PRIMA Intervention for Adults With Mild Cognitive Impairment and Their Caregivers

NCT04515875 | Completed DMC

• 2 other identifiers: IUPREMA08221R01NR018162-01A1
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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 200 patient/caregiver dyads (DEMA intervention vs. the information support (IS) attention control group).

Conditions

Mild Cognitive Impairment

Keywords

Mild cognitive impairment; Quality of life; Family caregivers

Outcome Measures

Primary Outcomes (1)

• Life satisfaction

  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.

  Change from Baseline Life Satisfaction at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention

Secondary Outcomes (5)

• Patient Health Questionnaire-9 Items (PHQ-9)

  Change from Baseline PHQ-9 at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention

• The General Anxiety Disorder 7-item (GAD-7)

  Change from Baseline GAD-7 at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention

• Alzheimer Disease Cooperative Study MCI-Activities of Daily Living Inventory [ADCS-MCI-ADL Scale]

  Change from Baseline ADCS-MCI-ADL at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention

• Relationship Assessment Scale (RAS)

  Change from Baseline RAS at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention

• Caregiving Outcomes Scale (COS)

  Change from Baseline COS at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention

Other Outcomes (11)

• Confidence Scale

  Change Baseline Confidence Scale at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention

• The subscale of Communication and Affective Responsiveness (CAR)

  Change from Baseline subscale of CAR at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention

• Dementia Deficits Scale (DDS) (Patient vs. Caregiver Versions)

  Change from Baseline DDS at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention

Study Arms (2)

Daily Engagement Meaningful Activity (DEMA)

EXPERIMENTAL

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.

Behavioral: Daily Engagement Meaningful Activity (DEMA)

Information Support (IS)

PLACEBO COMPARATOR

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.

Behavioral: Information Support (IS)

Interventions

Daily Engagement Meaningful Activity (DEMA) BEHAVIORAL

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.

Daily Engagement Meaningful Activity (DEMA)

Information Support (IS) BEHAVIORAL

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.

Information Support (IS)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both the MCI patient and caregiver must consent to participate and have a phone at home or daily access to a telephone to be eligible for the study.
• MCI patients will be eligible, if they:
• are aged \> 59 years old;
• able to speak and read English;
• have both self or informant reported cognitive complaints,
• have MoCA score = 15 to 25
• are 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);
• Family caregivers (spouse, other family members or friends) will be eligible, if they
• self-identify as care partner
• are aged ≥ 18 years old,
• have primary responsibility for providing unpaid care to an MCI patient, along with monitoring safety and providing social support;
• are able to speak and read English;
• are oriented to persons, places, and time (having a 6-item Screener score of 4 or above).

You may not qualify if:

• MCI patients and family caregivers will be excluded, if the MCI patient or family caregiver dyads participants are:
• 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).

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Indiana University Alzhemier Disease Research Center

Indianapolis, Indiana, 46202, United States

Location

Related Publications (21)

• 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.

  PMID: 23072638 BACKGROUND

• Plassman 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.

  PMID: 21425187 BACKGROUND

• Ward 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.

  PMID: 24174927 BACKGROUND

• Apostolova 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.

  PMID: 18087152 BACKGROUND

• Kroenke 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.

  PMID: 11556941 BACKGROUND

• Spitzer 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.

  PMID: 16717171 BACKGROUND

• Pedrosa 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.

  PMID: 20922349 BACKGROUND

• Galasko 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.

  PMID: 9236950 BACKGROUND

• Galasko 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.

  PMID: 17135809 BACKGROUND

• Graham 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.

  PMID: 15919186 BACKGROUND

• Bakas 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.

  PMID: 16980835 BACKGROUND

• Pressler 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.

  PMID: 18437066 BACKGROUND

• Deeken 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.

  PMID: 14527761 BACKGROUND

• Nowotny ML. Assessment of hope in patients with cancer: development of an instrument. Oncol Nurs Forum. 1989 Jan-Feb;16(1):57-61.

  PMID: 2911528 BACKGROUND

• Snow 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.

  PMID: 15198084 BACKGROUND

• Law M, Polatajko H, Pollock N, McColl MA, Carswell A, Baptiste S. Pilot testing of the Canadian Occupational Performance Measure: clinical and measurement issues. Can J Occup Ther. 1994 Oct;61(4):191-7. doi: 10.1177/000841749406100403.

  PMID: 10137673 BACKGROUND

• Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.

  PMID: 11132119 BACKGROUND

• Callahan CM, Unverzagt FW, Hui SL, Perkins AJ, Hendrie HC. Six-item screener to identify cognitive impairment among potential subjects for clinical research. Med Care. 2002 Sep;40(9):771-81. doi: 10.1097/00005650-200209000-00007.

  PMID: 12218768 BACKGROUND

• Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

  PMID: 15817019 BACKGROUND

• Jeste DV, Palmer BW, Appelbaum PS, Golshan S, Glorioso D, Dunn LB, Kim K, Meeks T, Kraemer HC. A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007 Aug;64(8):966-74. doi: 10.1001/archpsyc.64.8.966.

  PMID: 17679641 BACKGROUND

• Pfeffer RI, Kurosaki TT, Harrah CH Jr, Chance JM, Filos S. Measurement of functional activities in older adults in the community. J Gerontol. 1982 May;37(3):323-9. doi: 10.1093/geronj/37.3.323.

  PMID: 7069156 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yvonne Y Lu, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: August 17, 2020
• Study Start: December 13, 2021
• Primary Completion: July 20, 2025
• Study Completion: July 20, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)