Mild Cognitive Impairment
Conditions
Keywords
Mild cognitive impairment, Quality of life, Family caregivers
Brief summary
The investigators developed and tested the Daily Engagement in Meaningful Activities (DEMA) intervention to improve life satisfaction and health outcomes for patients and caregivers. DEMA is a positive health focused, theoretically grounded, tailored, family-centered, multi-faceted intervention. Over 7 session, dyads work with a nurse to 1) identify meaningful activities, assess capacity, problem-solve barriers, and establish routines for engagement and 2) learn more about MCI by working through six Self-Management Toolkit topics (e.g., benefits of meaningful activity; planning the future). The investigators' purpose is to evaluate the efficacy of DEMA in a two-group randomized controlled trial with 210 patient/caregiver dyads (DEMA intervention vs. the information support (IS) attention control group).
Detailed description
Approximately 20% of Americans over 65 have mild cognitive impairment (MCI), defined as experiencing more memory problems than normally expected with aging, but no other symptoms of dementia such as impaired judgment or reasoning. Persons with MCI (patients) are at great risk for developing dementia (10-33% per year). Memory problem (poor executive function) diminish the patient's confidence and ability to perform meaningful and/or important activities (e.g. socialization, medication management). Deteriorating life satisfaction in patients and care partners (caregivers) is a prevalent problem due to diminished meaningful activity engagement which occurs as a result of patient frustration and embarrassment, lack of self-efficacy (confidence), and diminishing activity performance. As a result, patients experience additional negative health outcomes: 38% report depressive symptoms and anxiety. Caregivers often lack confidence to manage their own and the patient's daily challenges and meaningful activity engagement, leading to high caregiver burden, depressive symptoms, and anxiety. As a dyad, both patients and caregivers report diminished satisfaction within their communication and relationship due to disagreement about the patient's functional ability to effectively and safely perform meaningful activities. Emerging evidence indicates regular engagement in social, physical or cognitive activities can improve life satisfaction, activity performance, depressive symptoms, anxiety, and dyad communication; health outcomes are even better when the activities are self-selected and meaningful. To promote patients' and caregivers' life satisfaction and health outcomes, interventions to maximize patients' capacity for full engagement in meaningful activities are essential; yet, there is a marked absence of such empirically validated interventions. The investigators' purpose is to evaluate the efficacy of DEMA in a two-group randomized controlled trial with 210 patient/caregiver dyads (DEMA intervention vs. the information support (IS) attention control group). 2.0 Rationale and Specific Aims. Aim 1 (Primary Objective): To test DEMA's efficacy for improving life satisfaction in patients and their caregivers over time compared to the IS group. Mixed effects model will be used to compare repeated Life Satisfaction Index for the Third Age (LSITA) Scale-Short Form at pre-intervention evaluation (T1) and post-intervention evaluations (14 days, 3- and 6-months). Aim 2 (Secondary): Over time, evaluate DEMA's efficacy for patient and caregiver to: 1. increase patient activity performance and diminish depressive symptoms and anxiety compared to the IS group. 2. decrease caregivers burden, depressive symptoms, and anxiety compared to the IS group. Using mixed effects models to compare repeated PHQ-9 questionaires, GAD-7, ADCS-MCI-ADL Scale, Relationship Assessment Scale (RAS) And Caregiving outcomes scale (COS), at pre-intervention evaluation (T1) and post-intervention evaluations (14 days, 3- and 6-months). Aim 3: Explore improvement in health outcomes over time in the sub-sample of patients with depressive symptoms using the (PHQ)-9 ≥ 5 at baseline) and explore the burden on caregivers when patients have PHQ-9 is \>5. Compared to the non-depressed participants: Patients with depressive symptoms (scores \> 5 on PHQ-9 measured at baseline) will have improved activity performance. Caregivers of patients with depressed symptoms (scores \> 5 on PHQ-9 measured at baseline) will report reduced burden. and Patients with depressive symptoms (scores \> 5 on PHQ-9 measured at baseline) and their caregivers randomized to DEMA will report improved: confidence to manage daily challenges, communication satisfaction, life satisfaction, relationship satisfaction, decreased depressive symptoms and anxiety using pre-specific outcomes measures including but not limited to: confidence scale, The subscale of Communication and Affective Responsiveness (CAR), Dementia Deficits Scale (DDS) (Patient vs. Caregiver Versions), The Canadian Occupational Performance Measure (COPM), The modified Credibility/Expectancy Questionnaire (CEQ).
