Mild Cognitive ImpairmentPRIMANCT04515875
PRIMA Intervention for Adults With Mild Cognitive Impairment and Their Caregivers
A study testing Daily Engagement 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 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Daily Engagement Meaningful Activity (DEMA) and Information Support (IS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2021to 20 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Show all 12Show fewer
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Alzhemier Disease Research Center
Indianapolis, Indiana, 46202
About this study
Official title: Promoting Reengagement in Daily Meaningful Activity (PRIMA) Intervention for Adults With Mild Cognitive Impairment and Their Caregivers
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).
Read the 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:
- increase patient activity performance and diminish depressive symptoms and anxiety compared to the IS group.
- 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).
- Conditions
- Mild Cognitive Impairment
- Being tested
- Daily Engagement Meaningful Activity (DEMA), Information Support (IS)
- Keywords
- Mild cognitive impairment, Quality of life, Family caregivers
- 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 Engagement Meaningful Activity (DEMA)Behavioural
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.
Information Support (IS)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Daily Engagement Meaningful Activity (DEMA) | Experimental | This group will receive 7 telephone sessions over a 12 week period (1st session week, 2-7 bi-weekly) 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. Receives: Behavioral: Daily Engagement Meaningful Activity (DEMA) |
| Information Support (IS) | Placebo comparator | This group will attend 7 telephone sessions to receive an overview of what will happen in the study and use selected educational material from the Alzheimer's Association delivered by a trained intervener. The sessions will occur over 12 weeks (1 session at Week 1, bi-weekly from the 2 to 7 sessions) via phone calls. Dyads will 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. Receives: Behavioral: Information Support (IS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life Satisfaction (LSITA)
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.
Measured: Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation
Secondary outcomes (5)
Patient Health Questionnaire-9 Items (PHQ-9)
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.
Measured: 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)
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.
Measured: Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation
Alzheimer Disease Cooperative Study MCI-Activities of Daily Living Inventory [ADCS-MCI-ADL Scale]
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.
Measured: Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation
Relationship Assessment Scale (RAS)
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.
Measured: Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation
Caregiving Outcomes Scale (COS)
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).
Measured: Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start13 Dec 2021
- Primary completion20 Jul 2025
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (22)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Yvonne Lu, Indiana University
- Investigators
- Yvonne Y Lu, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515875
- Sponsor's protocol ID
- IUPREMA0822
- Other IDs
- 1R01NR018162-01A1
- Acronym
- PRIMA
- Status last verified
- Dec 2025
- First submitted
- 15 Jun 2020
- Last updated
- 15 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Roberts JL, Clare L. Meta-representational awareness in mild cognitive impairment: an interpretative phenomenological analysis. Aging Ment Health. 2013;17(3):300-9. doi: 10.1080/13607863.2012.732033. Epub 2012 Oct 16.
PubMed 23072638Plassman BL, Langa KM, McCammon RJ, Fisher GG, Potter GG, Burke JR, Steffens DC, Foster NL, Giordani B, Unverzagt FW, Welsh-Bohmer KA, Heeringa SG, Weir DR, Wallace RB. Incidence of dementia and cognitive impairment, not dementia in the United States. Ann Neurol. 2011 Sep;70(3):418-26. doi: 10.1002/ana.22362. Epub 2011 Mar 18.
PubMed 21425187Ward A, Tardiff S, Dye C, Arrighi HM. Rate of conversion from prodromal Alzheimer's disease to Alzheimer's dementia: a systematic review of the literature. Dement Geriatr Cogn Dis Extra. 2013 Sep 28;3(1):320-32. doi: 10.1159/000354370. eCollection 2013.
PubMed 24174927Apostolova LG, Cummings JL. Neuropsychiatric manifestations in mild cognitive impairment: a systematic review of the literature. Dement Geriatr Cogn Disord. 2008;25(2):115-26. doi: 10.1159/000112509. Epub 2007 Dec 14.
