify needs and goals, generalize manageable solutions, engage in self-selected activities under family support, and self-evaluate failure and success or renew problem-solving as needed.
Receives: Behavioral: Daily Enhancement Meaningful Activity (DEMA)
Information Support (IS)Active comparatorThe IS group will receive 2 face-to-face meetings to receive an overview of what will happen in the study and an initial Alzheimer Association, educational brochure. Then they will receive 4 biweekly follow-up phone calls and have the opportunity to ask only questions related to the educational materials.
Receives: Behavioral: Information Support (IS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient_Depression symptoms: Patient Health Questionnaire Depression Scale (PHQ-9)

    Measured: Change in depression from baseline to immediately (two-week)- and 3 months post-intervention

Secondary outcomes (9)
  1. Patient_satisfaction with communication: The subscale of Communication and Affective Responsiveness

    Measured: Change in satisfaction with communication from baseline to immediately (two-week)- and 3 months post-intervention

  2. Patient_Physical Function: Alzheimer disease cooperative study activities of daily living inventory.

    Measured: Change in physical function from baseline to immediately (two-week)- and 3 months post-intervention

  3. Patient_Life satisfaction : Life Satisfaction Index for the Third Age-Short Form

    Measured: Change in life satisfaction from baseline to immediately (two-week)- and 3 months post-intervention

  4. Patient_Satisfaction with program: Satisfaction with Meaningful Activity Program Scale is adapted from the Caregiver Satisfaction Scale

    Measured: It will be collected at 3 months post-program evaluation

  5. Patient_ Meaningful activities engagement performance and satisfaction: Canadian Occupational Performance Measure & weekly log

    Measured: Change in meaningful activities engagement performance and satisfactionfrom baseline to immediately (two-weeks)- and 3 months post-intervention

  6. Patient_Sense of confidence: Confidence Scale

    Measured: Change in sense of confidence from baseline to immediately (two-week)- and 3 months- post program

  7. Caregiver_Depressive Symptoms: PHQ-9

    Measured: Change in depressive symptoms from baseline to immediately (two-week)- and 3 months post-program evaluation

  8. Caregiver_ Caregiver life changes: Caregiving Outcomes Scale

    Measured: Change in caregivign outcomes from baseline to immediately (two-week)- and 3 months post-post program

  9. Caregiver_- Satisfaction with program: Satisfaction with Meaningful Activity Program Scale is adapted from the Caregiver Satisfaction Scale

    Measured: It will be assessed at 3 months post-program evaluation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2013 (estimated)
  2. Study startJul 2012
  3. Primary completionMar 2015
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01843283
Sponsor's protocol ID
1R21NR013755-01
Status last verified
Oct 2016
First submitted
26 Apr 2013
Last updated
25 Oct 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Daily Enhancement Meaningful Activity (DEMA) and Information Support (IS) in people with Mild Cognitive Impairment, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient_Depression symptoms: Patient Health Questionnaire Depression Scale (PHQ-9) (time frame: Change in depression from baseline to immediately (two-week)- and 3 months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.

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