Interventions
BEHAVIORALDaily Engagement Meaningful Activity (DEMA)
This group will receive 7 individualized sessions, 1 face-to-face session at week 1 and via 6 bi weekly telephone sessions delivered by a trained intervener. DEMA will use the principles of problem-solving therapy and consistent with the overall goals of this intervention; and will provide autonomy support, 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. Each session consists: 1) MCI dyads are guided to use the principles of problem-solving therapy to review their personalized, self-selected meaningful activities and plan next steps to continue the activity, identify and establish a plan for additional activities; and 2) the intervener and dyad discuss one of the 6 topics in the Toolkit such as introducing of the intervention and meaningful activity concepts, understanding MCI, its treatments, management, resources, and planning for the future.
BEHAVIORALInformation Support (IS)
This group will attend 1 face-to-face meetings to receive an overview of what will happen in the study and an initial Alzheimer disease educational brochure from the Alzheimer's Association (AA). The face-to-face sessions will take place at the IADC Clinical Core clinic, Indiana University Center of Excellence of Women's Health clinic, or Indiana School of Nursing conference room that based on patient-caregiver dyad's preference. Then they will receive 6 bi weekly follow-up phone calls and have the opportunity to ask only questions related to the educational materials. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
Sponsors
Indiana University
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Following consent, the project manager will arrange a time convenient for patient-caregiver dyads to separately complete the baseline (T1) measures by phone. A data collector, blinded to randomization status, will administer all measures at all time points via phone interviews in a quiet, private setting and be available for questions following data collection. Immediately following completion of the T1 measures; and enter patient scores on the PHQ-9 depression scale directly to the database. A web-based computer-generated stratified randomization scheme will be used to assign the patient-caregiver dyads to DEMA or the information support group in 1:1 ratio using a block-randomized approach stratified on a depression score PHQ-9 ≤ 4 vs. PHQ-9 ≥ 5 or higher will be used to determine the randomization scheme. The Project Manager will immediately schedule Session 1. Only the statistician, PI, project manager, and the intervener will know the patient-caregiver dyad's randomization status.
Intervention model description
The study conceptual framework is based on: 1) pilot work, 2) the Canadian Model of Occupational Performance that describes how individuals are motivated, adjust to psychosocial context and cognitive decline, and choose to participate in essential and meaningful daily activities; 3) problem-solving therapy principles. These frameworks, commonly applied to health problems in older populations, provide a systematic structure to improve task initiation and completion in adults with depression or executive dysfunction.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
MCI Patient * age greater than 59 years old * able to speak and read English * access to telephone * have both self or informant reported cognitive complaints * MoCA score = 15 to 25 * in the normal range in performance of daily living tasks based on functional impairment absent: a check box of Functional Activities Questionnaire (FAQ) has no score ≥2); Inclusion Criteria: Family caregivers: * self-identify as care partner (i.e. spouse, family member or friend) * aged greater than or equal to 18 years * have primary responsibility for providing care to an MCI patient, along with monitoring safety and providing social support; * are able to speak and read English; * access to telephone * oriented to persons, places, and time (having a 6-item Screener score of 4 or above).