PubMed 18087152Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Pedrosa H, De Sa A, Guerreiro M, Maroco J, Simoes MR, Galasko D, de Mendonca A. Functional evaluation distinguishes MCI patients from healthy elderly people--the ADCS/MCI/ADL scale. J Nutr Health Aging. 2010 Oct;14(8):703-9. doi: 10.1007/s12603-010-0102-1.
PubMed 20922349Galasko D, Bennett D, Sano M, Ernesto C, Thomas R, Grundman M, Ferris S. An inventory to assess activities of daily living for clinical trials in Alzheimer's disease. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord. 1997;11 Suppl 2:S33-9.
PubMed 9236950Galasko D, Bennett DA, Sano M, Marson D, Kaye J, Edland SD; Alzheimer's Disease Cooperative Study. ADCS Prevention Instrument Project: assessment of instrumental activities of daily living for community-dwelling elderly individuals in dementia prevention clinical trials. Alzheimer Dis Assoc Disord. 2006 Oct-Dec;20(4 Suppl 3):S152-69. doi: 10.1097/01.wad.0000213873.25053.2b.
PubMed 17135809Graham DP, Kunik ME, Doody R, Snow AL. Self-reported awareness of performance in dementia. Brain Res Cogn Brain Res. 2005 Sep;25(1):144-52. doi: 10.1016/j.cogbrainres.2005.05.001.
PubMed 15919186Bakas T, Champion V, Perkins SM, Farran CJ, Williams LS. Psychometric testing of the revised 15-item Bakas Caregiving Outcomes Scale. Nurs Res. 2006 Sep-Oct;55(5):346-55. doi: 10.1097/00006199-200609000-00007.
PubMed 16980835Pressler SJ. Cognitive functioning and chronic heart failure: a review of the literature (2002-July 2007). J Cardiovasc Nurs. 2008 May-Jun;23(3):239-49. doi: 10.1097/01.JCN.0000305096.09710.ec.
PubMed 18437066Deeken JF, Taylor KL, Mangan P, Yabroff KR, Ingham JM. Care for the caregivers: a review of self-report instruments developed to measure the burden, needs, and quality of life of informal caregivers. J Pain Symptom Manage. 2003 Oct;26(4):922-53. doi: 10.1016/s0885-3924(03)00327-0.
PubMed 14527761Nowotny ML. Assessment of hope in patients with cancer: development of an instrument. Oncol Nurs Forum. 1989 Jan-Feb;16(1):57-61.
PubMed 2911528Snow AL, Norris MP, Doody R, Molinari VA, Orengo CA, Kunik ME. Dementia Deficits Scale. Rating self-awareness of deficits. Alzheimer Dis Assoc Disord. 2004 Jan-Mar;18(1):22-31. doi: 10.1097/00002093-200401000-00005.
PubMed 15198084
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Reengagement in Daily Meaningful Activity (PRIMA) Intervention for Adults With Mild Cognitive Impairment and Their Caregivers
- ClinicalTrials.gov ID
- NCT04515875
- Acronym / sponsor ID
- PRIMA / IUPREMA0822
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild cognitive impairment, Quality of life, Family caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Posted 15 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- increase patient activity performance and diminish depressive symptoms and anxiety compared to the IS group.
- 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Daily Engagement Meaningful Activity (DEMA) | Experimental | Behavioral: Daily Engagement Meaningful Activity (DEMA)This group will receive 7 telephone sessions over a 12 week period (1st session week, 2-7 bi-weekly) 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. |
| Information Support (IS) | Placebo comparator | Behavioral: Information Support (IS)This group will attend 7 telephone sessions to receive an overview of what will happen in the study and use selected educational material from the Alzheimer's Association delivered by a trained intervener. The sessions will occur over 12 weeks (1 session at Week 1, bi-weekly from the 2 to 7 sessions) via phone calls. Dyads will 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
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 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. | Behavioural | Daily Engagement Meaningful Activity (DEMA) |
| Information 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. | Behavioural | Information Support (IS) |
Primary outcome
Life Satisfaction (LSITA)
Time frame: 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.
