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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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.
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- 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
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.
- Conditions
- Mild Cognitive Impairment
- 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 group | Role | What they receive |
|---|---|---|
| Daily Enhancement Meaningful Activity (DEMA) | Experimental | The 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 comparator | The 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.
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)
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
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
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
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
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
Patient_Sense of confidence: Confidence Scale
Measured: Change in sense of confidence from baseline to immediately (two-week)- and 3 months- post program
Caregiver_Depressive Symptoms: PHQ-9
Measured: Change in depressive symptoms from baseline to immediately (two-week)- and 3 months post-program evaluation
Caregiver_ Caregiver life changes: Caregiving Outcomes Scale
Measured: Change in caregivign outcomes from baseline to immediately (two-week)- and 3 months post-post program
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.
- First posted30 Apr 2013 (estimated)
- Study startJul 2012
- Primary completionMar 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yvonne Lu, PhD, Principal investigator, IU School of Nursing
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meaningful Activity Intervention for Persons With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT01843283
- Acronym / sponsor ID
- 1R21NR013755-01
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Family Caregivers, Intervention studies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 30 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily Enhancement Meaningful Activity (DEMA) | Experimental | Behavioral: Daily Enhancement Meaningful Activity (DEMA)The 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. |
| Information Support (IS) | Active comparator | Behavioral: Information Support (IS)The 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. |
Who may qualify
- Ages
- 21 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily Enhancement Meaningful Activity (DEMA) | Behavioural | Daily Enhancement Meaningful Activity (DEMA) |
| Information Support (IS) | Behavioural | Information Support (IS) |
Primary outcome
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
9 secondary outcomes
Patient_satisfaction with communication: The subscale of Communication and Affective Responsiveness
Time frame: Change in satisfaction with communication from baseline to immediately (two-week)- and 3 months post-intervention
Patient_Physical Function: Alzheimer disease cooperative study activities of daily living inventory.
Time frame: Change in physical function from baseline to immediately (two-week)- and 3 months post-intervention
Patient_Life satisfaction : Life Satisfaction Index for the Third Age-Short Form
Time frame: Change in life satisfaction from baseline to immediately (two-week)- and 3 months post-intervention
Patient_Satisfaction with program: Satisfaction with Meaningful Activity Program Scale is adapted from the Caregiver Satisfaction Scale
Time frame: It will be collected at 3 months post-program evaluation
Patient_ Meaningful activities engagement performance and satisfaction: Canadian Occupational Performance Measure & weekly log
Time frame: Change in meaningful activities engagement performance and satisfactionfrom baseline to immediately (two-weeks)- and 3 months post-intervention
Patient_Sense of confidence: Confidence Scale
Time frame: Change in sense of confidence from baseline to immediately (two-week)- and 3 months- post program
Caregiver_Depressive Symptoms: PHQ-9
Time frame: Change in depressive symptoms from baseline to immediately (two-week)- and 3 months post-program evaluation
Caregiver_ Caregiver life changes: Caregiving Outcomes Scale
Time frame: Change in caregivign outcomes from baseline to immediately (two-week)- and 3 months post-post program
Caregiver_- Satisfaction with program: Satisfaction with Meaningful Activity Program Scale is adapted from the Caregiver Satisfaction Scale
Time frame: It will be assessed at 3 months post-program evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Lu, PhD principal investigator
IU School of Nursing
1 site in 1 country: see every site and its status.
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.