Exclusion criteria
* a diagnosed untreated severe major depression, or receiving advanced cancer treatment or hospice care * receiving dialysis * severe hearing loss and no hearing aids * have no access to a telephone * the family caregiver has significant cognitive impairment that may hinder participation (6-item MMSE \< 4).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Life Satisfaction (LSITA) | Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation | The Life Satisfaction Index for the Third Age (LSITA) Scale-Short Form, is a 12-item with a 6-point response scale (ranging from "1" Strongly disagree to "6" strongly agree) (Barrett \& Murk, 2006). It is a measure of the overall construct of Life Satisfaction. It has been commonly used in older populations. Possible range of total scores is 12-72 and higher scores indicate better functioning. The total score ranges from 12 to 72.The reliability of the LSITA-SF scale was .90 (Barrett \& Murk, 2006). The scale takes about 3 minutes to complete it. The LSITA is completed by patient and caregiver separately. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 Items (PHQ-9) | Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation | Patient Health Questionnaire-9 Items (PHQ-9) is used to measure emotional function (Kroenke, Spitzer, \& Williams, 2001). The PHQ-9 contains nine questions about symptoms. It has been widely used in older populations. The depression severity levels are: The scores 0 -4 indicate none, the scores between 5 to 9 indicate mild depression; the score between 10-14 indicates moderate depression; the scores between 15 to 19 indicate moderately severe depression, the scores between 20 to 27 indicate severe depression. The internal reliability was 0.83 to 0.92 (Kroenke et al., 2001). The scale takes about 3 minutes to complete it. The PHQ-9 is completed by patient and caregiver separately.Total scores range from 0 to 27, with higher scores indicating increased severity. |
| The General Anxiety Disorder 7-item (GAD-7) | Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation | The General Anxiety Disorder 7-item (GAD-7), four-point Liker scale is used to measure emotional function and it contains 7 questions about anxiety (Spitzer, Kroenke, Williams, \& Lowe, 2006). It has been widely used in older populations. The GAD-7 scale score ranges from 0 to 21 and high scores indicates perceiving high level of anxiety. The internal reliability was 0.92 and test-retest reliability was 0.83 (Spitzer et al., 2006). The scale takes about 3 minutes to complete it. The GAD-7is completed by patient and caregiver separately. |
| Alzheimer Disease Cooperative Study MCI-Activities of Daily Living Inventory [ADCS-MCI-ADL Scale] | Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation | The 23-item ADCS-MCI-ADL Scale has good test-retest reliability, will be utilized to assess performance functioning in MCI patients (Galasko et al., 1997; Douglas Galasko et al., 2006; Pedrosa et al., 2010). The ADCS-ADL includes 18 items from traditional basic ADL scales and 5 items from instrumental activities of daily living scales (IADL) The possible range of total scores for the ADL Scale is 0-53 and higher scores indicate better functioning. The internal reliability was .91( Galasko et al., 1997; Douglas Galasko et al., 2006; Pedrosa et al., 2010). The scale takes about 15 minutes to complete it. |
| Relationship Assessment Scale (RAS) | Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation | The Relationship Assessment Scale is a 7-item, 5 points Likert scale designed to measure general relationship satisfaction (Graham, Kunik, Doody, \& Snow, 2005). The RAS was produces more reliable scores when administered to older individuals, older relationship, and married couples but it was intended to be applicable to a wide range of relationship types (Graham et al., 2005). Respondents answer each item using a 5-point scale ranging from 1 (low satisfaction) to 5 (high satisfaction). Total scores range from 7 to 35, with higher scores indicating better relationship satisfaction. The internal reliability was .86-.87. The scale takes about 3 minutes to complete it. |
| Caregiving Outcomes Scale (COS) | Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation | The Bakas Caregiving Outcomes Scale (COS), a 15-item with a 7-point scale, self-report inventory, will be utilized to assess family caregiver outcomes. The scale has been used in family caregivers of those with a variety of other chronic conditions (Bakas, Champion, Perkins, Farran, \& Williams, 2006; Pressler, 2008). It is one of recommendation instruments that can be used to identify priority areas for nursing intervention designed to improve caregivers' outcomes (Bakas et al., 2006; Deeken, Taylor, Mangran, Yabroff, \& Ingham, 2003). The 15 Bakas COS items and the validity item are rated on a 7-point scale ranging from -3 (changed for the worst) to + 3 (changed for the best). The -3 to +3 ratings are recoded to 1 to 7, so positive numbers can be obtained for analysis. The COS total scores of range from 15 to 105, with higher score indicating more positive caregiver outcomes. The internal consistency reliability was provided alpha = .90 (Bakas et al., 2006). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYvonne Y Lu, PhD
Indiana University
Participant flow
Recruitment details
Initial study approval was January 20th 2021. However, recruitment approaches transitioned from in-person approach to over the telephone due to COVID-19 and competing studies. Recruitment began 12/13/2021 and ended on 7/18/2025. Recruitment locations included in-clinic referrals, healthcare service databases, community organization partnerships, volunteer participant registries, among others.
Pre-assignment details
Before randomization and baseline data collection, a total of 22 enrolled and consented participants (11 patient-caregiver dyads) withdrew from the study. Reasons: did not wish to continue (n=9), lost to follow-up (n=1), and other (n=1).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 69.1 years STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 98 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Patient Montreal Cognitive Assessment (MoCA)[1] | 21.3 score on a scale STANDARD_DEVIATION 3.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 87 Participants |
| Region of Enrollment United States | 99 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 100 | 2 / 99 |
| other Total, other adverse events | 0 / 100 | 0 / 99 |
| serious Total, serious adverse events | 3 / 100 | 3 / 99 |
Outcome results
None listed