5 secondary outcomes
Patient Health Questionnaire-9 Items (PHQ-9)
Time frame: 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)
Time frame: Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation
Alzheimer Disease Cooperative Study MCI-Activities of Daily Living Inventory [ADCS-MCI-ADL Scale]
Time frame: Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation
Relationship Assessment Scale (RAS)
Time frame: Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation
Caregiving Outcomes Scale (COS)
Time frame: Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23072638Roberts JL, Clare L. Meta-representational awareness in mild cognitive impairment: an interpretative phenomenological analysis. Aging Ment Health. 2013;17(3):300-9. doi: 10.1080/13607863.2012.732033. Epub 2012 Oct 16.
- Background: PubMed 21425187Plassman BL, Langa KM, McCammon RJ, Fisher GG, Potter GG, Burke JR, Steffens DC, Foster NL, Giordani B, Unverzagt FW, Welsh-Bohmer KA, Heeringa SG, Weir DR, Wallace RB. Incidence of dementia and cognitive impairment, not dementia in the United States. Ann Neurol. 2011 Sep;70(3):418-26. doi: 10.1002/ana.22362. Epub 2011 Mar 18.
- Background: PubMed 24174927Ward A, Tardiff S, Dye C, Arrighi HM. Rate of conversion from prodromal Alzheimer's disease to Alzheimer's dementia: a systematic review of the literature. Dement Geriatr Cogn Dis Extra. 2013 Sep 28;3(1):320-32. doi: 10.1159/000354370. eCollection 2013.
- Background: PubMed 18087152Apostolova LG, Cummings JL. Neuropsychiatric manifestations in mild cognitive impairment: a systematic review of the literature. Dement Geriatr Cogn Disord. 2008;25(2):115-26. doi: 10.1159/000112509. Epub 2007 Dec 14.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 20922349Pedrosa H, De Sa A, Guerreiro M, Maroco J, Simoes MR, Galasko D, de Mendonca A. Functional evaluation distinguishes MCI patients from healthy elderly people--the ADCS/MCI/ADL scale. J Nutr Health Aging. 2010 Oct;14(8):703-9. doi: 10.1007/s12603-010-0102-1.
- Background: PubMed 9236950Galasko D, Bennett D, Sano M, Ernesto C, Thomas R, Grundman M, Ferris S. An inventory to assess activities of daily living for clinical trials in Alzheimer's disease. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord. 1997;11 Suppl 2:S33-9.
- Background: PubMed 17135809Galasko D, Bennett DA, Sano M, Marson D, Kaye J, Edland SD; Alzheimer's Disease Cooperative Study. ADCS Prevention Instrument Project: assessment of instrumental activities of daily living for community-dwelling elderly individuals in dementia prevention clinical trials. Alzheimer Dis Assoc Disord. 2006 Oct-Dec;20(4 Suppl 3):S152-69. doi: 10.1097/01.wad.0000213873.25053.2b.
- Background: PubMed 15919186Graham DP, Kunik ME, Doody R, Snow AL. Self-reported awareness of performance in dementia. Brain Res Cogn Brain Res. 2005 Sep;25(1):144-52. doi: 10.1016/j.cogbrainres.2005.05.001.
- Background: PubMed 16980835Bakas T, Champion V, Perkins SM, Farran CJ, Williams LS. Psychometric testing of the revised 15-item Bakas Caregiving Outcomes Scale. Nurs Res. 2006 Sep-Oct;55(5):346-55. doi: 10.1097/00006199-200609000-00007.
- Background: PubMed 18437066Pressler SJ. Cognitive functioning and chronic heart failure: a review of the literature (2002-July 2007). J Cardiovasc Nurs. 2008 May-Jun;23(3):239-49. doi: 10.1097/01.JCN.0000305096.09710.ec.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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 Y Lu, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Engagement 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 12 inclusion and 5 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 15 Jul 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Life Satisfaction (LSITA) (time frame: Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04515875, which also lists 22 linked publications.
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 15 Jul 2026.